Abstract: The invention provides gastric residence systems for administration of adamantane-class drugs or pharmaceutically acceptable salts thereof, such as memantine or pharmaceutically acceptable salts thereof, and methods for making and using such systems. The systems provide extended release of drug, reducing the frequency with which the drug must be administered to the patient. The gastric residence systems, or components of gastric residence system such as segments or elongate members of gastric residence systems, can have release rate-modulating films, which provide good control over release of adamantane-class drugs or pharmaceutically acceptable salts thereof present in the gastric residence system. Some embodiments of the films can provide resistance against burst release of adamantane-class drugs or pharmaceutically acceptable salts thereof upon exposure to alcohol.

Abstract: A dosage form comprising a tablet core and one or more discontinuous coated regions in various configurations on the surface of the dosage form is disclosed. A method for making the dosage form is also disclosed.

Abstract: The presently disclosed subject matter relates to a composition and method of using the composition for oral delivery of a bioactive agent to a subject. More particularly, the presently disclosed subject matter relates to a composition comprising an effective amount of at least one bioactive agent layered over a substrate and a method of reducing zoonotic infectious disease by administering the composition to a subject. The presently disclosed subject matter further relates to a method of preparing the composition.

Abstract: Provided is a device for granulating, agglomerating, pelletising, drying and/or coating, the device including a swirl chamber, a distribution chamber, wherein the swirl chamber is separated from the distribution chamber by a base and wherein a powder to be granulated or a powder mixture to be granulated is presented in the swirl chamber, the device further including at least one agitator for thoroughly mixing the powder to be granulated or the powder mixture to be granulated and at least one addition device for a liquid, wherein the base is designed in several parts and at least one base part is horizontally and/or vertically displaceable, with the result that that the base becomes a distributor plate. Also provided is a method for granulating, agglomerating, pelletising, drying and/or coating using such a device and a base suitable for use as a distributor plate in a convective drying apparatus.

Abstract: The instant disclosure provides a capsule composition comprising pullulan, a setting system and a surfactant system that is a sucroglyceride or a sugar fatty acid ester, and methods for making such capsules.

Abstract: The disclosure provides cysteamine salt and cystamine formulations comprising enteric coatings. The disclosure also provides composition for use in treating diseases and disorders that can be treated with cysteamine.

Abstract: In some aspects, fusosome compositions and methods are described herein that comprise membrane enclosed preparations, comprising a fusogen. In some embodiments, the fusosome can the target cell, thereby delivering complex biologic agents to the target cell cytoplasm.

Abstract: Provided herein are methods and compositions for sensitizing a cancer cell to a cancer treatment, for example to an anticancer drug by the inhibition of at least two cancer biomarkers. Further provided are methods of treating and/or preventing a cancer including reducing the size of a tumor. Also provided are compositions comprising nanopartides associated with inhibitory molecules, such as siRNA, and/or anti-cancer drugs.

Abstract: The present invention relates to a transdermal therapeutic system for the transdermal administration of guanfacine comprising a guanfacine-containing layer structure, said guanfacine-containing layer structure comprising: A) a backing layer; and B) a guanfacine-containing layer; wherein the transdermal therapeutic system comprises at least one silicone polymer.

Abstract: The present invention relates to a composition comprising ethyl vanillin or a pharmaceutically acceptable salt thereof as an effective ingredient for preventing or treating muscle disease or for improving a muscle function. Having the capability of upregulating the expression of a protein associated with muscle protein synthesis and muscle mass increase in myocytes and downregulating at an mRNA level the expression of an enzyme involved in muscle protein degradation, ethyl vanillin can exhibit effects of muscle differentiation, muscle regeneration, and muscle strengthening through an increase in muscle mass against muscle diseases attributed to muscle function decrease, muscle consumption, or muscle degradation and can suppress sarcopenia. Thus, ethyl vanillin can be used for preventing or treating muscle diseases or for promoting muscle differentiation, muscle regeneration and muscle strengthening, muscle mass increase, or muscle generation or for improving muscle function.

Abstract: In an embodiment of the invention, a composition for treating a cell population comprises an Affinity Medicant Conjugate (AMC). The medicant moiety can be a toxin including an acylfulvene or a drug moiety. The affinity moiety can be an antibody, a binding protein, a steroid, a lipid, a growth factor, a protein, a peptide or non peptidic. The affinity moiety can be covalently bound to the medicant via a linker. Novel linkers that can be directed to cysteine, arginine or lysine residues based on solution pH allow greater flexibility in preserving and/or generating specific epitopes in the AMC.

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: Oral pharmaceutical solution comprising a pharmaceutically acceptable salt of lisdexamfetamine, and a pharmaceutically acceptable aqueous carrier comprising a buffer and a cosolvent selected from the group consisting of a glycol, a polyol, and a mixture thereof, wherein the pH of the solution is from 5.5 to 9.0. The oral pharmaceutical solution presents excellent physicochemical stability, even under alkaline conditions.

Abstract: Disclosed herein is a multidrug pain management package to dispense two or more medicaments to treat pain comprising a primary n-polygon, and one or more concentric m-polygons, wherein each side of the n-polygon and m-polygons have at least n or m-medicament chambers capable of holding the two or more medicaments. Also disclosed herein is a multidrug pain management package comprising a disk, wherein the disk is divided into equally spaced regions, and wherein each region has chambers capable of holding medicaments. Also disclosed herein are single formulations to treat pain.

Abstract: Disclosed are acidic feminine intimate cleansing compositions having a pH in the range of from 3 to 5, which further necessarily comprises at least: as a primary antimicrobial active constituent, lactic acid, which may optionally be a substituted lactic acid and/or derivative thereof; and which composition further includes an anionic constituent system which boosts the antimicrobial efficacy of the primary lactic acid constituent present; and which compositions feature low irritation, and good antimicrobial efficacy against certain species of bacteria. Treatment processes using the feminine intimate cleansing composition in treatment of the groin area of human females, and vendible products containing the feminine intimate cleansing compositions are also disclosed.

Abstract: The present specification provides RXR agonist compounds, compositions comprising such RXR agonists, and methods using such compounds and compositions to treat an autoimmune disorder, inflammation associated with an autoimmune disorder and/or a transplant rejection as well as use of such RXR agonists to manufacture a medicament and use of such compounds and compositions to treat an autoimmune disorder, inflammation associated with an autoimmune disorder and/or a transplant rejection.

Abstract: Antifibrinolytic agents/drugs are applied to the concussive area of a patient's brain to counter the activation of a fibrinolytic process in the concussive area. Various techniques are described for administering the antifibrinolytic agent.

Abstract: The present invention generally provides methods and compositions for the treatment of Parkinson's disease and depression and/or anxiety. The invention relates to recombinant microorganisms, particularly gut-colonizing probiotics, modified to produce L-DOPA.

Abstract: The present disclosure provides compositions and methods for promoting stem cell and/or progenitor cell proliferation and/or differentiation. The provided compositions may be useful in treating a disease or condition that is related to mucosal barrier function, e.g., wound healing, treating skin conditions (e.g., atopic dermatitis, psoriasis, bed sores, or condition related to the aging of skin), treating a lung disorders (e.g., asthma), a condition related to improving mucosal barrier function, and/or treating injury to GI mucosa in a subject in need thereof. The present disclosure also provides methods for promoting the proliferation and/or differentiation of stem cells and/or the progenitor cells in a subject in need of such treatment by administering a composition. The ability to stimulate the proliferation and/or differentiation of stem cells and/or the progenitor cells in vivo, ex vivo and/or in vitro provides tremendous benefit.

Abstract: Compositions and methods are provided for the alleviation of pathology induced by traumatic brain injury.

Abstract: The present invention relates to a construct comprising a C13 to C27 fatty acid non-covalently bound to a hydrophobic region of a carrier particle, methods of manufacture, and uses thereof.

Abstract: A construct comprising a dermal extracellular matrix gel, polymer fibers, and microparticles containing a nitro oleic acid agent.

Abstract: The present invention is directed to a method for treating cardiovascular diseases such as acute myocardial infarction, atherosclerosis, heart failure, stroke, thrombosis, carditis (including acute myocarditis, acute pericarditis and complicated pericarditis), cardiac allograft rejection, cardiomyopathy, and peripheral vascular diseases. The method comprises administering to a subject in need thereof dapansutrile, in an effective amount. A preferred route of administration is oral administration.

Abstract: The present disclosure provides methods of identifying patients who have partial or total resistance to HIF-2 inhibitors or who develop partial or total resistance to HIF-2 inhibitors after treatment and providing suitable treatment to these patients.

Abstract: The subject matter disclosed herein relates to rofecoxib, also known as TRM-201 or RXB-201, its method of manufacture, and use. In certain aspects, the highly pure or substantially pure rofecoxib as provided herein has a favorable purity profile and is the active ingredient in a pharmaceutical composition that is administered to treat or prevent a number of conditions, including pain associated with a condition caused by a bleeding disorder.

Abstract: Methods for treating or reducing the likelihood of acquiring estrogen-related (e.g. estrogen-exacerbated) diseases including endometriosis include administering to a patient a selective estrogen receptor modulator (SERM), in combination with inhibiting ovarian secretions, e.g., by administering an LHRH agonist or antagonist. In some embodiments, a precursor of sex steroids, said precursor being selected from the group consisting of dehydroepiandrosterone (DHEA), dehydroepiandrosterone sulfate (DHEA-S), androst-5-ene-3?,17?-diol (5 diol), and androstenedione or a compound transformed into one of these, is also administered.

Abstract: The present disclosure provides for compounds useful for the treatment or prevention of disorders with an etiology associated with or comprising excessive cytokine or chemokine release. The compounds are also useful for the treatment of cancer, inflammatory disorders and disorders associated with an increased stability or translation of mRNA which has an mRNA instability sequence.

Abstract: The present invention relates to pharmaceutical compositions comprising the selective beta 1 (B1)-receptor blocker nebivolol and/or a pharmaceutically acceptable salt thereof and a liquid vehicle comprising a semifluorinated alkane. The pharmaceutical composition of the present invention is useful for topical administration, for example ophthalmic topical administration and for use in the treatment of glaucoma, increased intraocular pressure, ocular hypertension and/or a symptom associated therewith.

Abstract: The present invention is directed to co-therapy and methods for the treatment and prevention of glucose-related disorders such as Type 2 diabetes mellitus and Syndrome X. The present invention is further directed to pharmaceutical compositions for the co-therapy and methods described herein.

Abstract: The invention provides compositions and methods for intravenous administration of 2-bromo-1-(3,3-dinitroazetidin-1-yl)ethanone (ABDNAZ), including formulations containing autologous whole blood and ABDNAZ that can be rapidly administered to a patient by intravenous infusion without any significant pain at the site of infusion.

Abstract: The present disclosure relates to benzoselenophene-based compounds, method of preparing the benzoselenophene-based compounds, pharmaceutical compositions and antibody-drug conjugates including the benzoselenophene-based compounds.

Abstract: The purpose of the present invention is to provide: a therapeutic agent or a recurrence preventive agent for serotonergic system- or dopaminergic system-related diseases, in particular, mental dysfunction symptoms and other non-motor symptoms of Parkinson's disease; and a method for treating the aforesaid symptoms or preventing the recurrence of the same. A compound represented by formula (1) [wherein each symbol is as defined in the description] or a pharmaceutically acceptable salt thereof can exhibit an effect of treating serotonergic system- or dopaminergic system-related diseases, in particular, mental dysfunction symptoms and other non-motor symptoms of Parkinson's disease and/or an effect of preventing the recurrence of the same.

Abstract: The present invention relates to a novel formulation comprising a benzimidazole derivative. The formulation for oral administration comprising a compound of Formula 1 according to the present invention or a pharmaceutically acceptable salt thereof; and at least one disintegrant selected from the group consisting of croscarmellose sodium, sodium starch glycolate and low-substituted hydroxypropylcellulose, exhibits an excellent storage stability and has an effect on preventing a phenomenon of decline in dissolution rate, thus being usefully used as a formulation for oral administration.

Abstract: There is provided tinostamustine or a pharmaceutically acceptable salt thereof for use in the treatment of sarcomain a patient in need thereof.

Abstract: A method of lowering cholesterol and/or PCSK9 levels in a subject in need thereof includes administering to the subject an ADH inhibitor, AKR inhibitor, and/or SNO-CoAR inhibitor at an amount(s) effective to reduce serum cholesterol and/or PCSK9 levels.

Abstract: A method effective in treating a viral infection involves administering a therapeutically effective amount of at least one compound capable of inhibiting expression of at least a portion of a virus genome containing an internal ribosomal entry site, or a pharmaceutically acceptable salt thereof. The compound has an azole moiety comprising a five member heterocyclic ring containing at least one nitrogen atom, a hydrophobic moiety bonded to the heterocyclic ring of the azole, and a donor/acceptor moiety bonded to the heterocyclic ring having at least one of hydrogen bond donor and a hydrogen bond acceptor.

Abstract: The treatment of human subjects suffering from COVID-19 comprises the step of administering to the human subjects a medicament selected from the group consisting of 1,3-bis(7-methoxy-4,9-dihydro-3H-pyrido[3,4-b]indol-1-yl)propane, and/or the isomers, tautomers, enantiomers, esters, derivatives, metal complexes, prodrugs, solvates, metabolites, and pharmaceutically acceptable salts thereof. The medicament may also be contacted with SARS-CoV-2 virus for inhibition of the virus.

Abstract: Provided herein is an amorphous compound represented by Formula (I): and compositions thereof, which are useful in the treatment of disorders related to the activity of the c-KIT and PDGFR? kinases, and oncogenic forms thereof.

Abstract: The present disclosure relates to methods of treating gastrointestinal stromal tumors to a subject in need thereof, comprising administering to the subject a therapeutically effective amount of ripretinib or a pharmaceutically acceptable salt thereof.

Abstract: The invention provides topical pharmaceutical gel compositions for the treatment of chronic skin damage, specifically for damage caused by neuropathic ulcers and preferably for the treatment of diabetic foot, and in the treatment of vascular ulcers wherein said compositions comprise a combination of Modified Diallyl Disulfide Oxide (M-DDO) (as an antiseptic/antibiotic agent) and 5-methyl-1-phenyl-2(1H)-pyridone. Furthermore, the invention describes methods of treatment, applications and/or pharmaceutical uses in the preparation of medicaments for eliminating, reducing or preventing chronic skin lesions and the damages caused by neuropathic ulcers and particularly in the treatment of diabetic foot and in the treatment of vascular ulcers.

Abstract: Methods of treating patients diagnosed with cancer harboring an IDH-1 mutation are provided, including the therapeutic administration of a certain inhibitor of a mutant IDH-1 as a single agent, or in combination with azacitidine (AZA).

Abstract: The present invention provides heteroaryl ketone fused azadecalin compounds and methods of using the compounds as glucocorticoid receptor modulators.

Abstract: The present invention relates to compositions and methods for the treatment of the Charcot-Marie-Tooth disease and related disorders.

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: Provided herein are methods of treating a subject with heart failure, comprising administering to the subject an initial dose of a cardiac sarcomere activator (CSA) for an initial time period, and subsequently administering to the subject a dose of the CSA based on the subject's plasma concentration of the CSA at the end of the initial time period.

Abstract: This application relates to combination compositions for use in treatment of depression, and which can alleviate the anxiogenic side effects of certain antidepressant and antipsychotic medications. Methods for treatment of depression and medicament side effects, particular anxiety, akathisia, and associated suicidality are also described herein.

Abstract: Methods are provided for treating a subject having a MYC-driven neoplasia. Aspects of the methods include administering to the subject an amount of an inhibitor of a target gene effective to treat the subject for the MYC-driven neoplasia. Methods are also provided for identifying a MYC-dependent target gene in a MYC-driven neoplasia. Aspects of the method include identifying the MYC-dependent target gene based on a phenotype detected in a first tumor cell line conditionally expressing MYC that is absent or quantitatively different in a second tumor cell line conditionally repressing MYC when the two cell lines are contacted with a CRISPR-based gene silencing agent. Kits and cell lines for practicing the methods of the disclosure are also provided.

Abstract: The disclosure relates to methods for treating or preventing an Insomnia Disorder by administering to a human in need thereof a compound of formula (I), or a compound of formula (IA), (IB), or (IC), or a solvate thereof, in a daily dose of from about 0.5 mg to about 6.0 mg. In certain embodiments, such compounds effectively treat or prevent an Insomnia Disorder in the animal, while producing reduced side effects compared to previously available compounds.

Abstract: Provided is a medicament or a method for treating or preventing a corneal endothelial condition, disorder or disease due to a transforming growth factor-? (TGF-?) signal in corneal endothelial cells using a p38 MAP kinase inhibitor (in particular AKP-001), such as a pyrimidinyl isoxazole derivative or a pyridyl isoxazole derivative. In a preferred embodiment, the corneal endothelial condition, disorder or disease due to the TGF-? signal is Fuchs' corneal endothelial dystrophy.

Abstract: There is a method of treating or preventing pulmonary arterial hypertension (PAH) or associated pulmonary arterial hypertension (APAH) in a patient. The method has the step of systemically administering to the patient a therapeutically effective amount of one or more compounds: (S)-ethyl 8-(2-amino-6-((R)-1-(5-chloro-[1,1?-biphenyl]-2-yl)-2,2,2-trifluoroethoxy)pyrimidin-4-yl)-2,8-diazaspiro[4.5]decane-3-carboxylate or a pharmaceutically acceptable salt thereof, or (S)-8-(2-amino-6-((R)-1-(5-chloro-[1,1?-biphenyl]-2-yl)-2,2,2-trifluoroeth-oxy)pyrimidin-4-yl)-2,8-diazaspiro[4.5]decane-3-carboxylic acid or a pharmaceutically acceptable salt thereof, or a combination of the foregoing. There is also a method of treating or preventing PAH or APAH in a patient by systemically administering a therapeutically effective amount of a THP1 inhibitor from about 1 mg/kg/day to about 50 mg/kg/day. There is a method for treating PAH or APAH in a patient with a single daily dose.