Abstract: Applicant provides methods of treating diseases including Cushing's syndrome and hormone-sensitive cancers by concomitant administration of a glucocorticoid receptor modulator (GRM) and steroidogenesis inhibitors, and by concomitant administration of a GRM and CYP3A inhibitors. The GRM may be, e.g., mifepristone; the CYP3A inhibitors or steroidogenesis inhibitors (collectively “inhibitors”) may be, e.g., ketoconazole or itraconazole. Inhibitors may cause toxicity or other serious adverse reactions; concomitant administration of inhibitors with other drugs may increase the risk of such toxicity and adverse reactions due to the inhibitors and/or the other drugs. Applicant has surprisingly found that GRMs may be administered to subjects receiving inhibitors without increasing the risk of adverse reactions; for example, Applicant has found that mifepristone may be concomitantly administered with ketoconazole or itraconazole, providing safe concomitant administration of the GRM and ketoconazole or itraconazole.

Abstract: The present disclosure provides pharmaceutical compositions of niclosamide that may be administered either orally or by inhalation. These compositions may allow the achievement of a therapeutically effective dose of niclosamide to the lungs or the gastrointestinal tract. These compositions may be used to treat one or more diseases or disorders such as a viral infection or cancer.

Abstract: The present invention relates to compositions comprising N,N-dimethyltryptamine, deuterated N,N-dimethyltryptamine and/or partially deuterated N,N-dimethyltryptamine. In particular, the present invention relates to compositions comprising a combination of N,N-dimethyltryptamine and 2% or more by weight of one or more deuterated N,N-dimethyltryptamine compound selected from ?,?-dideutero-N,N-dimethyltryptamine and ?,?,?,?-tetradeutero-N,N-dimethyltryptamine. Additional and alternative compositions of the present invention comprise a combination of N,N-dimethyltryptamine and 2% or more by weight of one or more partially deuterated N,N-dimethyltryptamine compound selected from ?,?,?-trideutero-N,N-dimethyltryptamine, ?,?-dideutero-N,N-dimethyltryptamine, and ?-deutero-N,N-dimethyltryptamine.

Abstract: In one aspect, use of 1-palmitoyl-2-linoleoyl-3-acetylglycerol (PLAG) for treating or preventing acute radiation syndrome is provided.

Abstract: The present application includes a composition comprising a non-racemic mixture a compound of Formula (R)-I, or a salt and/or solvate thereof, and (S)-I, or a salt and/or solvate thereof: wherein (R)-I, or a salt and/or solvate thereof, is present in the composition in a greater amount by enantiomeric equivalents, relative to (S)-I, or a salt and/or solvate thereof. Also included are methods of using these compositions for treating, for example, a psychiatric disorder. The compounds of Formula (R)-I and (S)-I include the enantiomers of 3,4-methylenedioxymethamphetamine (MDMA) and N-methyl-1,3-benzodioxolylbutanamine (MBDB). Also included in the present application is a method for treating various diseases, disorders or conditions using a therapeutically effective amount of (R)-MDMA, or a pharmaceutically acceptable salt and/or solvate thereof.

Abstract: The present disclosure provides crystalline polymorphic forms of TG02 free base and TG02 acid addition salts, pharmaceutical compositions comprising crystalline polymorphic forms of TG02 free base and TG02 acid addition salts, and methods of treating cancer and other diseases in a patient with crystalline polymorphic forms of TG02 free base and TG02 acid addition salts.

Abstract: The present disclosure is directed to a method of treating prediabetes or type 1 or type 2 diabetes mellitus comprising administering to a subject in need thereof an effective amount of imeglimin, wherein the subject has chronic kidney disease.

Abstract: The disclosure provides methods for the acute treatment of depression and/or anxiety, for the enhancement of mTOR (e.g., mTORC1) signaling, and for the reduction of neuroinflammation, comprising administering to a patient in need thereof, a therapeutically effective amount of a 5-HT2A/mu-opioid receptor or 5-HT2A/D1 and/or D2/mu-opioid receptor ligand.

Abstract: A method of feeding an aquaculture of an aquatic animal species of interest is provided. The method comprising providing the aquaculture with an aquaculture feed comprising a sub-optimal dose of protein and an effective amount of butyric acid or salt thereof, the effective amount facilitating reducing feed conversion ratio (FCR). Also provided are feed compositions for aquaculturing.

Abstract: Applicant provides methods of treating diseases including Cushing's syndrome and hormone-sensitive cancers by concomitant administration of a glucocorticoid receptor modulator (GRM) and steroidogenesis inhibitors, and by concomitant administration of a GRM and CYP3A inhibitors. The GRM may be, e.g., mifepristone; the CYP3A inhibitors or steroidogenesis inhibitors (collectively “inhibitors”) may be, e.g., ketoconazole or itraconazole. Inhibitors may cause toxicity or other serious adverse reactions; concomitant administration of inhibitors with other drugs may increase the risk of such toxicity and adverse reactions due to the inhibitors and/or the other drugs. Applicant has surprisingly found that GRMs may be administered to subjects receiving inhibitors without increasing the risk of adverse reactions; for example, Applicant has found that mifepristone may be concomitantly administered with ketoconazole or itraconazole, providing safe concomitant administration of the GRM and ketoconazole or itraconazole.

Abstract: The disclosure relates to a method for treatment of cancer comprising administering to a subject in need thereof a first agent in a therapeutically effective amount and a second agent in a therapeutically effective amount. Preferably, the first agent comprises an EZH2 inhibitor, e.g., tazemetostat or a pharmaceutically acceptable salt thereof. In certain embodiments, the methods of the disclosure are used to treat breast cancer, ovarian cancer, or both.

Abstract: A topical composition for treating genital herpes includes dimethyl sulfoxide (DMSO), a diluent, and a quaternary ammonium compound. The topical composition may further contain a cannabinoid component, such as CBD, and/or a terpene and/or an essential oil. The topical composition may be in the form of a two-component composition in which a first topical composition includes dimethyl sulfoxide (DMSO), a diluent, and a quaternary ammonium compound and the second topical composition includes dimethyl sulfoxide (DMSO), a diluent, and a cannabinoid component.

Abstract: Treatments for therapy of a diabetic symmetrical polyneuropathy a subject in need thereof. The treatments includes administration of compositions comprising: an effective amount of a muscarinic acetylcholine receptor antagonist exemplified by pirenzepine, telenzepine, atropine, or derivatives thereof or salts thereof or analogs thereof or derivatives thereof, and a pharmacologically acceptable carrier. The composition may be injectable or alternatively, may be applied topically or alternatively, may be delivered orally. A suitable topical composition may comprise a lotion, a cream, a gel, or a viscous fluid. The muscarinic acetylcholine receptor antagonist may be a muscarinic acetylcholine receptor antagonist salt or a muscarinic acetylcholine receptor antagonist derivative or a muscarinic acetylcholine receptor antagonist analog.

Abstract: The present application includes a transdermal base formulation useful for example, for the transdermal delivery of active pharmaceutical ingredients along with a process for preparation thereof. In particular, the transdermal base formulation comprises: (a) an aqueous phase comprising water and at least one emulsion stabilizer; (b) an oil phase comprising at least one emulsifier, at least one emulsion stabilizer, at least one emollient comprising at least one flavonoid, at least one other emollient, and a terpene-rich natural butter; (c) an external phase comprising at least one terpene-rich extract or oil, at least one penetration enhancer and a phospholipid-complexed flavonoid; and optionally (d) at least one preservative phase.

Abstract: Provided herein are formulations effective for and methods of treating or preventing a neurodegenerative disorder in a subject in need thereof that can include administering an amount of an aPKC inhibitor to a subject in need thereof.

Abstract: Cannabidiol (CBD) is a cannabinoid designated chemically as 2-[(IR,6R)-3-Methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl]-5-pentyl-1,3-benzenediol. Its empirical formula is C21H30O2 and its molecular weight is 314.46. CBD is a cannabinoid that naturally occurs in the Cannabis sativa L. plant. CBD is a white to pale yellow crystalline solid which is insoluble in water and soluble in organic solvents. The present invention encompasses the surprising recognition that certain CBD preparations which are prepared from a botanical origin are more effective in treating diseases or disorders than preparations of CBD which are synthetic or purified to the extent no other impurities in the form of other cannabinoids are present. Prior CBD compositions have been prepared such that no psychoactive components, e.g., tetrahydrocannabinol (THC), remain in the final CBD preparation. Surprisingly, the absence of such minor impurities reduces the efficacy of CBD treatment.

Abstract: This application relates to solid forms and salt forms of the PD-1/PD-L1 inhibitor 4,4?-(((((2,2?-dichloro-[1,1?-biphenyl]-3,3?-diyl)bis(azanediyl))bis(carbonyl))bis(1-methyl-1,4,6,7-tetrahydro-5H-imidazo[4,5-c]pyridine-2,5-diyl))bis(ethane-2,1-diyl))bis(bicyclo[2.2.1]heptane-1-carboxylic acid), including processes of preparation thereof, where the solid forms and salt forms are useful in the treatment of various diseases including infectious diseases and cancer.

Abstract: The invention is based on the discovery that rho kinase inhibitors, particularly fasudil can be used to treat agitation/anxiety in dementia patients, particularly Alzheimer's disease patients. Fasudil treatment of Alzheimer's patients resulted in improvements in agitation that are orders of magnitude to that observed with other potential therapeutic agents.

Abstract: The disclosure is directed to formulations comprising cannabinoids. More particularly, the cannabinoid formulations can be designed to align with an individual's genotype based on a defined list of polymorphisms.

Abstract: Provided herein are compounds according to Formula (I) or a pharmaceutically acceptable salt thereof, wherein R1, R2, R3, R5, and R7 are defined herein. Also provided herein are pharmaceutical compositions comprising a compound of Formula (I) as well as the use of such compounds as M4 receptor agonists.