Abstract: The present patent application relates to treatment of a respiratory disorder using retinoid-related orphan receptor gamma t (ROR-gamma) modulators. Particularly, the present patent application relates to treatment of a respiratory disorder using a ROR? inhibitor, wherein the ROR? inhibitor is administered by an inhalation route to a subject in need thereof.

Abstract: The present invention relates to oral liquid compositions of guanfacine. The liquid. compositions can be immediate release or extended release compositions. The compositions comprise guanfacine in a concentration from about 0.1 mg/mL to about 12.0 mg/mL of the composition. The liquid compositions can be in the form of ready-to use liquid compositions or reconstituted liquid compositions. It further relates to processes for the preparation of said oral liquid compositions.

Abstract: The potency of a series of Hexamethylene bis-acetamide (HMBA) derivatives of formula I, that induce Hexamethylene bis-acetamide inducible protein 1 (HEXIM1) was determined in cancer cells. The method of inducing HEXIM1 expression and cell differentiation in cancer and HIV cells are disclosed. Optimization of HMBA analogs that are symmetrical and unsymmetrical are also discussed.

Abstract: A composition comprising from about 1 weight part to about 10 weight parts a saturated carboxylic acid having from 2 to about 20 carbon atoms; front about 0.1 weight parts to about 10 weight parts an antifungal compound; and from about 80 weight parts to about 99 weight parts skin-penetrating gel; wherein the saturated carboxylic acid, the antifungal compound, and the skin-penetrating gel together comprise 100 weight parts. In a particular example of the composition, the saturated carboxylic acid having from 2 to about 20 carbon atoms is acetic acid; and the antifungal compound is thymol. A method of treating onychomycosis in a patient, comprising applying the composition. The method provides a safe, effective treatment of onychomycosis.

Abstract: The present invention provides a composition comprising HMB. Methods of administering HMB to an animal are also described. HMB is administered to enhance or promote lipolysis, increase adipocyte fat oxidation, induce adipocyte and muscle mitochondrial biogenesis, increase energy expenditure, decrease total body weight and increase body fat loss.

Abstract: A hemostatic composition comprises calcium alginate, a chitosan, epsilon-aminocaproic acid, an acid selected from aminomethylbenzoic acid and tranexamic acid, and tannin. The method of making the hemostatic composition comprises mixing one or more polysaccharide bases, tannin, a fibrinolytic inhibitor, colloidal silver and a solvent to form a mixture, and drying the mixture at a temperature between 25° C. and 80° C. until residual moisture content is approximately 15 to 20%.

Abstract: Compositions and methods for protecting normal, healthy cells during chemotherapy are disclosed. The methods include administering one or more compounds that inhibit the cell cycle of rapidly regenerating normal cells and a chemotherapeutic agent. The cell cycle inhibitors can be administered prior to administration of a chemotherapeutic agent. The chemotherapeutic agents can be ?-substituted ?-amino acids, ?-substituted ?-amino acid derivatives, and ?-substituted ?-amino acid analogs. Pharmaceutical compositions comprising the ?-substituted ?-amino acid derivatives and ?-substituted ?-amino acid analogs and uses thereof are also disclosed. The ?-substituted ?-amino acid derivatives and ?-substituted ?-amino acid analogs can be administered in conjunction with one or more compounds that inhibit the cell cycle of rapidly proliferating normal healthy cells. The cell cycle inhibitors can ameliorate the adverse effects of the ?-substituted ?-amino acid derivatives and ?-substituted ?-amino acid analogs.

Abstract: The present invention provides an oral pharmaceutical composition of isotretinoin having enhanced bioavailability, wherein said composition is in the form of a solid dispersion comprising isotretinoin and a pharmaceutically acceptable matrix. The present invention further relates to a process for preparing the oral pharmaceutical composition of the present invention.

Abstract: Described herein are compositions for parenteral administration that include an aqueous phase and 5 to 30%, by weight, of an oil phase, based on the total weight of the composition. The oil phase comprises the omega-3 fatty acid ethylesters eicosapentaenoic acid ethylester, docosahexaenoic acid ethylester, and mixtures thereof. The composition further comprises at least one anionic surfactant and at least one amphoteric surfactant, and less than 0.05% by weight of oleic acid, based on the total weight of the composition. Also described is a method for preparing such a composition as well as such compositions for use as a medicament, in particular for use in treating stroke, sepsis, Alzheimer's disease or cancer. Also featured are methods of treating these conditions by parenterally administering a composition to a patient in need thereof and methods of providing parenteral nutrition to such patients by administering to them a composition as described herein.

Abstract: The present invention relates to a method for treating muscular dystrophy which comprises administering diethyl-[6-(4-hydroxycarbamoyl-phenyl-carbamoyloxy-methyl)-naphthalen-2-yl-methyl]-ammonium chloride or other pharmaceutically acceptable salts and/or solvates thereof to a patient in need of such a treatment. The invention further relates to a method for treating muscular dystrophy which comprises administering diethyl-[6-(4-hydroxycarbamoyl-phenyl-carbamoyloxy-methyl)-naphthalen-2-yl-methyl]-ammonium chloride or other pharmaceutically acceptable salts and/or solvates thereof in combination with one or more additional anti-inflammatory active agents to a patient in need of such a treatment.

Abstract: The present invention relates to modified or polymer conjugated MetAP2 inhibitors. The present invention also relates to methods of preventing, inducing, causing or increasing weight loss, treating obesity and/or treating metabolic syndrome utilizing the modified or polymer conjugated MetAP2 inhibitors. The present invention also relates to methods of improving insulin sensitivity and glycemic control, reducing insulin levels and/or improving leptin sensitivity utilizing the modified or polymer conjugated MetAP2 inhibitors.

Abstract: Methods for the treatment of systemic disorders treatable with mast cell stabilizers, including mast cell related disorders, are provided.

Abstract: Methods for the treatment of lung diseases with mast cell stabilizers are provided.

Abstract: The invention provides compounds, compositions, and methods for the treatment of diseases, disorders, or conditions that are modulated by matrix metalloproteinases (MMPs). The disease, disorder, or condition can include, for example, stroke, neurological disorders, or ophthalmological disorders. The treatment can include administering a compound or composition described herein, thereby providing a prodrug compound that metabolizes to an active MMP inhibitor in vivo. The MMP inhibition can be selective inhibition, for example, selective inhibition of MMP-2, MMP-9, and/or MMP-14. Thus, the invention provides non-mutagenic prodrug compounds of the formulas described herein that result in the inhibition of MMPs upon in vivo administration.

Abstract: A method administers quaternary ammonium anti-cholinergic muscarinic receptor antagonists in combination with acetyl-cholinesterase inhibitors to treat either cognitive impairment or acute delirium. This therapy results in a modification of a cognitive disorder or disease, namely a slow down in the disease progression. In one preferred embodiment, the disease is dementia with Lewy Bodies. New formulations for quaternary ammonium anti-cholinergic muscarinic receptor antagonists are also disclosed.

Abstract: The present invention relates to (+)-1-(3,4-dichlorophenyl)-3-azabicyclo[3.1.0]hexane and pharmaceutically acceptable active salts, polymorphs, glycosylated derivatives, metabolites, solvates, hydrates, and/or prodrugs of (+)-1-(3,4-dichlorophenyl)-3-azabicyclo[3.1.0]hexane and their use alone or in combination with additional psychotherapeutic compositions in the treatment of conditions affected by monoamine neurotransmitters, including treatment of refractory individuals. (+)-1-(3,4-dichlorophenyl)-3-azabicyclo[3.1.0]hexane compositions are metabolized by either or both MAO-A or cytochrome P450 enzymes and thus are effective in the treatment of individuals with cytochrome P450 polymorphisms or who are taking other medications that affect the cytochrome P450 pathway.

Abstract: This invention relates to, in part, methods and compositions that are useful for the diagnosis, treatment, or prevention of a blinding eye disease, including in the discovery of drugs that are efficacious against these diseases. Diseases include, for example, age related macular degeneration and reticular pseudodrusen disease, and the methods described herein include, for example, the method named delayed near infrared analysis (DNIRA).

Abstract: The invention provides a novel myogenesis promotor, a novel muscle atrophy inhibitor, a novel composition or a novel TAZ activator. The myogenesis promotor, the muscle atrophy inhibitor, the composition and the TAZ activator include a composition represented by the following Formula (I) as an active ingredient. In Formula (I), R1 represents a hydrogen atom or an alkyl group; R2 represents an aryl group, a heterocyclic group, an alkyl group or the like; R3 represents —NR5R6 or —N?C—R7; each of R5 and R6 independently represents a hydrogen atom, an alkyl group or the like; R7 represents —NR10R11, an aryl group or a heterocyclic group; R8 represents a hydrogen atom, an alkyl group or the like; R9 represents a hydrogen atom, an alkyl group or the like; each of R10 and R11 independently represents a hydrogen atom, an alkyl group or the like; R4 represents a cyano group or —C(?O)R12; and R12 represents an aryl group, a heterocyclic group, an alkyl group or the like.

Abstract: Embodiments described herein are directed to novel pharmaceutical compositions comprising a plurality of microgranules comprising nitroimidazole compounds, and uses of these pharmaceutical compositions in the treatment of bacterial vaginosis.

Abstract: A topical composition comprising about 5 wt % to about 12.5 wt % of metronidazole or a pharmacologically acceptable salt thereof in a non-aqueous vehicle. The composition may be used in the treatment of skin damage due to inflammatory skin conditions; thermal, chemical or electrical burns; infections or radiation treatment. One advantage of the composition is that topical administration of metronidazole results in a primarily local effect, and thus, side effects observed from systemic administration are avoided.

Abstract: A compound of formula (I), wherein R3, R4, G, B, M, and Z are as defined in the claims, and pharmaceutically acceptable salts thereof are disclosed. The compounds of formula (I) possess utility as FGFR inhibitors and are useful in the treatment of a condition, where FGFR kinase inhibition is desired, such as cancer.

Abstract: The present invention relates to the screening, diagnosis, prognostic evaluation, and treatment or prevention of age associated inflammation, chronic inflammation, and inflammatory diseases. In particular, the present invention relates to treating or preventing inflammatory diseases (e.g. rheumatoid arthritis or spondyloarthritis) or patients with inflammatory peripheral GnRH with GnRH antagonists or drugs that lower the effects of GnRH.

Abstract: A compound of formula [I-W]: wherein each symbol is as defined in the description, or a pharmaceutically acceptable salt thereof.

Abstract: The present invention relates to low-dose pharmaceutical compositions comprising the aromatase inhibitor 4,4?-[fluoro-(1-H-1,2,4-triazol-1-yl)methylene]bisbenzonitrile, as the active ingredient in a suitable carrier. The present invention also relates to a process for their preparation and to their use as medicaments.

Abstract: The present invention relates to a solid dispersion characterized in that it comprises carbamic acid 3-(4-benzyloxy-phenyl)-isoxazol-5-ylmethyl ester as an active ingredient and a water-soluble polymer having a glass transition temperature lower than the melting point of the active ingredient as a carrier, and it is prepared via melt extrusion. The solid dispersion of the present invention remarkably increases the solubility and dissolution rate of the active ingredient which is an insoluble drug to efficiently improve the bioavailability when it is orally administered.

Abstract: The invention provides compositions and methods for the treatment of presbyopia. The compositions preferably comprise aceclidine and a polyol. The compositions optionally contain a cycloplegic agent, a surfactant, a viscosity enhancer, an osmolarity modifier and a preservative.

Abstract: Compounds of formula (I) defined herein are both phosphodiesterase 4 (PDE4) enzyme inhibitors and muscarinic M3 receptor antagonists and are useful for treating diseases of the respiratory tract.

Abstract: The present invention is based, in part, on our discovery that certain types of therapeutic agents can be used in combination to treat a variety of neuropsychiatric and related disorders, including addiction (e.g., to a substance or to an activity) as well as to alleviate some of the symptoms experienced during menopause or associated with the menstrual cycle. Regardless of the precise formulation, the compositions of the invention can include at least one active ingredient that targets the hypothalamo-pituitary-adrenal (HPA) axis and at least one active ingredient that targets the prefrontal cortex. Either or both of these types of agents can be combined with an agent that inhibits activity in the sympathetic nervous system. Thus, the compositions or combination pharmacotherapies can also include an agent that inhibits a beta-adrenergic receptor or that otherwise acts as an anti-hypertensive or anxiolytic agent.

Abstract: A method of enhancing the activity of lysosomal ?-Galactosidase A (?-Gal A) in mammalian cells and for treatment of Fabry disease by administration of 1-deoxy-galactonojirimycin and related compounds.

Abstract: Disclosed are crystalline free base ansolvate forms of 2-hydroxy-6-((2-(1-isopropyl-1H-pyrazol-5-yl)pyridin-3-yl)methoxy)benzaldehyde (or Compound 1), such as the free base Form I, Form II and Material N. Also disclosed are crystalline free base solvates of 2-hydroxy-6-((2-(1-isopropyl-1H-pyrazol-5-yl)pyridin-3-yl)methoxy)benzaldehyde (or Compound 1).

Abstract: This invention relates to 5-substituted isoindoline compounds, and pharmaceutically acceptable salts, solvates, stereoisomers, and prodrugs thereof. Methods of use, and pharmaceutical compositions of these compounds are disclosed.

Abstract: The invention relates to the use of quaternary pyridinium salts of formula (I), wherein R is NH2, CH3, or N(H)CH2OH group, and X is pharmaceutically acceptable counterion, for the preparation of vasoprotective agent for the treatment or prevention of conditions or diseases associated with dysfunction of vascular endothelium, oxidative stress, and/or insufficient production of endothelial prostacyclin PGI2, in particular but not exclusively if the above coincides with hypercholesterolemia, hypertriglyceridemia or low HDL level.

Abstract: The present invention is directed to compositions for preventing or reducing the flush and other unpleasant symptoms that sometimes accompany the consumption of alcoholic beverages, and methods for use of said compositions. The compositions comprise an agent, or combinations of various agents, such as an agent capable of increasing intracellular or intramitochondrial concentration of NAD in the subject; an agent capable of increasing glutathione concentration in the subject; an anti-oxidant; alpha-lipoic acid or a precursor to alpha-lipoic acid; and/or an agent capable of increasing the level of Coenzyme A in the subject; where the agent or agents are present or administered in amounts effective to prevent or reduce the alcohol reaction in a subject who has consumed one or more alcoholic beverages.

Abstract: The present invention relates to a pharmaceutical composition comprising apixaban, in particular to a pharmaceutical composition comprising apixaban and a polymer having low viscosity as binder, and to a process for its preparation. The pharmaceutical composition is particularly useful as a medicament, especially for the treatment or prevention of a thromboembolic disorder.

Abstract: Compounds of formula (I) defined herein are both phosphodiesterase 4 (PDE4) enzyme inhibitors and muscarinic M3 receptor antagonists and are useful for treating diseases of the respiratrory tract.

Abstract: Described herein are compounds and compositions for treating glaucoma and/or reducing intraocular pressure. Compositions may comprise an isoquinoline compound and a prostaglandin or a prostaglandin analog. Compounds described herein include those in which an isoquinoline compound is covalently linked to a prostaglandin or a prostaglandin analog, and those in which an isoquinoline compound and a prostaglandin free acid together form a salt.

Abstract: The present invention relates to new benzoquinoline inhibitors of vesicular monoamine transporter 2 (VMAT2), pharmaceutical compositions thereof, and methods of use thereof.

Abstract: Compounds of formula I, defined herein, act both as muscarinic receptor antagonists and beta2 adrenergic receptor agonists and are useful for treating diseases of the respiratory tract.

Abstract: Provided are methods for treating breast cancer in a patient by administering effective amounts of liposomal irinotecan sucrosofate (MM-398). The breast cancer may be triple negative breast cancer (TNBC), estrogen receptor/progesterone receptor (ER/PR) positive breast cancer, ER-positive breast cancer, or PR-positive breast cancer, or metastatic breast cancer.

Abstract: The present invention relates to methods for treating pruritus with anti-pruritic compositions.

Abstract: Disclosed are solid oral pharmaceutical compositions that that are intended to provide protection against overdose and tampering, as well as abuse deterrence. The compositions contain a plurality of granules or multi-particulates. A first population of multi particulates contains an API or drug susceptible to abuse, a polymer matrix, and an outer coating that contains a cationic pH dependent polymer. These multi particulates also contain a plasticizer and a surfactant. A second population of multi particulates contains a viscosity building polymer and an alkaline buffering agent. Compositions may further include a disintegrant, and/or additional viscosity building polymers and/or alkaline buffering agents and/or ion exchange polymers. Also disclosed are the methods of making and using the compositions.

Abstract: The present invention relates to injectable, extended-release, pharmaceutical formulations comprising a nalbuphine ester prodrug homogenously dissolved in a solution comprising a pharmaceutically acceptable oil and an oil-miscible retaining solvent, as well as manufacturing processes and medical uses of the formulations. The invention further provides methods for adjusting the duration of action of the formulations by varying the ratio of the pharmaceutically acceptable oil and the oil-miscible retaining solvent.

Abstract: Dosage forms, drug delivery systems, and methods related to sustained release of dextromethorphan or improved therapeutic effects are disclosed. Typically, bupropion or a related compound is orally administered to a human being to be treated with, or being treated with, dextromethorphan.

Abstract: The invention provides compositions and methods for the induction of cell death, for example, cancer cell death. Combinations of compounds and related methods of use are disclosed, including the use of compounds in therapy for the treatment of cancer and selective induction of apoptosis in cells. The disclosed drug combinations can have lower neurotoxicity effects than other compounds and combinations of compounds.

Abstract: There may be provided compositions of lipophilic pharmaceutical agents with improved solubility and stability. For example, there may be provided a non-aqueous composition that comprises a lipophilic pharmaceutical agent, and an amphiphilic polymeric solvent such as PEG400 but essentially free of organic solvents and non-solubilized particles. The composition may be further diluted with a desired aqueous diluent such as an infusion fluid for parenteral administration to a subject such as a human. The compositions may be useful for the treatment for diseases or conditions that are sensitive to lipophilic agents, such as infectious diseases, malignant or autoimmune diseases.

Abstract: Disclosed are methods for treating cisplatin-induced peripheral neuropathy in a subject in need thereof comprising administering to the subject a therapeutically effective amount of a histone deacetylase 6 selective inhibitor.

Abstract: Provided are formulations comprising therapeutically effective amounts of ambrisentan or a pharmaceutically acceptable salt thereof and tadalafil or a pharmaceutically acceptable salt thereof and methods of treating and/or preventing pulmonary hypertension by administration of the formulations.

Abstract: Provided herein is technology relating to treatment of neurological disorders and particularly, but not exclusively, to methods and compositions for treating neurological disorders caused by aberrant and/or dysregulated expression and/or activity of Down syndrome cell adhesion molecule (Dscam) with agents that modulate physiological components associated with the functions and/or dysfunctions of Dscam, e.g., physiological components that can be modulated to counteract aberrant Dscam expression and/or activity such as Abelson murine leukemia viral oncogene homolog 1 kinase.

Abstract: The present invention relates to, inter alia, combinations, methods, compositions, and oral dosage forms of a FAK inhibitor and a MEK inhibitor, for treating abnormal cell growth (e.g., cancer).

Abstract: The invention relates to promoting autophagy in the treatment or prevention of autophagy related disorders, such as various forms of cancer; liver disease, myopathies of various origin; cardiovascular disorders, neurodegenerative disorders by using the compounds of the invention or their pharmaceutically acceptable salts.