Abstract: The invention provides a pharmaceutical composition comprising sodium lauryl sulfate, hydroxypropyl methylcellulose (HPMC), a copolymer of vinylpyrrolidone and vinyl acetate, and a therapeutically effective amount of metaxalone or a pharmaceutically acceptable salt thereof. Related processes and methods are also disclosed.

Abstract: This invention describes the use of indane acetic acid derivatives which are dual PPAR delta/gamma agonists, and which penetrate the Blood Brain Barrier and achieve effective brain to plasma drug levels at non-toxic doses, for the treatment of neurodegenerative diseases including one or more of the following: Alzheimer's Disease (AD); Huntington's Disease (HD); Parkinson's Disease (PD); Amyotrophic Lateral Sclerosis (ALS); Frontal Temporal Dementia (FTD); Corticobasal Degeneration (CBD); Progressive Supranuclear Palsey (PSP); Dementia with Lewy Bodies (DLB); or Multiple Sclerosis (MS).

Abstract: The present invention is based on the finding that CD11b signaling inhibits immune suppression, modulates neovascularization and promotes anti-tumor immune responses in models of murine and human cancer. As such, provided herein are methods of treating cancer using an antibody, protein or small molecule that modulates CD11b activity or expression. Also provided are methods of identifying cancer that is amenable to such treatment and/or increasing susceptibility of cancer cells to treatment with a chemotherapeutic agent.

Abstract: Described herein are combinations of compounds effective for activation of Tie-2 and inhibition of HPTP? with a compound that causes agonism of a prostaglandin receptor. The methods and compositions of the invention can be used for the treatment of glaucoma, elevated intraocular pressure, ocular hypertension, and associated conditions by, for example, reduction of intraocular pressure in the eye.

Abstract: Disclosed are methods of treating Alzheimer's Disease by administering to a patient in need thereof a riluzole prodrug such as troriluzole. Pharmaceutical compositions and kits including the riluzole prodrugs are also disclosed.

Abstract: Use of allosteric modulators and/or gaboxadol for the treatment of epileptic disorders in a subject in need thereof.

Abstract: The present disclosure relates to methods of treating or preventing a sleep breathing disorder. More specifically, the disclosure relates to a method of treating or preventing sleep apnea comprising the use of a KCNQ potassium channel opener.

Abstract: The present invention provides a non-coating topical therapeutic agent for tinea unguium containing medium-chain triglyceride and the like as non-volatile components, which agent has high nail permeability and is superior in the aspects of efficacy and preparation properties, and can be applied clinically. Particularly, the present invention provides a topical therapeutic agent for tinea unguium containing an antifungal active substance such as efinaconazole or the like, a volatile component, an additive such as medium-chain triglyceride or the like, and a permeation enhancer such as ethyl lactate and the like. The preparation shows remarkably improved nail permeability has superior properties as a pharmaceutical product from the aspects of efficacy and preparation properties.

Abstract: A therapeutic composition for topical delivery of a metalloporphyrin to the hoof region of an equine leg suffering from laminitis is provided. Also provided is a method of reducing the degree of an injury to the hoof of an equine that is the result of laminitis. The method results in a reduced period for recovery and reduces the possibility of euthanasia of the animal.

Abstract: A compound of formula (I), or a pharmaceutically acceptable salt thereof.

Abstract: Compounds of formula (I), wherein A, W, R3b, Z and p have the meaning according to the claims, can be employed, inter alia, for the treatment of tauopathies and Alzheimer's disease.

Abstract: Described herein are methods of treating or preventing an ASK1 or DYRK1A associated disease, disorder, or condition comprising administering to a subject in need thereof a dual inhibitor of ASK1 and DYRK1A; including administering pharmaceutically acceptable salts and solvates thereof.

Abstract: An oral methylphenidate extended release tablet is described, which can be scored and still retain its extended release profile. The tablet contains a combination of an uncoated methylphenidate—ion exchange resin complex, a barrier coated methylphenidate—ion exchange resin complex—matrix, and an uncomplexed methylphenidate active component. Following administration of a single dose of the extended release methylphenidate chewable tablet, a therapeutically effective amount of methylphenidate is reached in less than about 20 minutes and the composition provides a twelve-hour extended release profile.

Abstract: Provided herein is an ophthalmic composition. In some embodiments, the ophthalmic composition includes a low concentration of an ophthalmic agent for treatment of an ophthalmic disorder or condition; and an ophthalmically acceptable carrier, wherein the ophthalmic agent is distributed with substantial uniformity throughout the ophthalmically acceptable carrier. Further disclosed herein include an ophthalmic composition including a low concentration of an ophthalmic agent and deuterated water. Also disclosed herein are methods of arresting or preventing myopia development by administering to an eye of an individual in need thereof an effective amount of an ophthalmic composition as described herein.

Abstract: In certain embodiments, the present disclosure is directed to methods for treating pain in a subject, such as a human, wherein the methods comprise orally administering a therapeutically effective amount of N-[4-(6-fluoro-3,4-dihydro-1H-isoquinolin-2-yl)-2,6-dimethylphenyl]-3,3-dimethylbutanamide (Compound A), to the subject in need thereof. The present disclosure is further directed to various improved methods of therapy and administration of Compound A.

Abstract: The present disclosure relates to a method of loading a toll like receptor (TLR)7/8 agonist into a liposome using remote loading and a kit of parts suitable for the loading of a TLR7/8 agonist into a liposome by said method. The present disclosure further relates to a liposome comprising a salt of a TLR7/8 agonist in the liposome interior and to the use of said liposome for stimulation of an immune response and/or treatment of a clinical condition. Finally, the present disclosure relates to a TLR7/8 agonist which is suitable for being remotely loaded into a liposome.

Abstract: The disclosures herein relate to novel compounds of formula wherein R1, R2, R3 and R4 are as defined herein, and their use in treating, preventing, ameliorating, controlling or reducing cerebrovascular or vascular disorders associated with CGRP receptor function.

Abstract: Provided herein are pharmaceutical combinations, compositions, and methods of using a compound with estrogen receptor (ER) degradation activity, such as a compound of formula (I) or a tautomer, stereoisomer or a mixture of stereoisomers, or a pharmaceutically acceptable salt, or hydrate thereof, wherein R1, Y, R22, R33, R2, p, X3, X4, and Z are defined herein and a cyclin-dependent kinase (CDK) inhibitor.

Abstract: The present disclosure provides inhibitors of one or more subunits of polycomb repressive complex 2 (PRC2) for use in the prevention or the treatment of an eye disorder in a subject in need thereof and methods for treating an eye disorder, e.g. non-cancer disorders, in a subject using a therapeutically effective amount of one or more inhibitors of a subunit of polycomb repressive complex 2 (PRC2). In certain embodiments of the methods of the disclosure, the eye disorders are characterized by degeneration or cell death of retinal neurons. In certain embodiments of the methods of the disclosure, the subunit of PRC2 is EZH1 or EZH2, and the inhibitor is an inhibitor of H3K27 trimethylation.

Abstract: The present disclosure relates to methods and compositions for treating immune-mediated diseases. In some aspects, the disclosure relates to methods for treating immune-mediated diseases by administering an EHMT2 inhibitor in combination with one or more treatment modalities (e.g. one or more therapeutic agents). In some aspects the immune-mediated disease is rheumatoid arthritis, multiple sclerosis, psoriasis, a psoriatic disorder, psoriatic arthritis, or an inflammatory bowel disease.

Abstract: The present invention concerns pharmaceutical compositions formulated for topical application that are useful in the treatment of HPV-related pathologies and in particular the treatment of premalignant and malignant conditions of the cervix. The compositions comprise a therapeutically effective amount of lopinavir and ritonavir in a pharmaceutically acceptable vehicle and wherein the weight ratio (w/w) of lopinavir: ritonavir is between 9:1 and 18:1.

Abstract: The present invention concerns pharmaceutical compositions formulated for dermal application comprising a therapeutically effective amount of lopinavir and ritonavir in a pharmaceutically acceptable vehicle and wherein the weight ratio (w/w) of lopinavir: ritonavir is between 9:1 and 18:1. Such compositions are useful for treating, or preventing, skin cancers and premalignant dermal conditions.

Abstract: Methods of treating or slowing the growth of a lesion associated with geographic atrophy and methods of evaluating a drug or agent for use in treating, reducing the progression of or slowing the growth of a lesion associated with geographic atrophy.

Abstract: The disclosure provides the administration of inhibitors of phosphodiesterase 1 (PDE1) for the treatment and prophylaxis of diseases or disorders characterized by inflammation, e.g., neuroinflammation, including methods of treatment and pharmaceutical compositions for use therein.

Abstract: The disclosure relates generally to gamma polyglutamated aminopterin compositions, including delivery vehicles such as liposomes containing the gamma polyglutamated aminopterin, and methods of making and using the gamma polyglutamated aminopterin compositions to treat hyperproliferative disorders (e.g., cancer) and disorders of the immune system (e.g., inflammation and autoimmune diseases such as rheumatoid arthritis).

Abstract: Disclosed are methods and pharmaceutical compositions for treating cancer. It was hypothesized that low activity of serine hydroxymethyl transferase (SHMT) due to poor pyridoxal 5?-phosphate (PLP) availability within cancer cells would result in insufficient growth inhibition in cancer cells exposed to 5-fluorouracil (FUra), as well as to FUra in combination with N5-formyl tetra hydro pteroylglutamate (5-HCO—H4PteGlu; folinic acid). Cancer cell lines were exposed to FUra as a single agent and to FUra with folinic acid, in combination with high concentration PLP. There was demonstrated synergistic and additive interactions upon cytotoxicity of FUra by folinic acid and PLP combined in HT29, HCT116, and L1210 cancer cells. Murine studies of parenteral administration of pyridoxamine or pyridoxine in high doses showed that intracellular PLP is augmented to levels close or greater than the Kd reported for binding of cofactor to SHMT, suggesting modulation of the fluoropyrimidines by vitamin B6 was possible.

Abstract: Compositions and methods for treating hair loss and/or nail brittleness, fragility, and pitting, particularly in pediatric patients, using topically administered JAK/STAT inhibitors and one or more penetration enhancer are described herein.

Abstract: This invention is in the area of improved compounds for and methods of treating selected RB-positive cancers and other Rb-positive abnormal cellular proliferative disorders while minimizing the deleterious effects on healthy cells, for example healthy Hematopoietic Stem Cells and Progenitor Cells (HSPCs), associated with current treatment modalities. In one aspect, improved treatment of select RB-positive cancers is disclosed using specific compounds disclosed herein. In certain embodiments, the compounds described herein act as highly selective and, in certain embodiments, short, transiently-acting cyclin-dependent kinase 4/6 (CDK 4/6) inhibitors when administered to subjects.

Abstract: The present invention provides prodrugs and methods of use thereof.

Abstract: Liquid dosage forms of Aprepitant are not much explored. The present invention describes ready to use, oral liquid compositions of Aprepitant suitable for the patients having swallowing difficulties. The liquid compositions of the present invention are storage stable for prolonged time and can be used for the prevention and control of acute and delayed chemotherapy induced nausea and vomiting, and for the prevention of postoperative nausea and vomiting.

Abstract: Disclosed are pharmaceutical salts and co-crystals of pentoxifylline, clonidine and linsidomine with caffeic acid, protocatechuic acid or ?-lipoic acid, and method for preparing thereof. Also disclosed are topical compositions comprising said salts or co-crystals and use thereof for treating pain.

Abstract: The present invention provides new methods of treatment for narcolepsy, excessive daytime sleepiness, obstructive sleep apnea, circadian rhythm sleep disorders, sleep and vigilance disorders associated with Parkinson's disease, multiple sclerosis, dementia or attention deficit hyperactivity disorder by administering a therapeutically effect amount of histamine-3 receptor (H3R) inverse agonist, N-[4-(1-Cyclobutylpiperidin-4-yloxy)phenyl]-2-(morpholin-4-yl)acetamide or a pharmaceutically acceptable salt thereof. The present invention further provides use of the said compounds in the manufacture of medicament intended for the treatment of the disorders described herein.

Abstract: The present disclosure relates to pharmaceutical compositions comprising inhibitor(s) of human histone methyltransferase EZH2, and methods of cancer therapy using the EZH2 inhibitor(s).

Abstract: Unit dosage forms of meloxicam containing either 5 mg or 10 mg of meloxicam that provide effective pain relief and have desirable pharmacokinetic properties are described. The unit dosage forms can provide pain relief when a single unit dose is administered to a patient and useful for treating pain such as osteoarthritis pain at a relatively low systemic exposure to meloxicam.

Abstract: Medicaments for use in treating acute myelogenous leukemia, chronic myelogenous leukemia, breast cancer, ovarian cancer, malignant melanoma, lung cancer, pancreatic cancer, glioblastoma, sarcoma, desmoid tumors, adenoid cystic carcinoma (ACC), colorectal cancer, prostate cancer, or medulloblastoma in a patient by administering simultaneously, separately, or sequentially, 4,4,4-trifluoro-N-[(IS)-2-[[(7S)-5-(2-hydroxyethyl)-6-oxo-7H-pyrido[2,3-d][3]benzazepin-7-yl]amino]-1-methyl-2-oxo-ethyl]butanamide, or a pharmaceutically acceptable salt or hydrate thereof, and N-[5-(4-ethyl-piperazin-1-ylmethyl)-pyridin-2-yl]-[5-fluoro-4-(7-fluoro-3-isopropyl-2-methyl-3H-benzoimidazol-5-yl)-pyrimidin-2-yl]-amine, or a pharmaceutically acceptable salt thereof.

Abstract: The invention is based on the discovery that rho kinase inhibitors can be used to treat certain dementia-associated wandering. The inventive methods relate to the use of rho kinase inhibitors in the treatment of patients with cortical dementia-associated wandering. Preferred aspects of the invention contemplate treating wandering due to cortical vascular dementia and wandering due to dementia where the patient is a persistent wanderer and/or where the patient does not display a wayfinding defect.

Abstract: Methods and compositions for treating cyanide, sulfide, or methane-thiol exposure in a subject. The compositions may include one or more cobinamide compounds, such as an amino-tetrazole-cobinamide and/or a di-(amino-tetrazole)-cobinamide.

Abstract: Described herein are compositions comprising a prostaglandin FP receptor agonist (PFPRA) compound and a fatty acid, e.g., oleic acid, that, when topically applied to the skin, locally delivers a therapeutically effective amount of the PFPRA compound or active metabolite thereof to subcutaneous fat under the skin. The therapeutic effect is, for example, reduction of the subcutaneous fat under the skin. Further provided are methods of reducing body fat in a subject comprising topically administering the composition to the subject. The present invention also provides kits comprising the composition and instructions for use.

Abstract: Provided are methods for slowing, halting, and reversing gray matter atrophy and progression of disability in certain neurodegenerative diseases, including multiple sclerosis, using estrogen, alone or in combination with another agent.

Abstract: A combination composition including as active components, in synergistically effective amounts of (i) a steroidal saponin of natural or synthetic origin, a pharmaceutical acceptable salt thereof or a plant extract containing steroidal saponin, and (ii) at least a first polyphenolic compound selected from the group of hydroxycinnamic acids, flavonoids, hydroxybenzoic acids, and (iii) optionally, a second polyphenolic compound, wherein the second polyphenolic compound is hydroxycinnamic acids and its use in preventing, inhibiting, retarding or treating a subject suffering from a neurodegenerative disease or condition.

Abstract: Described herein are synthetic progestogens, such as 6?,7?:15?,16?-Dimethylene-3-oxo-17?-pregn-4-ene-21,17-carbolactone, as well as pharmaceutical compositions comprising the same. Also described are methods of use.

Abstract: The disclosure relates to compounds of formula (I): R1-NH—CH(R2)-P(?O)(OH)—CH2-C(R3)(R4)-CONH—C(R5)(R6)-COOR7, where R1 to R7 are as defined in the claims, for use of same in the treatment and/or prevention of ocular inflammation, and more particularly for improving the process of ocular healing. Thus, the compounds of formula (I) are used, in particular, to prevent neovascularisation, or to prevent or treat an ocular inflammation linked to a keratitis, scleritis, episcleritis, uveitis, cataract, synechia, macular oedema, detachment of the retina, ocular hypertension and degeneration of the optical nerve caused by glaucoma.

Abstract: Some embodiments of the invention include methods for treating an animal for fibrosis comprising one or more administrations of one or more compositions comprising one or more AURKB (Aurora kinase B) inhibitors. Other embodiments of the methods for treating further include other fibrosis treatments. Still other embodiments of the invention include methods for treating a human for lung fibrosis or idiopathic pulmonary fibrosis, comprising administering one or more compositions comprising AZD1152 or barasertib. Additional embodiments of the invention are also discussed herein.

Abstract: The invention relates to a method, compounds and compositions for the secondary prevention, treatment or dietary management of symptomatic and asymptomatic non-intestinal autoimmune diseases in a non-infant human including Sjogren's syndrome and type 1 diabetes. Said method, compounds and compositions for the secondary prevention, treatment or dietary management include human milk oligosaccharide (HMO), preferably mixtures of human milk oligosaccharides selected from the group of 2?-FL, LNnT, LNT, DFL, and 6?-SL.

Abstract: The invention relates to a composition containing as active agent ectoine, hydroxyectoine, glucosylglycerol and/or salts, esters or amides of these compounds for promoting the regeneration of injured body tissue. The invention has special significance for the treatment of chronic wounds or ulcers.

Abstract: An object of the present invention is to provide a combination drug containing cytarabine and a DHODH inhibitor, as a new anti-tumor agent, and to provide an anti-tumor effect enhancing agent which is used in combination with cytarabine, an anti-tumor kit, and an anti-tumor agent which is used in combination with cytarabine. According to the present invention, an anti-tumor agent and an anti-tumor kit containing cytarabine and a dihydroorotate dehydrogenase inhibitor compound are provided.

Abstract: Methods for predicting response to immunotherapy and selecting immunotherapy for treating cancer, e.g., cancer of epithelial origin, in a subject.

Abstract: The present invention provides novel compounds that target thrombocyte activity or aggregation capacity through cellular components for the treatment of diseases associated with Non-Alcoholic Fatty Liver Disease (NAFLD). The invention provides these compounds for treating non-alcoholic steatohepatitis (NASH), a progressed stage of NAFL (non-alcoholic fatty liver), in order to avoid the development of liver cirrhosis and Hepatocellular Carcinoma (HCC). Further provided are pharmaceutical compositions, comprising the compounds of the invention, and methods for screening new NASH therapeuticals.

Abstract: A method of treating a subject having a musculoskeletal disorder includes administering to a subject's articular site in need thereof an effective amount of a hyaluronic acid (HA) composition. In one embodiment, the HA composition includes an HA derivative, wherein carboxyl functionalities of the hyaluronic acid derivative are each independently derivatized to include an N-acylurea or O-acyl isourea, or both N-acylurea and O-acyl isourea. In another embodiment, the HA composition includes a crosslinked HA gel that is prepared by reacting an uncrosslinked HA with a biscarbodiimide in the presence of pH buffer in a range of between about 4 and about 8. The composite can optionally include at least one second bioactive agent other than the HA derivative, such as a steroid.

Abstract: Provided herein are compositions comprising ixabepilone, or a pharmaceutically acceptable salt thereof, and a copolymer represented by formula I: Also provided are methods of treating cancer using the compositions described herein, and methods of preparing the compositions.