Abstract: The present invention relates to compounds and methods useful for selectively modulating mTORC1 activity.

Abstract: The present invention provides a modified release formulation of lacosamide. The modified release formulation of the present invention comprising lacosamide and modified release polymer provides modified release of lacosamide with minimal Cmax to Cmin peak to trough variation over a period of at least 12 hrs.

Abstract: The present invention encompasses an amino acid composition for stimulating muscle protein synthesis. Further, the present disclosure relates generally to the use of an anabolic amino acid composition for the stimulation of muscle protein synthesis. In particular, disclosed are compositions and methods of using the same for the prevention and/or treatment of a loss of any one of muscle mass, muscle strength, muscle function, and physical function, or any combination thereof, in a mammal, especially an adult mammal. Also provided are kits comprising a composition for the stimulation of muscle protein synthesis and, in certain embodiments, instructions for administration.

Abstract: An object of the present invention is to provide a novel composition for promoting ketone body production. The present invention provides a composition for use in promoting ketone body production, comprising one or more amino acid(s) selected from the group consisting of citrulline, leucine, cysteine, taurine, glutamine and aspartic acid. The composition according to the present invention may further comprise either or both of a medium-chain fatty acid and a medium-chain fatty acid ester.

Abstract: The present invention is related to a process for preparing safinamide and salts thereof, preferably safinamide methanesulfonate, with high yields and high enantiomeric and chemical purity without the need of using highly pure intermediates. The process of the present invention is suitable for the production of safinamide and its salts, preferably safinamide methanesulfonate, at industrial scale.

Abstract: The present invention relates to a method for decreasing the psychotomimetic side effects and enhancing the antidepressant-like effects of ketamine by the combination of ketamine with a methylglycine derivative. The present invention also relates to a method for depression treatment comprising administrating ketamine combined with a methylglycine derivative. The present invention further provides a method for preventing or treating addictive disorders of ketamine by administrating a methylglycine derivative.

Abstract: Disclosed are compound and methods of using the compounds for modulating ornithine aminotransferase (OAT) activity. The disclosed compound are characterized as analogs of 3-amino-4-(propan-2-ylidene)cyclopentane-1-carboxylic acid which may be formulated as therapeutic agents for treating diseases and disorders associated with ornithine aminotransferase (OAT) activity such as hepatocellular carcinoma and other cancers.

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: According to the subject invention, there is disclosed, a dosage and packaging configuration which includes the use of color-coded pre-filled syringes and vials to fill and refill infusion systems with existing and new dosage forms of intrathecal baclofen.

Abstract: A composition and methods of administration are provides utilizing Monosodium L-Glutamate Monohydrate in a stabilized form at an alkaline pH.

Abstract: The invention features a pharmaceutical suspension containing drug particles, a drug delivery device anchored in the mouth for continuously administering the pharmaceutical suspension, and methods of their use.

Abstract: Various side effects are reported for existing overactive bladder therapeutic drugs, and prophylactic or therapeutic agents for overactive bladder without side effects have been eagerly desired. The present invention provides a prophylactic or therapeutic agent for overactive bladder that comprises 5-aminolevulinic acids (ALAs) as the active ingredient.

Abstract: Long term storage stable bendamustine-containing compositions are disclosed. The compositions can include bendamustine or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable fluid which can include in some embodiments PEG, PG or mixtures thereof and an antioxidant or chloride ion source. The bendamustine-containing compositions have less than about 5% total impurities, on a normalized peak area response (“PAR”) basis as determined by high performance liquid chromatography (“HPLC”) at a wavelength of 223 nm, after at least about 15 months of storage at a temperature of from about 5° C. to about 25° C.

Abstract: Disclosed are enantiomerically pure cyclopentane-based compounds that are prepared by a multiple-step synthesis process. The disclosed compounds have been designed to inhibit gamma-aminobutyric acid-amino transferase (GABA-AT) activity and ornithine aminotransferase (OAT) activity. Some of the enantiomerically pure compounds inhibit OAT activity more potently than the racemic compound. The disclosed compounds may be used to selectively inhibit OAT activity, for example, to treat hepatocellular carcinoma and/or used to selected inhibit GABA-AT activity, for example, to treat neurological diseases and disorders.

Abstract: This disclosure provides methods of using compositions comprising amino acid entities to reduce fat infiltration in muscle, particularly under conditions of muscle atrophy. The disclosure also provides methods for enhancing muscle function by reducing fat infiltration in the muscle comprising administering an effective amount of the compositions to a subject in need thereof.

Abstract: Provided are a production method of a pregabalin-containing composition, which suppresses crystallization of pregabalin, and a pregabalin-containing composition that shows suppressed crystallization of Pregabalin. The production method of the pregabalin-containing composition of the present invention contains steps of: (1) dissolving pregabalin in an aqueous solution of an acid to prepare an aqueous solution of a salt of pregabalin; (2) mixing the aqueous solution of pregabalin salt and a hydrophilic resin to prepare a mixture thereof; and (3) concentrating the mixture; wherein the acid has an acid dissociation constant lower than that of pregabalin.

Abstract: The subject invention provides methods and procedures for synthesis and/or semi-synthesis of the novel antibiotic arsinothricin (AST) and derivatives. Arsinothricin (AST), a new broad-spectrum organoarsenical antibiotic, is a non-proteinogenic analog of glutamate that effectively inhibits glutamine synthetase. The subject invention provides chemical synthesis of an intermediate in the pathway of AST synthesis, hydroxyarsinothricin (AST-OH), which can be converted to AST by enzymatic methylation catalyzed by the ArsM As(III) S-adenosylmethionine methyltransferase. The methods provide a source of the novel antibiotic that will be required for future clinical trials. The subject invention also provides AST derivatives as a new class of antibiotics.

Abstract: The present disclosure is directed to acetyl-leucine or a pharmaceutically acceptable salt thereof for use in improving cognitive function, mobility, or cognitive function and mobility in a subject, for example, in an elderly subject.

Abstract: A method and composition for preserving muscle mass and function by increasing muscle protein synthesis and/or decreasing muscle protein degradation in mammals is disclosed. In one embodiment, the mammals are administered a protein building composition comprising at least two of an essential amino acid, an amino acid derivative, and a nitrogenous organic acid. In a particular embodiment, the protein building composition comprises leucine, L-carnitine, and creatine. The protein building composition can decrease TNF-? and increase mTOR expression in muscle.

Abstract: Formulations, methods of manufacturing, methods of stabilizing, kits, and uses as medicament are provided, for example for the treatment of pain. The formulations can comprise gabapentin optionally combined with at least one non-opioid pain drug in an aqueous carrier. The pharmaceutical formulation can have a pH of about 2.0 to about 10.0. The at least one non-opioid pain drug can be acetaminophen. The components can be included in any amount suitable for purposes of obtaining properties desirable for an injectable infusion, for example an intravenous infusion.

Abstract: The present invention provides method treating a subject suffering from a clinical condition associated with CXCR4 activity, said method comprising administering to a subject in need of such a treatment a therapeutically effective amount of a compound of the formula: or a pharmaceutically acceptable salt thereof, wherein a is 0 or 1; AA1 along with the sulfur atom that is attached thereto is 3-mercaptopropionic acid, optionally substituted cysteine, or optionally substituted homocysteine; AA2 along with the sulfur atom that is attached thereto is cysteine or homocysteine; Ar1 is an optionally substituted aryl; X1 is Arg, Dap, Dab, Orn, Lys, Dap(iPr), Dab(iPr), Orn(iPr), or Lys(iPr); X2 is Arg, Dap, Dab, Orn, Lys, Dap(iPr), Dab(iPr), Orn(iPr), Lys(iPr), a D-isomer thereof, or absent; X3 is Gly or absent; X4 is Phe, 2Nal, 1Nal, or absent; X5 is Gly or absent; R2 is —OR4 or —NHR5; R4 is H or alkyl; and R5 is H, alkyl, optionally substituted aryl, optionally substituted aralkyl.

Abstract: The invention features a pharmaceutical suspension containing drug particles, a drug delivery device anchored in the mouth for continuously administering the pharmaceutical suspension, and methods of their use.

Abstract: The present disclosure provides co-crystals of a substituted glycine compound and a co-former compound of Formula (I): compositions comprising such, and uses thereof in treating and/or reducing the risk for a neuropsychiatric disorder (e.g., schizophrenia, psychotic disorders, depressive disorders, suicidal ideation and/or behavior, obsessive compulsive disorder or Alzheimer's disease). Also provided herein are methods for preparing the co-crystals.

Abstract: A pulse photodynamic therapy (or pulse PDT) treatment of photodamaged skin is described.

Abstract: Methods of treatment using D-serine to target brain cells expressing GluN3 subunit-containing triheteromeric NMDARs are disclosed. The methods include inhibiting calcium ion uptake by brain cells, treating epilepsy, and treating seizures by artificially administering D-serine.

Abstract: Compositions and methods for the treatment of depression and psychoses in humans are disclosed. More particularly, the invention is directed to formulations containing antipsychotic and/or antidepressant medications and also containing an NMDAR antagonist. The present Invention Is also directed to methods tor the treatment of humans suffering from depression and other psychoses, including, schizophrenia, by administration of the inventive compositions in antidepressant and/or antipsychotic effective amounts.

Abstract: Disclosed are a fused tricyclic ?-amino acid derivative and a medical use thereof, in particular, the present invention relates to a fused cyclic ?-amino acid derivative as shown in general formula (I), or a stereoisomer, solvate, metabolite, prodrug, pharmaceutically acceptable salt or eutectic thereof, a pharmaceutical composition containing same, and the use of a compound or the composition in the field of analgesia, wherein the definitions of each substituent in general formula (I) are the same as the definitions in the description.

Abstract: The present invention provides pasty or liquid compositions for applications on mucous membranes of cavities easily reached by hand, having a bio-adhesive prolonged effect or release. The composition includes a polysaccharide matrix agent selected from the group constituting of lambda carrageenan and iota carrageenan. The matrix allows the in situ formation of a matrix film with a reinforced bio-adhesive capacity due to complexation reactions between the polysaccharide matrix agent and the components of the local secretions of the mucous membranes. The compositions can also include a lecithin compound as a reinforcing agent of the intrinsic bio-adhesive properties of the polysaccharide matrix agent. The composition can further include at least one of (a) a hydration medium for the polysaccharide matrix agent, (b) a lecithin co-solvent allowing the dispersion of the micellar lecithin solution in the hydration medium, (c) an additive or additives, and (d) at least one active ingredient.

Abstract: This disclosure provides methods of using compositions comprising amino acid entities to reduce fat infiltration in muscle, particularly under conditions of muscle atrophy. The disclosure also provides methods for enhancing muscle function by reducing fat infiltration in the muscle comprising administering an effective amount of the compositions to a subject in need thereof.

Abstract: The invention features a pharmaceutical suspension containing drug particles, a drug delivery device anchored in the mouth for continuously administering the pharmaceutical suspension, and methods of their use.

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: A medicament to be applied as an external preparation for therapeutic treatment of a local symptom of a neuropathic disease, which contains gabapentin or pregabalin in the form of an aqueous solution.

Abstract: Compositions and supplement formulations comprise at least one of Carnitine, Taurine, or derivative forms thereof. In one aspect, the composition or a supplement formulation comprises at least one Amino Acid constituent selected from the group consisting of Carnitine, Taurine, and derivative forms thereof; and at least one Nitrate constituent. In another aspect, the composition or a supplement formulation comprises a Nitrate of a compound selected from the group consisting of Carnitine, Taurine, and derivative forms thereof, wherein the Nitrate is a salt of Nitrate or a mixed salt of Nitrate. The compositions and supplement formulations may be formulated for improving athletic performance, increasing the bioabsorption of Carnitine, Taurine, or derivative forms thereof, or for increasing the vasodilative characteristics.

Abstract: The present invention relates to a foodstuff comprising feather hydrolysate for use in improving performance during exercise and/or improving recovery after exercise in a dog. It also relates to a method of improving the performance in a dog during exercise and/or improving recovery after exercise, the method comprising administering to a dog a foodstuff which comprises feather hydrolysate.

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

Abstract: The present invention provides a method for treating a human patient with a pathology by administering to the subject an effective amount of an agent selected from the group of: native full-length CCN3 proteins; analog CCN3 full-length proteins with native cysteine residues substituted by a replacement amino acid; CCNp native peptide fragments having from about 12 to about 20 amino acids; analog CCNp peptide fragments with native cysteine residues substituted with a replacement amino acid; and combinations thereof.

Abstract: The present disclosure provides co-crystals of a substituted glycine compound and a co-former compound of Formula (I): compositions comprising such, and uses thereof in treating and/or reducing the risk for a neuropsychiatric disorder (e.g., schizophrenia, psychotic disorders, depressive disorders, suicidal ideation and/or behavior, obsessive compulsive disorder or Alzheimer's disease). Also provided herein are methods for preparing the co-crystals.

Abstract: The invention features a pharmaceutical suspension containing drug particles, a drug delivery device anchored in the mouth for continuously administering the pharmaceutical suspension, and methods of their use.

Abstract: The present disclosure provides co-crystals of a substituted glycine compound and a co-former compound of Formula (I): compositions comprising such, and uses thereof in treating and/or reducing the risk for a neuropsychiatric disorder (e.g., schizophrenia, psychotic disorders, depressive disorders, suicidal ideation and/or behavior, obsessive compulsive disorder or Alzheimer's disease). Also provided herein are methods for preparing the co-crystals.

Abstract: D-serine is used to treat a neurological disorder, such as epilepsy, that cases seizures. A composition comprising D-serine is artificially administered to a patient in an effective amount by selectively contacting a region of the patient's brain with the composition. The region of the brain selectively contacted with the composition has cells expressing GluN3 subunit-containing triheteromeric NMDARs.

Abstract: The present invention is based on the finding that free amino acids can both negatively or positively influence overall taste of free amino acid-based enteral nutritional compositions, and the amino acids can thus be categorized. A striking balance of both categories of amino acids to arrive at amino acid-based nutritional composition with improved taste, yet not compromising the (regulatory) dietary restrictions on essential amino acids and conditionally essential amino acids.

Abstract: The invention features a pharmaceutical suspension containing drug particles, a drug delivery device anchored in the mouth for continuously administering the pharmaceutical suspension, and methods of their use.

Abstract: The present invention provides a pharmaceutical composition for oral administration comprising a D-amino acid combined with an antioxidant selected from the group consisting of vitamin E, vitamin C, a glutathione or a precursor thereof.

Abstract: The invention relates to a method and to a device for authenticating and/or identifying persons, objects, or service systems. In said method, a material, a construction, a substance, or a composition, or an image thereof, either changes itself or is actively changed, by means of a physical, chemical, or mechanical influence or feature, such that the resulting structure or feature is unforeseeable. If an image of said material, of the construction, of the substance, or the composition recorded at a later time is compared with the image stored in a storage means, the person and/or the object and/or the medium and/or service system is positively authenticated if the material, the construction, the substance, or the composition has at least partially changed between the two times in comparison with the image stored in the storage means.

Abstract: The present invention provides markers and methods for determining whether a subject, particularly a human subject, has or is at risk of developing, a disease such as cardiovascular disease, diabetes mellitus, insulin resistance, metabolic syndrome, NAFLD (Nonalcoholic Fatty Liver Disease) or NASH (Nonalcoholic Steatohepatitis) (e.g., within the ensuing year, two years, and/or three years). The present application also relates to the use of such markers and methods for monitoring the status of such diseases in a subject or the effects of therapeutic agents on subjects with such diseases.

Abstract: Methods of treating tinnitus with gaboxadol or a pharmaceutically acceptable salt thereof are provided. The methods provide therapeutic compositions that may be used to improve one or more symptoms of tinnitus.

Abstract: This invention relates to an ingestible drug delivery device configured for wireless communication with other ingestible drug delivery devices.

Abstract: A nutritional composition is provided which has an effective prophylactic and/or improving effect for various symptoms of muscle mass decrease, decreased basal metabolism, low body temperature, suppression of obesity, suppression of visceral fat accumulation, hyperglycemia, hyperlipidemia and the like in elderly people. The nutritional composition can include n-3 fatty acid and one or more of free lysine, dipeptides containing lysine, and lysine salts, wherein the content of free lysine, dipeptides containing lysine, and/or lysine salts is 0.1 g-10.0 g per 100 kcal of the composition, and the content of the total amount of n-3 fatty acid is 0.17 g-5.00 g per 100 kcal of the composition.

Abstract: A combination of dosage units for alleviating respiratory ailments and a method of alleviating respiratory ailments which uses this combination of dosage units. The dosage units comprise one or more first dosage units comprising pseudoephedrine and/or a pharmaceutically acceptable salt thereof and one or more second dosage units comprising phenylephrine and/or a pharmaceutically acceptable salt thereof.

Abstract: Biodegradable polyphosphazene polymers containing pyrrolidone side groups, and the biomedical use of such polyphosphazene polymers are disclosed.