Abstract: The present invention relates to methods for treating a disease associated with insulin resistance selected from a nonalcoholic fatty liver disease (NAFLD) and its sequelae, a lipodystrophic syndrome or a combination thereof with the selective PPAR? agonist, INT131 and optionally vitamin E or compositions thereof. NAFLDs that may be treated with methods and compositions of the present invention include, but are not limited to, simple nonalcoholic fatty liver and nonalcoholic steatohepatitis (NASH). Lipodystrophic syndromes that may be treated with the methods and compositions of the present invention include, but are not limited to, generalized lipodystrophy including congenital generalized lipodystrophy and acquired generalized lipodystrophy and/or partial lipodystrophy, including congenital partial lipodystrophy and acquired partial lipodystrophy, all of which may or may not include hyperlipidemia and/or hyperglycemia and may or may not include NAFLD.

Abstract: This disclosure relates to methods administering various compounds in conjunction with dextromethorphan to a human being.

Abstract: This disclosure relates to methods administering various compounds in conjunction with dextromethorphan to a human being.

Abstract: 8?-Hydroxy-Dihydroergotamine (8?-OH DHE) medicinal compounds, compositions, and dosage forms containing such compositions are provided. Also provided herein are methods of treatment, prevention, or amelioration of migraine disorders using the compounds, compositions, dosage forms and administration techniques disclosed herein.

Abstract: A pharmaceutical composition of bupropion or salts thereof and naltrexone or salts thereof is provided. The composition comprises bupropion and naltrexone in a single matrix core. The two active ingredients are not physically separated and neither represents a separate layer. A method of manufacturing the composition is also provided.

Abstract: Disclosed in certain embodiments is an oral dosage form comprising: a therapeutically effective amount of an opioid analgesic; an opioid antagonist; and an irritant in an effective amount to impart an irritating sensation to an abuser upon administration of the dosage form after tampering.

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

Abstract: The present invention relates to a formulation comprising an opioid, a Na channel blocker, an alpha2-receptor agonist, an opioid mu or delta receptor competitive antagonist and an intravenous anesthetic and/or a neurologic acting agent for use in pain control and/or cognitive function improvement.

Abstract: Abuse-resistant, controlled release opioid tablets are a combination containing an opioid antagonist such as naloxone at a level above that needed to suppress the euphoric effect of the opioid, if the combination were crushed to break the controlled release properties causing the opioid and opioid antagonist to be released as a immediate release product as a single dose. The controlled release nature of the table prevents the accumulation of orally effective amounts of opioid antagonist when taken normally. The opioid antagonist is contained in a controlled-release matrix and released, over time, with the opioid.

Abstract: An extended release composition for an analgesic active pharmaceutical ingredient which may be an opioid, preferably hydrocodone as the only active ingredient. The extended release composition preferably comprises a extended release composition which may be in the form of beads contained in an oral dosage form such as gelatin capsules. The composition is designed to release hydrocodone in a way such that the increase in hydrocodone exposure in hepatically impaired patients is not clinically significant. The oral dosage units are supplied as part of a kit, which also includes a primary package and a package insert all sold as a commercially marketed product.

Abstract: Provided herein are methods, compositions, and kits for Nr2 inhibitors and their use in treatment of mycobacterial infection and in combination therapy with known antitubercular drugs.

Abstract: The present invention is directed to compounds and pharmaceutically acceptable salts thereof which are inhibitors of the activity or function of the phosphoinositide 3?OH kinase family (hereinafter PI3K) for use in the treatment or prevention of respiratory infections, the treatment of airway damage, and/or the prevention of airway injury in patients.

Abstract: A treatment of patients afflicted with Amyotrophic Lateral Sclerosis (ALS), wherein the patients are treated with a tyrosine kinase inhibitor, mast cell inhibitor or c-Kit inhibitor, in particular masitinib, optionally in combination with at least one pharmaceutically active ingredient

Abstract: The present invention relates to pharmaceutical compositions comprising a compound of Formula (I) that are useful for the intramuscular delivery of antipsychotic drugs using rapid injection rates.

Abstract: Methods for treating cough, chronic cough and urges to cough associated with respiratory diseases with a P2X3 and/or a P2X2/3 receptor antagonist, the methods comprising administering to a subject in need thereof an effective amount of a compound of Formula (I): or a pharmaceutically acceptable salt thereof, wherein R1 and R2 are as defined herein.

Abstract: The invention provides a novel class of compounds, pharmaceutical compositions comprising such compounds and methods of using such compounds to treat or prevent diseases or disorders associated with abnormal or deregulated kinase activity, particularly diseases or disorders that involve abnormal activation of B-Raf.

Abstract: The present disclosure relates to compositions and methods for treating retinal damage and/or retinal degradation. More specifically, this disclosure relates to methods for treating degradation of the retinal pigment epithelium by administering compositions comprising a nucleoside and/or a nucleoside or nucleotide reverse transcriptase inhibitor.

Abstract: The invention relates to spiro derivatives, to the use of said derivatives intreating diseases and conditions mediated by modulation of voltage-gated sodium channels, to compositions containing said derivatives and processes for their preparation.

Abstract: The present invention relates to a method of treating cancer in a human and to pharmaceutical combinations useful in such treatment. In particular, the method relates to a cancer treatment method that includes administering 2-[(5-Chloro-2-{[3-methyl-1-(1-methylethyl)-1H-pyrazol-5-yl]amino}-4-pyridinyl)amino]-N-(methyloxy)benzamide, or a pharmaceutically acceptable salt thereof, and N-{3-[3-cyclopropyl-5-(2-fluoro-4-iodo-phenylamino)6,8-dimethyl-2,4,7-trioxo-3,4,6,7-tetrahydro-2H-pyrido[4,3-d]pyrimidin-1-yl]phenyl}acetamide, or a pharmaceutically acceptable salt or solvate thereof, to a human in need thereof.

Abstract: The present invention provides small molecule inhibitors of BMP signaling. These compounds may be used to reduce circulating levels of ApoB-100 or LDL. These compounds may also be used to treat or prevent acquired or congenital hypercholesterolemia or hyperlipoproteinemia; diseases, disorders, or syndromes associated with defects in lipid absorption or metabolism; or diseases, disorders, or syndromes caused by hyperlipidemia.

Abstract: Disclosed are pharmaceutical compositions and methods for treating or preventing muscle diseases or the symptoms thereof. The compositions typically include and the methods typically utilize phosphodiesterase type 5A inhibitors.

Abstract: The present invention generally relates to the transdermal delivery of various compounds. In some aspects, transdermal delivery may be facilitated by the use of a hostile biophysical environment. One set of embodiments provides a composition for topical delivery comprising a phosphodiesterase type 5 inhibitor and/or a salt thereof, and optionally, a hostile biophysical environment and/or a nitric oxide donor. In some cases, the composition may be stabilized using a combination of a stabilization polymer (such as xanthan gum, KELTROL® BT and/or KELTROL® RD), propylene glycol, and a polysorbate surfactant such as Polysorbate 20, which combination unexpectedly provides temperature stability to the composition, e.g., at elevated temperatures such as at least 40° C. (at least about 104° F.), as compared to compositions lacking one or more of these.

Abstract: The present invention generally relates to the transdermal delivery of various compounds. In some aspects, transdermal delivery may be facilitated by the use of a hostile biophysical environment. One set of embodiments provides a composition for topical delivery comprising a phosphodiesterase type 5 inhibitor and/or a salt thereof, and optionally, a hostile biophysical environment and/or a nitric oxide donor. In some cases, the composition may be stabilized using a combination of a stabilization polymer (such as xanthan gum, KELTROL® BT and/or KELTROL® RD), propylene glycol, and a polysorbate surfactant such as Polysorbate 20, which combination unexpectedly provides temperature stability to the composition, e.g., at elevated temperatures such as at least 40° C. (at least about 104° F.), as compared to compositions lacking one or more of these.

Abstract: A spray-dried powder formulation comprising particles that contain the following components i) to iii): i) anticholinergic agents, in particular at least one compound of formula 1, in which X? is a negatively charged anion, ii) at least one embedding material selected from the group consisting of mono- or disaccharides, oligosaccharides, polymers, sugar alcohols and cholesterol, and iii) an organic, physiologically acceptable, sterically demanding acid, selected from the group consisting of ascorbic acid, a monovalent, divalent or trivalent carboxylic acid, with the exception of amino carboxylic acids, to preferably fumaric acid, oxalic acid, or diacetic acid, and a fruit acid or culinary acid, preferably citric acid, tartaric acid, malic acid, lactic acid, acetic acid, ?-hydroxycaprylic acid or gluconic acid.

Abstract: The present invention relates to substituted N-(phenyl-heteroaryl)-3-acetylamino-benzamides and N-[3-(acetylamino)phenyl]-phenyl-heteroaryl-carboxamides of general formula (I) as described and defined herein, to methods of preparing said compounds, to intermediate compounds useful for preparing said compounds, to pharmaceutical compositions and combinations comprising said compounds and to the use of said compounds for manufacturing a pharmaceutical composition for the treatment or prophylaxis of a disease such as cancer, wherein i.a.: LA represents an optionally substituted methylene or ethylene group; LB represents —N(H)—C(?0)- or —C(?0)—N(H)—; R1 represents an optionally substituted 5- to 8-membered heterocycloalkyl, 4- to 10-membered heterocycloalkenyl, aryl, heteroaryl or —N(R7)(Ci-C6-alkyl) group; R2 represents an optionally substituted 5- or 6-membered heteroaryl group; R3 represents an optionally substituted phenyl group.

Abstract: The present invention is directed to a new pharmaceutical dosage form comprising mesoporous particles loaded with a poorly soluble active pharmaceutical ingredient, said particles being at least partially, preferably homogeneously, covered with a polymer solid dispersion.

Abstract: The present invention is directed to use of a series of tri-aryl compounds and compositions comprising the same for the treatment of diabetes and disease conditions arising as a consequence of the same.

Abstract: Amino, amido, and heterocyclic compounds are disclosed. The compounds may be prepared as pharmaceutical compositions, and may be used for the prevention and treatment of a variety of conditions in mammals including humans, including by way of non-limiting example, diabetes complications, inflammation, and neurodegeneration, obesity, cancer, ischemia/reperfusion injury, cardiovascular disease and other diseases related to RAGE activity.

Abstract: The invention comprises methods of modulating the complement cascade in a mammal and for treating and/or preventing diseases and disorders associated with the complement pathway by administering a compound of Formula I or Formula II, such as, for example, 2-(4-(2-hydroxyethoxy)-3,5-dimethylphenyl)-5,7-dimethoxyquinazolin-4(3H)-one or a pharmaceutically acceptable salt thereof.

Abstract: The present application provides 17 and/or 21 esters of 17?,21-Dihydroxypregna-4,9(11)-diene-3,20-dione and 17?,21 -dihydroxypregna-4-ene-3,20-dione having remarkable antiandrogenic activity, methods of using these compounds, and processes for their preparation.

Abstract: We disclose the use of 25-OH D3 (calcifediol) to increase muscle strength, muscle function, or both. Vitamin D3 (cholecalciferol) may optionally be used together with 25-OH D3. Forms and dosages of a pharmaceutical composition, as well as processes for manufacturing medicaments, are also disclosed.

Abstract: The disclosure provides controlled release compositions comprising tetracyclines and in some embodiments, doxycycline. The controlled release doxycycline compositions of the invention exhibit a superior dissolution profile and provide reduce side effects such as nausea and irritation.

Abstract: The present invention relates to a pharmaceutical composition for preventing or treating liver diseases, containing a plasmalogen precursor, plasmalogen, or a plasmalogen analog as an effective component. More specifically, a plasmalogen precursor, or plasmalogen or a plasmalogen analog produced by metabolizing the plasmalogen precursor, can prevent or treat liver diseases such as hepatic steatosis, hepatitis, or liver cirrhosis, etc. by decreasing accumulation of neutral fats in the liver, repressing expressions of inflammatory cytokine genes, and increasing fatty acid oxidation capacity of peroxisome.

Abstract: The present disclosure relates generally to alpha-helix mimetic structures and specifically to alpha-helix mimetic structures that are inhibitors of ?-catenin. The disclosure also relates to applications in the treatment of hepatic fibrosis, including hepatic fibrosis associated with hepatitis, hepatic fibrosis associated with hepatitis B infection, and non-alcoholic steatohepatitis (NASH), and pharmaceutical compositions comprising such alpha helix mimetic ?-catenin inhibitors.

Abstract: The invention pertains to the use of fused bicyclo heterocyclic adducts of thiohydroxy pyridines or pyrimidines as diacylglycerol O-acyltransferase 1 (DGAT-1) inhibitors to treat hyperlipidiemias and various diseases and disorders associated therewith. Other conditions also can be ameliorated or avoided, such as high postprandial triglycerides or diet-related hypertriglyceridemia, cardiovascular risk associated with excessive triglycerides, and insulin resistance/glucose intolerance in overweight patients, those with diabetes or other glucose metabolic disorders such as Syndrome X and/or polycystic ovary disease.

Abstract: Benzothiazole phosphonate analogs and methods of using the same to inhibit the activity of Amyloid Binding Alcohol Dehydrogenase and in the amelioration or treatment of Alzheimer's disease are provided.

Abstract: Oral dosage forms of bisphosphonate compounds, such as zoledronic acid, can be used to treat or alleviate pain or related conditions.

Abstract: Methods for treating and/or preventing periodontal disease with arginine silicate are disclosed. Methods may include the steps of identifying an individual in need of treatment for, or in need of prevention of, periodontal disease and administering an effective amount of an arginine-silicate complex to said individual. Arginine silicate may also be used to ameliorate one or more symptoms of periodontal disease. In some aspects, arginine silicate may be used to restore gum health and/or stop or reverse recession of the gums and/or the loss of gum tissue in the oral cavity.

Abstract: The present invention relates to a pH-responsive metal-catechol derivative nanoparticle for drug delivery based on a mussel adhesive protein, particularly Fe(III)-DOPA nanoparticle, and a method for preparing the same. A nanoparticle for drug delivery according to the present invention is prepared using a pH responsive substance, catechol derivative-metal complex, particularly Fe(III)-DOPA complex, based on a mussel adhesive protein. Thereby, the present invention has excellent biocompatibility, is capable of easily and quickly penetrating into a target cell, and releases a loaded drug under acidic conditions, which enables to selectively deliver a drug to a specific disease having an acidic environment.

Abstract: A construct for selectively delivering a compound of interest to a cell, includes (a) a bioresorbable polymer shell; (b) a nucleic acid duplex contained in said shell, the duplex comprising (i) an ATP binding nucleic acid, and (ii) a complementary nucleic acid hybridized to the ATP binding nucleic acid; (c) a compound of interest intercalated in or caged by the nucleic acid duplex; (d) optionally, but in some embodiments preferably, a cationic polymer in said polysaccharide shell; and (e) optionally, but in some embodiments preferably, a cell targeting ligand coupled to the polymer shell. The polymer shell is degraded in a cell of interest, or in the extracellular matrix of a tissue carrying said cell of interest, to release said duplex therein. The wherein said duplex is destabilized by binding of ATP in the cell of interest to release the compound of interest therein.

Abstract: A method of treating Hodgkin's disease in a subject. The method involves administering to the subject an effective amount of a water-soluble composition which includes a cocrystal composition containing doxorubicin and a theanine enantiomer.

Abstract: Compositions for treatment or prevention of synovitis are provided. The compositions contain a therapeutically effective amount of at least one of oleuropein, rutin or curcumin and preferably contain at least oleuropin. Methods for treatment or prevention of synovitis are also provided, and the methods include administering such compositions. The compositions can additionally include one or more of quercetin, hydroxytyrosol or vitamin D.

Abstract: The invention relates to modulation of SIRT3 activity levels. The invention has applications for regulating metabolism and mimicking caloric restriction or exercise in a muscle cell.

Abstract: The present invention relates to a method for arresting, protecting and/or preserving an organ which includes administering effective amounts of (i) a potassium channel opener or agonist and/or an adenosine receptor agonist and (ii) local anaesthetic to a subject in need thereof. The present invention also relates to a method for arresting, protecting and/or preserving an organ which comprises adding a composition which includes effective amounts of (i) a potassium channel opener or agonist and/or an adenosine receptor agonist and (ii) a local anaesthetic to the organ. The present invention further provides a pharmaceutical or veterinary composition which includes effective amounts of (i) a potassium channel opener or agonist and/or an adenosine receptor agonist and (ii) a local anaesthetic.

Abstract: Provided is an A3 adenosine receptor agonist (A3AR agonist) for the preparation of a pharmaceutical composition for the treatment of a mammal subject having osteoarthritis (OA), as well as to a method for the treatment of OA in a mammal subject, the method includes administering to said subject in need of said treatment an amount of A3AR agonist, the amount being effective to treat or prevent the development of OA. Preferred but not exclusive A3AR agonists in accordance with the present subject matter are IB-MECA and Cl-IB-MECA. The A3AR agonist may be administered in combination with another drug, such as Methotrexate (MTX). Also provided are pharmaceutical compositions for treatment of osteoarthritis including an amount of an A3AR agonist.

Abstract: It is disclosed a method for the treatment of hepatitis B (HBV) infection or HBV/hepatitis D (HDV) co-infection, the method comprising administering to a subject in need of treatment a first pharmaceutically acceptable agent that removes the hepatitis B surface antigen from the blood and a second pharmaceutically acceptable agent which stimulates immune function.

Abstract: The present invention relates to a prebiotic composition comprising a microbially produced oligosaccharide, wherein the oligosaccharide is characterised by being selective for a pre-determined probiotic bacterial strain and also capable of being produced by the pre-determined probiotic bacteria by reverse enzyme action. The present invention also relates to methods of screening a composition suitable for use as a prebiotic and methods for screening of prebiotics for incorporation into synbiotic formulations.

Abstract: The present invention relates to synergistic compositions which include mixtures of fermentable fibers. These compositions include inulin and arabinoxylan for use in reducing, preventing and/or treating inflammation. The arabinoxylan is partially hydrolyzed arabinoxylan and the ratio of inulin to arabinoxylan and/or partially hydrolyzed arabinoxylan is between 65%/35% by weight and 90%/10% by weight.

Abstract: The present invention discloses a pharmaceutical composition comprising a monosaccharide and/or polysaccharide as an active ingredient thereof, for decreasing the accumulation of di-carbonyl compounds in the human body. Said monosaccharide is a monomer of said polysaccharide, and the molecular weight of the polysaccharide ranges from 29 kDa to 36 kDa. The monosaccharide and/or polysaccharide can be used to prevent or treat nephritis or diseases associated with di-carbonyl compounds, or other diseases caused by carbonyl-stress, and can also be used to make the relevant drug.

Abstract: The present invention discloses a mercapto-modified biocompatible macromolecule derivative with a low degree of modification. The mercapto-modified biocompatible macromolecule derivative not only maintains the initial structure, physiological function and biocompatibility as much as possible, but also allows the preparation of the biocompatible macromolecule cross-linked material with a low degree of cross-linking through the effectively chemical cross-linking with the introduced mercapto group. The present invention further discloses a disulfide-bond cross-linked biocompatible macromolecule material with a very low degree of cross-linking.