Disclosed herein are methods of administering dexmedetomidine or a pharmaceutically acceptable salt thereof to a human subject. The disclosed methods are particularly suitable for the treatment of agitation, especially when associated with neurodegenerative and/or neuropsychiatric diseases or disorders such as dementia and delirium.
A61K 31/4174 - Arylalkylimidazoles, e.g. oxymetazolin, naphazoline, miconazole
A61K 9/00 - Medicinal preparations characterised by special physical form
A61P 25/28 - Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
The present disclosure relates to the treatment of agitation caused by noradrenergic hyperarousal in an agitated subject. The present disclosure provides oromucosal dosage forms comprising effective amounts of latrepirdine either alone or in combination with dexmedetomidine or pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable carriers and/excipients. Methods of their use are also provided. The present disclosure also provides a method of treating depression by administering oromucosally a therapeutically effective amount of dexmedetomidine alone or in combination with latrepirdine.
A61K 31/444 - Non-condensed pyridinesHydrogenated derivatives thereof containing further heterocyclic ring systems containing a six-membered ring with nitrogen as a ring hetero atom, e.g. amrinone
A61K 9/00 - Medicinal preparations characterised by special physical form
A61K 31/4174 - Arylalkylimidazoles, e.g. oxymetazolin, naphazoline, miconazole
A61P 25/18 - Antipsychotics, i.e. neurolepticsDrugs for mania or schizophrenia
3.
COMBINATION OF LATREPIRDINE AND A PHARMACOKINETIC STABILIZER
The present disclosure relates to a pharmaceutical composition comprising a therapeutically effective amount of latrepirdine or a pharmaceutically acceptable salt thereof and an effective amount of a PK stabilizer. The PK stabilizer may be selected from the group consisting of paroxetine, fluoxetine, and quinidine or a pharmaceutically acceptable salt thereof. The PK stabilizer in the composition results in improved pharmacokinetic profile and enhanced therapeutic effect of latrepirdine. The disclosure further relates to treatment of disorders associated with noradrenergic hyperarousal using the pharmaceutical composition.
A61K 31/435 - Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
There is provided a composition suitable for oral transmucosal administration (sublingual) comprising dexmedetomidine. The composition is useful for the treatment of sleep disorders such as insomnia and capable of providing sleep on demand. The composition comprises an effective amount of dexmedetomidine or pharmaceutically acceptable salts thereof, solvates thereof, or derivatives thereof, formulated for delivery of dexmedetomidine across a subject's oral mucosa.
Disclosed herein are methods of administering dexmedetomidine or a pharmaceutically acceptable salt thereof to a human subject. The disclosed methods are particularly suitable for the treatment of agitation, especially when associated with neurodegenerative and/or neuropsychiatric diseases or disorders such as dementia of Alzheimer's type.
Disclosed herein are methods of administering relatively high doses of dexmedetomidine or a pharmaceutically acceptable salt thereof to a human subject, without also inducing significant sedation. The disclosed methods are particularly suitable for the treatment of agitation, especially when associated with neurodegenerative and/or neuropsychiatric diseases such as schizophrenia, bipolar illness such as bipolar disorder or mania, dementia, depression, or delirium.
A01N 37/00 - Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom having three bonds to hetero atoms with at the most two bonds to halogen, e.g. carboxylic acids
A01N 25/00 - Biocides, pest repellants or attractants, or plant growth regulators, characterised by their forms, or by their non-active ingredients or by their methods of applicationSubstances for reducing the noxious effect of the active ingredients to organisms other than pests
A01N 37/12 - Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom having three bonds to hetero atoms with at the most two bonds to halogen, e.g. carboxylic acids containing the group , wherein Cn means a carbon skeleton not containing a ringThio-analogues thereof
A01N 37/44 - Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom having three bonds to hetero atoms with at the most two bonds to halogen, e.g. carboxylic acids containing at least one carboxylic group or a thio-analogue, or a derivative thereof, and a nitrogen atom attached to the same carbon skeleton by a single or double bond, this nitrogen atom not being a member of a derivative or of a thio-analogue of a carboxylic group, e.g. amino-carboxylic acids
A61K 9/00 - Medicinal preparations characterised by special physical form
A61K 31/215 - Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
A61K 31/24 - Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids having an aromatic ring attached to a carboxyl group having an amino or nitro group
A61K 31/4174 - Arylalkylimidazoles, e.g. oxymetazolin, naphazoline, miconazole
The present invention discloses a method of treating agitation or the signs of agitation in a subject comprising the sublingual administration of an effective amount of an alpha-2 adrenergic agonist, more particularly Dexmedetomidine, or a pharmaceutically acceptable salt thereof. The method is particularly suitable for the treatment of agitation associated with neurodegenerative and/or neuropsychiatric diseases. The present invention also discloses die sublingual administration of an alpha-2 adrenergic agonist, more particularly Dexmedetomidine or a pharmaceutically acceptable salt thereof at a dose that is effective to treat agitation or the signs of agitation in a subject, but does not cause significant sedation.
Disclosed herein are methods of administering relatively high doses of dexmedetomidine or a pharmaceutically acceptable salt thereof to a human subject, without also inducing significant sedation. The disclosed methods are particularly suitable for the treatment of agitation, especially when associated with neurodegenerative and/or neuropsychiatric diseases such as schizophrenia, bipolar illness such as bipolar disorder or mania, dementia, depression, or delirium.
A01N 37/00 - Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom having three bonds to hetero atoms with at the most two bonds to halogen, e.g. carboxylic acids
A01N 25/00 - Biocides, pest repellants or attractants, or plant growth regulators, characterised by their forms, or by their non-active ingredients or by their methods of applicationSubstances for reducing the noxious effect of the active ingredients to organisms other than pests
A01N 37/12 - Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom having three bonds to hetero atoms with at the most two bonds to halogen, e.g. carboxylic acids containing the group , wherein Cn means a carbon skeleton not containing a ringThio-analogues thereof
A01N 37/44 - Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom having three bonds to hetero atoms with at the most two bonds to halogen, e.g. carboxylic acids containing at least one carboxylic group or a thio-analogue, or a derivative thereof, and a nitrogen atom attached to the same carbon skeleton by a single or double bond, this nitrogen atom not being a member of a derivative or of a thio-analogue of a carboxylic group, e.g. amino-carboxylic acids
A61K 9/00 - Medicinal preparations characterised by special physical form
A61K 31/215 - Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
A61K 31/24 - Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids having an aromatic ring attached to a carboxyl group having an amino or nitro group
A61K 31/4174 - Arylalkylimidazoles, e.g. oxymetazolin, naphazoline, miconazole
Disclosed herein are methods of administering relatively high doses of dexmedetomidine or a pharmaceutically acceptable salt thereof to a human subject, without also inducing significant sedation. The disclosed methods are particularly suitable for the treatment of agitation, especially when associated with neurodegenerative and/or neuropsychiatric diseases such as schizophrenia, bipolar illness such as bipolar disorder or mania, dementia, depression, or delirium.
A01N 37/00 - Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom having three bonds to hetero atoms with at the most two bonds to halogen, e.g. carboxylic acids
A01N 25/00 - Biocides, pest repellants or attractants, or plant growth regulators, characterised by their forms, or by their non-active ingredients or by their methods of applicationSubstances for reducing the noxious effect of the active ingredients to organisms other than pests
A01N 37/12 - Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom having three bonds to hetero atoms with at the most two bonds to halogen, e.g. carboxylic acids containing the group , wherein Cn means a carbon skeleton not containing a ringThio-analogues thereof
A01N 37/44 - Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom having three bonds to hetero atoms with at the most two bonds to halogen, e.g. carboxylic acids containing at least one carboxylic group or a thio-analogue, or a derivative thereof, and a nitrogen atom attached to the same carbon skeleton by a single or double bond, this nitrogen atom not being a member of a derivative or of a thio-analogue of a carboxylic group, e.g. amino-carboxylic acids
A61K 9/00 - Medicinal preparations characterised by special physical form
A61K 31/215 - Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
A61K 31/24 - Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids having an aromatic ring attached to a carboxyl group having an amino or nitro group
A61K 31/4174 - Arylalkylimidazoles, e.g. oxymetazolin, naphazoline, miconazole
Disclosed herein are methods of administering relatively high doses of dexmedetomidine or a pharmaceutically acceptable salt thereof to a human subject, without also inducing significant sedation. The disclosed methods are particularly suitable for the treatment of agitation, especially when associated with neurodegenerative and/or neuropsychiatric diseases such as schizophrenia, bipolar illness such as bipolar disorder or mania, dementia, depression, or delirium.
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Pharmaceuticals for the treatment of agitation, namely, an orally-dissolving formulation used for the treatment of agitation associated with alcohol withdrawal, opioid use disorder, opioid withdrawal, substance abuse withdrawal, or other central nervous system disorders, namely, dementia and depression
Disclosed herein are methods of administering relatively high doses of dexmedetomidine or a pharmaceutically acceptable salt thereof to a human subject, without also inducing significant sedation. The disclosed methods are particularly suitable for the treatment of agitation, especially when associated with neurodegenerative and/or neuropsychiatric diseases such as schizophrenia, bipolar illness such as bipolar disorder or mania, dementia, depression, or delirium.
A61K 47/26 - Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharidesDerivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
A61K 47/34 - Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
A61K 47/44 - Oils, fats or waxes according to two or more groups of Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
A61P 25/18 - Antipsychotics, i.e. neurolepticsDrugs for mania or schizophrenia
Disclosed herein are methods of administering relatively high doses of dexmedetomidine or a pharmaceutically acceptable salt thereof to a human subject, without also inducing significant sedation. The disclosed methods are particularly suitable for the treatment of agitation, especially when associated with neurodegenerative and/or neuropsychiatric diseases such as schizophrenia, bipolar illness such as bipolar disorder or mania, dementia, depression, or delirium.
A01N 37/00 - Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom having three bonds to hetero atoms with at the most two bonds to halogen, e.g. carboxylic acids
A01N 25/00 - Biocides, pest repellants or attractants, or plant growth regulators, characterised by their forms, or by their non-active ingredients or by their methods of applicationSubstances for reducing the noxious effect of the active ingredients to organisms other than pests
A01N 37/12 - Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom having three bonds to hetero atoms with at the most two bonds to halogen, e.g. carboxylic acids containing the group , wherein Cn means a carbon skeleton not containing a ringThio-analogues thereof
A01N 37/44 - Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom having three bonds to hetero atoms with at the most two bonds to halogen, e.g. carboxylic acids containing at least one carboxylic group or a thio-analogue, or a derivative thereof, and a nitrogen atom attached to the same carbon skeleton by a single or double bond, this nitrogen atom not being a member of a derivative or of a thio-analogue of a carboxylic group, e.g. amino-carboxylic acids
A61K 9/00 - Medicinal preparations characterised by special physical form
A61K 31/215 - Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
A61K 31/24 - Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids having an aromatic ring attached to a carboxyl group having an amino or nitro group
A61K 31/4174 - Arylalkylimidazoles, e.g. oxymetazolin, naphazoline, miconazole
Disclosed herein are methods of administering relatively high doses of dexmedetomidine or a pharmaceutically acceptable salt thereof to a human subject, without also inducing significant sedation. The disclosed methods are particularly suitable for the treatment of agitation, especially when associated with neurodegenerative and/or neuropsychiatric diseases such as schizophrenia, bipolar illness such as bipolar disorder or mania, dementia, depression, or delirium.
A61K 47/26 - Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharidesDerivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
A61K 47/34 - Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
A61K 47/44 - Oils, fats or waxes according to two or more groups of Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
A61P 25/18 - Antipsychotics, i.e. neurolepticsDrugs for mania or schizophrenia
The present disclosure relates to the treatment of agitation caused by noradrenergic hyperarousal in an agitated subject. The present disclosure provides oromucosal dosage forms comprising effective amounts of latrepirdine either alone or in combination with dexmedetomidine or pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable carriers and/excipients. Methods of their use are also provided. The present disclosure also provides a method of treating depression by administering oromucosally a therapeutically effective amount of dexmedetomidine alone or in combination with latrepirdine.
A61K 31/444 - Non-condensed pyridinesHydrogenated derivatives thereof containing further heterocyclic ring systems containing a six-membered ring with nitrogen as a ring hetero atom, e.g. amrinone
A61K 9/00 - Medicinal preparations characterised by special physical form
A61K 31/4174 - Arylalkylimidazoles, e.g. oxymetazolin, naphazoline, miconazole
A61P 25/18 - Antipsychotics, i.e. neurolepticsDrugs for mania or schizophrenia
16.
METHODS FOR TREATING AGITATION IN COMMUNITY SETTINGS
The present disclosure relates to methods of treating agitation in a patient having schizophrenia or a bipolar disorder in a non-clinical setting, comprising administering oromucosally an effective amount of dexmedetomidine or a pharmaceutically acceptable salt thereof to the patient. In embodiments, a caregiver administers dexmedetomidine or a pharmaceutically acceptable salt thereof to the patient or the dexmedetomidine or a pharmaceutically acceptable salt thereof is self-administered by the patient.
A61K 31/395 - Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
A61K 31/41 - Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which is nitrogen, e.g. tetrazole
The present disclosure relates to the treatment of disorders associated with noradrenergic hyperarousal in a human subject. The present disclosure also provides a method of treating acute stress disorder (ASD) comprising administering a therapeutically effective amount of latrepirdine or dexmedetomidine or pharmaceutically acceptable salts thereof. The present disclosure also provides a method of treating autism spectrum disorders in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of latrepirdine or dexmedetomidine alone or a combination thereof. The present disclosure provides oromucosal dosage forms comprising effective amounts of latrepirdine either alone or in combination with dexmedetomidine or pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable carriers and/excipients. Methods of their use are also provided. The present disclosure also provides a method of treating depression by administering oromucosally a therapeutically effective amount of dexmedetomidine alone or in combination with latrepirdine.
Disclosed herein are methods of administering relatively high doses of dexmedetomidine or a pharmaceutically acceptable salt thereof to a human subject, without also inducing significant sedation. The disclosed methods are particularly suitable for the treatment of agitation, especially when associated with neurodegenerative and/or neuropsychiatric diseases such as schizophrenia, bipolar illness such as bipolar disorder or mania, dementia, depression, or delirium.
Disclosed herein are methods and composition for treating bipolar disorders and psychosis by administering dexmedetomidine. The methods and composition alleviate mania, hypomania, psychosis, and depression in the subjects, providing improved therapeutic outcomes.
Disclosed herein is a self-supporting, dissolvable, film containing dexmedetomidine or a pharmaceutically acceptable salt thereof. The film is administered orally to treat various conditions, particularly agitation, by transmucosal delivery of the active agent.
A61K 47/34 - Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
Disclosed herein is a self-supporting, dissolvable, film containing dexmedetomidine or a pharmaceutically acceptable salt thereof. The film is administered orally to treat various conditions, particularly agitation, by transmucosal delivery of the active agent.
A61K 47/34 - Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
Disclosed herein are methods of administering relatively high doses of dexmedetomidine or a pharmaceutically acceptable salt thereof to a human subject, without also inducing significant sedation. The disclosed methods are particularly suitable for the treatment of agitation, especially when associated with neurodegenerative and/or neuropsychiatric diseases such as schizophrenia, bipolar illness such as bipolar disorder or mania, dementia, depression, or delirium.
A01N 37/00 - Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom having three bonds to hetero atoms with at the most two bonds to halogen, e.g. carboxylic acids
A61K 31/215 - Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
A01N 37/12 - Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom having three bonds to hetero atoms with at the most two bonds to halogen, e.g. carboxylic acids containing the group , wherein Cn means a carbon skeleton not containing a ringThio-analogues thereof
A01N 37/44 - Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom having three bonds to hetero atoms with at the most two bonds to halogen, e.g. carboxylic acids containing at least one carboxylic group or a thio-analogue, or a derivative thereof, and a nitrogen atom attached to the same carbon skeleton by a single or double bond, this nitrogen atom not being a member of a derivative or of a thio-analogue of a carboxylic group, e.g. amino-carboxylic acids
A61K 31/24 - Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids having an aromatic ring attached to a carboxyl group having an amino or nitro group
A01N 25/00 - Biocides, pest repellants or attractants, or plant growth regulators, characterised by their forms, or by their non-active ingredients or by their methods of applicationSubstances for reducing the noxious effect of the active ingredients to organisms other than pests
A61K 31/4174 - Arylalkylimidazoles, e.g. oxymetazolin, naphazoline, miconazole
A61K 9/00 - Medicinal preparations characterised by special physical form
Disclosed herein are methods of administering relatively high doses of dexmedetomidine or a pharmaceutically acceptable salt thereof to a human subject, without also inducing significant sedation. The disclosed methods are particularly suitable for the treatment of agitation, especially when associated with neurodegenerative and/or neuropsychiatric diseases such as schizophrenia, bipolar illness such as bipolar disorder or mania, dementia, depression, or delirium.
A61K 47/26 - Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharidesDerivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
A61K 47/34 - Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
A61K 47/44 - Oils, fats or waxes according to two or more groups of Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
A61P 25/18 - Antipsychotics, i.e. neurolepticsDrugs for mania or schizophrenia
The present invention discloses a method of treating agitation or the signs of agitation in a subject comprising the sublingual administration of an effective amount of an alpha-2 adrenergic agonist, more particularly Dexmedetomidine, or a pharmaceutically acceptable salt thereof. The method is particularly suitable for the treatment of agitation associated with neurodegenerative and/or neuropsychiatric diseases. The present invention also discloses the sublingual administration of an alpha-2 adrenergic agonist, more particularly Dexmedetomidine or a pharmaceutically acceptable salt thereof at a dose that is effective to treat agitation or the signs of agitation in a subject, but does not cause significant sedation.
Disclosed herein is a self-supporting, dissolvable, film containing dexmedetomidine or a pharmaceutically acceptable salt thereof. The film is administered orally to treat various conditions, particularly agitation, by transmucosal delivery of the active agent.
A61K 47/34 - Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
Disclosed herein are methods of administering relatively high doses of dexmedetomidine or a pharmaceutically acceptable salt thereof to a human subject, without also inducing significant sedation. The disclosed methods are particularly suitable for the treatment of agitation, especially when associated with neurodegenerative and/or neuropsychiatric diseases such as schizophrenia, bipolar illness such as bipolar disorder or mania, dementia, depression, or delirium.
A61K 47/26 - Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharidesDerivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
A61K 47/34 - Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
A61K 47/44 - Oils, fats or waxes according to two or more groups of Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
27.
USE OF SUBLINGUAL DEXMEDETOMIDINE FOR THE TREATMENT OF AGITATION
The present invention discloses a method of treating agitation or the signs of agitation in a subject comprising the sublingual administration of an effective amount of an alpha-2 adrenergic agonist, more particularly Dexmedetomidine, or a pharmaceutically acceptable salt thereof. The method is particularly suitable for the treatment of agitation associated with neurodegenerative and/or neuropsychiatric diseases. The present invention also discloses the sublingual administration of an alpha-2 adrenergic agonist, more particularly Dexmedetomidine or a pharmaceutically acceptable salt thereof at a dose that is effective to treat agitation or the signs of agitation in a subject, but does not cause significant sedation.
The present invention discloses a method of treating agitation or the signs of agitation in a subject comprising the sublingual administration of an effective amount of an alpha-2 adrenergic agonist, more particularly Dexmedetomidine, or a pharmaceutically acceptable salt thereof. The method is particularly suitable for the treatment of agitation associated with neurodegenerative and/or neuropsychiatric diseases. The present invention also discloses the sublingual administration of an alpha-2 adrenergic agonist, more particularly Dexmedetomidine or a pharmaceutically acceptable salt thereof at a dose that is effective to treat agitation or the signs of agitation in a subject, but does not cause significant sedation.
The present disclosure relates to method of treating or preventing depression in a human subject having Major Depressive Disorder or a Major Depressive Episode, the method comprising (a) an induction phase, comprising administering to the subject a therapeutic amount of dexmedetomidine or a pharmaceutically acceptable salt thereof in combination with a therapeutic amount of a selective serotonin reuptake inhibitor (SSRI)/serotonin norepinephrine reuptake inhibitors (SNRI) from about 1 day to about 28 days, followed by (b) a maintenance phase comprising administering to the subject a therapeutic amount of the SSRI/SNRI.
A61K 31/4174 - Arylalkylimidazoles, e.g. oxymetazolin, naphazoline, miconazole
A61P 25/00 - Drugs for disorders of the nervous system
C07D 405/00 - Heterocyclic compounds containing both one or more hetero rings having oxygen atoms as the only ring hetero atoms, and one or more rings having nitrogen as the only ring hetero atom
30.
SYSTEMS AND METHODS FOR DETECTION AND PREVENTION OF EMERGENCE OF AGITATION
Disclosed in the present disclosure is a method, system and apparatus for prediction, estimation and prevention of occurrence of agitation episode in a subject predisposed to agitation. The method comprises receiving, from a first monitoring device attached to a subject, physiological data of sympathetic nervous system activity in the subject and activity data of the subject; receiving, from a computing device, a plurality of indications associated with a plurality of agitation episodes of the subject; analyzing, using at least one machine learning model, the physiological data, the activity data, and the plurality of indications to determine a probability of an occurrence of an agitation episode of the subject; and sending a signal to a second monitoring device to notify the second monitoring device of the probability of the occurrence of the agitation episode of the subject such that treatment can be provided to the subject to decrease sympathetic nervous system activity in the subject.
The present disclosure relates to the treatment of agitation caused by noradrenergic hyperarousal in an agitated subject. The present disclosure provides oromucosal dosage forms comprising effective amounts of latrepirdine either alone or in combination with dexmedetomidine or pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable carriers and/excipients. Methods of their use are also provided. The present disclosure also provides a method of treating depression by administering oromucosally a therapeutically effective amount of dexmedetomidine alone or in combination with latrepirdine.
Disclosed herein are methods of administering dexmedetomidine or a pharmaceutically acceptable salt thereof to a human subject. The disclosed methods are particularly suitable for the treatment of agitation, especially when associated with neurodegenerative and/or neuropsychiatric diseases or disorders such as dementia and delirium.
A61K 31/4174 - Arylalkylimidazoles, e.g. oxymetazolin, naphazoline, miconazole
A61K 9/00 - Medicinal preparations characterised by special physical form
A61P 25/28 - Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
Disclosed herein are methods of administering dexmedetomidine or a pharmaceutically acceptable salt thereof to a human subject. The disclosed methods are particularly suitable for the treatment of agitation, especially when associated with neurodegenerative and/or neuropsychiatric diseases or disorders such as dementia and delirium.
In some embodiments, a method includes receiving first physiological data of sympathetic nervous system activity and establishing a baseline value of at least one physiological parameter by training at least one machine learning model using the first physiological data. The method further includes receiving, from a first monitoring device attached to a subject, second physiological data of sympathetic nervous system activity in the subject. Using the at least one machine learning model and based on the baseline value of at least one physiological parameter, the method includes analyzing the second physiological data to predict an agitation episode of the subject and sending a signal to a second monitoring device to notify of the prediction of the agitation episode of the subject such that treatment can be provided to the subject to decrease sympathetic nervous system activity in the subject.
Disclosed herein is a self-supporting, dissolvable, film containing dexmedetomidine or a pharmaceutically acceptable salt thereof. The film is administered orally to treat various conditions, particularly agitation, by transmucosal delivery of the active agent.
A61K 9/00 - Medicinal preparations characterised by special physical form
A61K 31/4174 - Arylalkylimidazoles, e.g. oxymetazolin, naphazoline, miconazole
A61K 47/34 - Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
36.
Film formulations containing dexmedetomidine and methods of producing them
Disclosed herein is a self-supporting, dissolvable, film containing dexmedetomidine or a pharmaceutically acceptable salt thereof. The film is administered orally to treat various conditions, particularly agitation, by transmucosal delivery of the active agent.
A61K 31/4174 - Arylalkylimidazoles, e.g. oxymetazolin, naphazoline, miconazole
A61K 47/34 - Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
37.
Film formulations containing dexmedetomidine and methods of producing them
Disclosed herein is a self-supporting, dissolvable, film containing dexmedetomidine or a pharmaceutically acceptable salt thereof. The film is administered orally to treat various conditions, particularly agitation, by transmucosal delivery of the active agent.
A61K 9/00 - Medicinal preparations characterised by special physical form
A61K 31/4174 - Arylalkylimidazoles, e.g. oxymetazolin, naphazoline, miconazole
A61K 47/34 - Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
38.
TREATMENT OF BIPOLAR DISORDERS AND PSYCHOSIS USING DEXMEDETOMIDINE HYDROCHLORIDE
Disclosed herein are methods and composition for treating bipolar disorders and psychosis by administering dexmedetomidine. The methods and composition alleviate mania, hypomania, psychosis, and depression in the subjects, providing improved therapeutic outcomes.
The present invention discloses a method of treating agitation or the signs of agitation in a subject comprising the sublingual administration of an effective amount of an alpha-2 adrenergic agonist, more particularly Dexmedetomidine, or a pharmaceutically acceptable salt thereof. The method is particularly suitable for the treatment of agitation associated with neurodegenerative and/or neuropsychiatric diseases. The present invention also discloses the sublingual administration of an alpha-2 adrenergic agonist, more particularly Dexmedetomidine or a pharmaceutically acceptable salt thereof at a dose that is effective to treat agitation or the signs of agitation in a subject, but does not cause significant sedation.
The present disclosure relates to the treatment of agitation or signs of agitation in certain human subjects, including subjects with a neurodegenerative, neuropsychiatric or opioid withdrawal disorder, by administering dexmedetomidine hydrochloride by the intravenous route.
Disclosed in the present disclosure is a method, system and apparatus for prediction, estimation and prevention of occurrence of agitation episode in a subject predisposed to agitation. The method comprises receiving, from a first monitoring device attached to a subject, physiological data of sympathetic nervous system activity in the subject and activity data of the subject; receiving, from a computing device, a plurality of indications associated with a plurality of agitation episodes of the subject; analyzing, using at least one machine learning model, the physiological data, the activity data, and the plurality of indications to determine a probability of an occurrence of an agitation episode of the subject; and sending a signal to a second monitoring device to notify the second monitoring device of the probability of the occurrence of the agitation episode of the subject such that treatment can be provided to the subject to decrease sympathetic nervous system activity in the subject.
G06F 15/18 - in which a program is changed according to experience gained by the computer itself during a complete run; Learning machines (adaptive control systems G05B 13/00;artificial intelligence G06N)
42.
TREATMENT REGIMEN FOR CANCER USING IMMUNOMODULATION
The present disclosure provides a regimen for treating a subject afflicted with prostate cancer by administering Talabostat or a pharmaceutically acceptable salt thereof and Pembrolizumab, wherein Talabostat or a pharmaceutically acceptable salt thereof is administered at a dose of about 0.3 mg twice daily on one or more days of a treatment cycle. The disclosure further relates to a treatment regimen or a method comprising said combination to treat one or more solid tumors.
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Pharmaceuticals for the treatment of agitation;
pharmaceuticals for the treatment of agitation associated
with neuropsychiatric conditions, neurodegenerative
diseases, alcohol withdrawal, opioid use disorder, opioid
withdrawal, substance abuse withdrawal, or other central
nervous system disorders.
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Pharmaceuticals for the treatment of agitation;
pharmaceuticals for the treatment of agitation associated
with neuropsychiatric conditions, neurodegenerative
diseases, alcohol withdrawal, opioid use disorder, opioid
withdrawal, substance abuse withdrawal, or other central
nervous system disorders.
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
(1) Pharmaceuticals for the treatment of agitation, namely, an orally-dissolving formulation used for the treatment of agitation associated with alcohol withdrawal, opioid use disorder, opioid withdrawal, substance abuse withdrawal, and other central nervous system disorders, namely, Alzheimer disease, frontotemporal dementia (FTD), dementia, dementia with Lewy bodies (DLB), post-traumatic stress disorder, Parkinson's disease, vascular dementia, vascular cognitive impairment, Huntington's disease, multiple sclerosis, Creutzfeldt-Jakob disease, multiple system atrophy, progressive supranuclear palsy, senile dementia of the Alzheimer type (SDAT), schizophrenia, bipolar disorder, bipolar mania, delirium, depression, major depression, and mood disorders.
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
(1) Pharmaceuticals for the treatment of agitation, namely, an orally-dissolving formulation used for the treatment of agitation associated with alcohol withdrawal, opioid use disorder, opioid withdrawal, substance abuse withdrawal, or other central nervous system disorders, namely, Alzheimer disease, frontotemporal dementia (FTD), dementia, dementia with Lewy bodies (DLB), post-traumatic stress disorder, Parkinson's disease, vascular dementia, vascular cognitive impairment, Huntington's disease, multiple sclerosis, Creutzfeldt-Jakob disease, multiple system atrophy, progressive supranuclear palsy, senile dementia of the Alzheimer type (SDAT), schizophrenia, bipolar disorder, bipolar mania, delirium, depression, major depression, and mood disorders.
47.
SYSTEMS AND METHODS FOR DETECTION AND PREVENTION OF EMERGENCE OF AGITATION
Disclosed in the present disclosure is a method, system and apparatus for diagnosing an impending agitation episode in a subject predisposed to agitation. The disclosed method includes monitoring one or more physiological signals of sympathetic nervous system activity in the subject using an automated sensoring device placed or mounted on the subject's skin surface; and identifying, via the processing of incoming data in the device, when the subject is about to have an agitation episode. The disclosure provides a solution for measuring the signs of an impending agitation event, and alerts the caregiver to treat the subject before the emergence of agitation and a suitable treatment thereof.
Disclosed herein is a self-supporting, dissolvable, film containing dexmedetomidine or a pharmaceutically acceptable salt thereof. The film is administered orally to treat various conditions, particularly agitation, by transmucosal delivery of the active agent.
A61K 47/34 - Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
Disclosed herein are methods of administering relatively high doses of dexmedetomidine or a pharmaceutically acceptable salt thereof to a human subject, without also inducing significant sedation. The disclosed methods are particularly suitable for the treatment of agitation, especially when associated with neurodegenerative and/or neuropsychiatric diseases such as schizophrenia, bipolar illness such as bipolar disorder or mania, dementia, depression, or delirium.
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Pharmaceuticals for the treatment of agitation; pharmaceuticals for the treatment of agitation associated with neuropsychiatric conditions, or other central nervous system disorders
51.
Film formulations containing dexmedetomidine and methods of producing them
Disclosed herein is a self-supporting, dissolvable, film containing dexmedetomidine or a pharmaceutically acceptable salt thereof. The film is administered orally to treat various conditions, particularly agitation, by transmucosal delivery of the active agent.
A61K 47/34 - Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Pharmaceuticals for the treatment of agitation, namely, an orally-dissolving formulation used for the treatment of agitation associated with central nervous system disorders, namely, schizophrenia and bipolar disorder
05 - Pharmaceutical, veterinary and sanitary products
42 - Scientific, technological and industrial services, research and design
Goods & Services
(1) Pharmaceutical preparations for use in immuno-oncology; pharmaceutical preparations for the treatment of neurological conditions (1) Pharmaceutical research and development in the fields of neuroscience and immuno-oncology
05 - Pharmaceutical, veterinary and sanitary products
42 - Scientific, technological and industrial services, research and design
Goods & Services
(1) Pharmaceutical preparations for use in immuno-oncology; pharmaceutical preparations for the treatment of neurological conditions (1) Pharmaceutical research and development in the fields of neuroscience and immuno-oncology
05 - Pharmaceutical, veterinary and sanitary products
42 - Scientific, technological and industrial services, research and design
Goods & Services
Pharmaceutical preparations in the field of immuno-oncology; pharmaceutical preparations for the treatment of neurological conditions. Pharmaceutical research and development in the fields of neuroscience and immuno-oncology.
05 - Pharmaceutical, veterinary and sanitary products
42 - Scientific, technological and industrial services, research and design
Goods & Services
Pharmaceutical preparations in the field of immuno-oncology; pharmaceutical preparations for the treatment of neurological conditions. Pharmaceutical research and development in the fields of neuroscience and immuno-oncology.
57.
NOVEL APPROACH FOR TREATMENT OF CANCER USING IMMUNOMODULATION
The present disclosure provides a regimen for treating a subject afflicted with prostate cancer by administering Talabostat or a pharmaceutically acceptable salt thereof and Pembrolizumab. The present disclosure is based on the discovery that the combination of Talabostat or a pharmaceutically acceptable salt thereof and Pembrolizumab in a specific treatment regimen is a very effective therapy to treat subjects afflicted with prostate cancer.
A61K 31/40 - Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
The present disclosure provides methods of treating cancer comprising administering a selective dipeptidyl peptidase inhibitor and an OX40 agonist with or without one or more immune checkpoint inhibitors to a subject with cancer. The present disclosure provides pharmaceutical compositions for treating cancer comprising a selective dipeptidyl peptidase inhibitor and an OX40 agonist with or without one or more immune checkpoint inhibitors.
A61K 31/58 - Compounds containing cyclopenta[a]hydrophenanthrene ring systemsDerivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
A61K 39/395 - AntibodiesImmunoglobulinsImmune serum, e.g. antilymphocytic serum
C12Q 1/68 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving nucleic acids
C07K 14/46 - Peptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from animalsPeptides having more than 20 amino acidsGastrinsSomatostatinsMelanotropinsDerivatives thereof from humans from vertebrates
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
A61P 35/02 - Antineoplastic agents specific for leukemia
A61P 35/04 - Antineoplastic agents specific for metastasis
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Pharmaceuticals for the treatment of agitation; pharmaceuticals for the treatment of agitation associated with neuropsychiatric conditions, neurodegenerative diseases, alcohol withdrawal, opioid use disorder, opioid withdrawal, substance abuse withdrawal, or other central nervous system disorders.
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Injectable pharmaceuticals for the treatment of agitation; injectable pharmaceuticals for the treatment of agitation associated with neuropsychiatric conditions, neurodegenerative diseases, alcohol withdrawal, opioid use disorder, opioid withdrawal, substance abuse withdrawal and other related central nervous system disorder; all of the aforesaid goods only being provided via prescription; none of the aforementioned goods being provided being herbal preparations, natural preparations; none of the aforesaid goods being exclusively indicated for the treatment of insomnia.
05 - Pharmaceutical, veterinary and sanitary products
42 - Scientific, technological and industrial services, research and design
Goods & Services
Pharmaceutical preparations in the field of immuno-oncology; pharmaceutical preparations for the treatment of neurological conditions Pharmaceutical research and development in the fields of neuroscience and immuno-oncology
05 - Pharmaceutical, veterinary and sanitary products
42 - Scientific, technological and industrial services, research and design
Goods & Services
Pharmaceutical preparations in the field of immuno-oncology; pharmaceutical preparations for the treatment of neurological conditions Pharmaceutical research and development in the fields of neuroscience and immuno-oncology
64.
METHODS FOR TREATING AGITATION USING DEXMEDETOMIDINE HYDROCHLORIDE
The present disclosure relates to the treatment of agitation or signs of agitation in certain human subjects, including subjects with a neurodegenerative, neuropsychiatric or opioid withdrawal disorder, by administering dexmedetomidine hydrochloride by the intravenous route.
Disclosed herein is a self-supporting, dissolvable, film containing dexmedetomidine or a pharmaceutically acceptable salt thereof. The film is administered orally to treat various conditions, particularly agitation, by transmucosal delivery of the active agent.
A61K 47/34 - Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
66.
FILM FORMULATIONS CONTAINING DEXMEDETOMIDINE AND METHODS OF PRODUCING THEM
Disclosed herein is a self-supporting, dissolvable, film containing dexmedetomidine or a pharmaceutically acceptable salt thereof. The film is administered orally to treat various conditions, particularly agitation, by transmucosal delivery of the active agent.
The present invention discloses a method of treating agitation or the signs of agitation in a subject comprising the sublingual administration of an effective amount of an alpha-2 adrenergic agonist, more particularly Dexmedetomidine, or a pharmaceutically acceptable salt thereof. The method is particularly suitable for the treatment of agitation associated with neurodegenerative and/or neuropsychiatric diseases. The present invention also discloses the sublingual administration of an alpha-2 adrenergic agonist, more particularly Dexmedetomidine or a pharmaceutically acceptable salt thereof at a dose that is effective to treat agitation or the signs of agitation in a subject, but does not cause significant sedation.
Provided herein are combination methods and compositions for cancer therapies. The combinations modify multiple arms of the immune system, including an innate immunity modifier, an immune checkpoint inhibitor and a T-cell stimulator, to treat cancer.
A61K 39/395 - AntibodiesImmunoglobulinsImmune serum, e.g. antilymphocytic serum
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
69.
PREDICTIVE AND DIAGNOSTIC METHODS FOR PROSTATE CANCER
The present invention generally relates to a method of diagnosing, prognosing and treating prostate cancer patients. Particularly, the present invention relates to a method of selecting patients with castration resistant prostate cancer (CrPC) for combination therapy comprising a selective dipeptidyl peptidase inhibitor and a PD-1 axis antagonist. The present invention provides a computational approach to identifying potential patients for CrPC. The present invention also relates to a method of treating castration resistant prostate cancer (CrPC) patients with said combination therapy.
A61K 31/58 - Compounds containing cyclopenta[a]hydrophenanthrene ring systemsDerivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
A61K 39/395 - AntibodiesImmunoglobulinsImmune serum, e.g. antilymphocytic serum
C07J 43/00 - Normal steroids having a nitrogen-containing hetero ring spiro-condensed or not condensed with the cyclopenta[a]hydrophenanthrene skeleton
C12Q 1/68 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving nucleic acids
C07K 16/28 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
70.
USE OF SUBLINGUAL DEXMEDETOMIDINE FOR THE TREATMENT OF AGITATION
The present invention discloses a method of treating agitation or the signs of agitation in a subject comprising the sublingual administration of an effective amount of an alpha-2 adrenergic agonist, more particularly Dexmedetomidine, or a pharmaceutically acceptable salt thereof. The method is particularly suitable for the treatment of agitation associated with neurodegenerative and/or neuropsychiatric diseases. The present invention also discloses the sublingual administration of an alpha-2 adrenergic agonist, more particularly Dexmedetomidine or a pharmaceutically acceptable salt thereof at a dose that is effective to treat agitation or the signs of agitation in a subject, but does not cause significant sedation.
The present invention discloses a method of treating, preventing or ameliorating tumor growth by administering a therapeutic agent that selectively inhibits dipeptidyl peptidase including fibroblast activation protein and dipeptidyl peptidase 8/9 in combination with an immune checkpoint inhibitor. The method specifically discloses use of Talabostat in combination with an immune checkpoint inhibitor, its pharmaceutical composition and process of preparing such composition.
A61K 45/08 - Mixtures of an active ingredient and an auxiliary substance neither being chemically characterised, e.g. antihistaminicum and surface active substance
A61K 38/04 - Peptides having up to 20 amino acids in a fully defined sequenceDerivatives thereof
C07K 16/24 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
C12N 15/11 - DNA or RNA fragmentsModified forms thereof
