Abstract: Embodiments include formulations and methods for oromucosal administration of a dry powder to create a topical foam composition to deliver medicaments to an interior mucosal space, such as the oral cavity, nasal cavity, rectal cavity, vaginal cavity or esophagus. The active agent can be amifostine, an antibiotic, an anti-fungal, a non-steroidal anti-inflammatory drug or a steroidal anti-inflammatory drug. Oromucosal delivery allows one to target oral epithelial cells. Embodiments also include methods of treating mucositis. Conventional formulations and methods are generally ineffective because drugs cannot be directed toward epithelial cells of the GI that are most susceptible to mucositis. The formulations described herein increase concentration, permeability and residence time at a target site. The formulations also allow stable forms of amifostine, which obviates difficulties associated with storing, dosing and administering the drug.

Abstract: Pharmaceutical formulations with a tropomyosin-related kinase inhibitor (“Trk inhibitor”) are disclosed. The pharmaceutical formulations comprise 3-(3-methoxy-4-((4-methoxybenzyl)oxy)benzyl)-6-(1-methyl-1H-pyrazol-4-yl)-3H-imidazo[4,5-b]pyridin-2-amine in microcrystalline suspension formulations in its monohydrate form, which shows improved characteristics over the anhydrate form, and in extended release formulations. The extended release pharmaceutical formulations comprise 3-(3-methoxy-4-((4-methoxybenzyl)oxy)benzyl)-6-(1-methyl-1H-pyrazol-4-yl)-3H-imidazo[4,5-b]pyridin-2-amine-loaded microspheres.

Abstract: A method of modulating plasma levels of branched chain amino acids and branched chain alpha-keto acids is disclosed, wherein an ammonia scavenger compound or a salt thereof, for example phenylbutyrate or an even numbered congener thereof or a salt thereof, is administered to an individual in need thereof. In various methods, a decrease in plasma levels of branched chain amino acids and branched chain alpha-keto acids is effected to treat individuals suffering from an inborn error in metabolism of amino acids, such as Maple Syrup Urine Disease, for example.

Abstract: The invention features compositions, methods, and kits containing (i) one or more cysteamine precursor compounds convertible to cysteamine in vivo, and (ii) optionally agents to enhance that conversion, formulated to produce a spectrum of pharmacokinetic profiles of cysteamine that can be tailored to individual patients and diseases. The invention also features varying modes of administration of the therapeutic substances in the treatment of cystinosis and other cysteamine sensitive disorders. In particular, formulations combining active ingredient(s) with pharmaceutical excipients that permit sustained cysteamine plasma concentrations are featured.

Abstract: The present methods treat neurofibromatosis by a administering to a subject perillyl alcohol or iso-perillyl alcohol. The present methods also treat neurofibromatosis by administering to a subject a carbamate of perillyl alcohol, or a carbamate of iso-perillyl alcohol. The perillyl alcohol carbamate may comprise perillyl alcohol conjugated with rolipram or temozolomide.

Abstract: The invention relates to a gel composition containing pirfenidone, which is advantageous over other cutaneously administered pharmaceutical forms known in the prior art and which can be used in treatment for the restoration of tissues with fibrotic lesions and for the prevention of fibrotic lesions.

Abstract: The present disclosure relates generally to peroxyformic acid forming compositions and methods for forming peroxyformic acid, preferably in situ, and peroxyformic acid formed by said compositions and methods for the purpose of treating an animal tissue and providing an antimicrobial function thereon. present disclosure in particular relates to a residue-free teat treatment composition for the treatment of an animal tissue, especially bovine teats, which provides antimicrobial efficacy and does not leave a non-food ingredient residue on treated teats.

Abstract: The present invention is directed to epinephrine spray formulations. The present invention is further directed to methods of treating anaphylaxis by administering epinephrine spray formulations to subjects in need of such treatments.

Abstract: Methods of treating anxiety disorders or reducing anxiety-related behaviors. The methods include administering a therapeutically effective amount of ketone supplementation, such as butanediol, ketone esters (e.g., 1,3-butanediol-acetoacetate diester) and/or ketone salts (e.g., beta-hydroxybutyrate-mineral salt), chronically, sub-chronically, or acutely, with or without admixture with a medium chain triglyceride or in combination. It was determined herein that ketone supplementation reduced anxiety in rats on elevated plus maze as measured by less entries to closed arms, more time spent in open arms, more distance travelled in open arms, and delayed latency to entrance to closed arms, when compared to control. Along with reducing anxiety-related behavior, the chronic, sub-chronic, and acute ketone supplements also caused significant elevation of blood ?HB levels and changed blood glucose levels.

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 com-positions 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: There is provided a new dosage regimen for Compound A which maximizes anti-tumor activity while maintaining acceptable toxicity levels.

Abstract: The present invention relates to dosing regimen of a new antimalarial drug, as monotherapy or combination therapy.

Abstract: This invention provides a high molecular weight polysaccharide capable of binding to and inhibiting virus and related pharmaceutical formulations and methods of inhibiting viral infectivity and/or pathogenicity, as well as immunogenic compositions. The invention further includes methods of inhibiting the growth of cancer cells and of ameliorating a symptom of aging. Additionally, the invention provides methods of detecting and/or quantifying and/or isolating viruses.

Abstract: Described herein are methods of treating non-metastatic castration-resistant prostate cancer in subjects with severe hepatic impairment with androgen receptor inhibitors, including but not limited to, 4-[7-(6-cyano-5-trifluoromethylpyridin-3-yl)-8-oxo-6-thioxo-5,7-diazaspiro[3.4]oct-5-yl]-2-fluoro-N-methylbenzamide.

Abstract: [[(2E)-2-[(3-methoxy-1,4-dioxo-1,4-dihydronaphthalen-2-yl)methylidene]-N,N-diethylpentanamide] (APX2009) and (2E)-2-[(3-methoxy-1,4-dioxo-1,4-dihydronapthalen-2-yl)methylidene]-N-methoxypentanamide] (APX2014) for inhibiting ocular diseases are disclosed herein.

Abstract: A method for contraception includes administering to a female daily, in a triphasic dosing regimen during a time period of 21 successive days, an oral combination drug formulation of levonorgestrel (LNG) and ethinyl estradiol (EE), wherein doses in the second, third and fourth phases of the regimen increase by a predefined dose increment as compared to the corresponding doses administered during the previous phase, wherein the LNG dose in the first phase is 100 mcg, in the second phase is 125 mcg, and in the third phase is 150 mcg, wherein the EE dose in the first phase is 20 mcg, in the second phase is 25 mcg, and in the third phase is 30 mcg, and wherein the triphasic dosing regimen is followed by 7 days without LNG and EE administration.

Abstract: The invention relates to the treatment or control of unipolar depressive disorder by administering a compound of Formula I or a salt thereof to a subject; wherein: E is S or Se; R1 and R2 are optional substituents, and are at each occurrence independently selected from: (1) a halogen, which is preferably selected from F, Cl and Br; (2) C1-C4 alkyl, such as C1-C2 alkyl or C1 alkyl, optionally substituted with one or more halogen atoms, each of which is preferably selected from F, Cl and Br; and (3) C1-C4 alkoxy, such as C1-C2 alkoxy or C1 alkoxy; optionally substituted with one or more halogen atoms, each of which is preferably selected from F, Cl and Br; m is an integer in the range of from 0 to 5; and n is an integer in the range of from 0 to 4.

Abstract: The present invention provides methods of maintaining stable remission or stable response achieved by a patient with depression following administration of a therapeutically effective amount of esketamine during an initial administration phase, comprising continuing administration of a therapeutically effective amount of esketamine for at least five months during a subsequent administration phase. The present invention also provides methods for the long term treatment of depression in a patient, comprising administering to the patient in need of the treatment a clinically proven safe and clinically proven effective therapeutically effective amount of esketamine for at least six months. In some embodiments, the depression is major depressive disorder or treatment resistant depression.

Abstract: Provided herein are compositions, methods and kits for effectively preventing, treating, reducing, mitigating, or controlling FSIAD.

Abstract: The present disclosure relates to a process for preparing a pharmaceutical formulation, said process comprises: i) blending chlorpromazine hydrochloride and microcrystalline cellulose under a first set of pre-determined conditions to obtain a first mixture; ii) blending lactose monohydrate with first mixture under a second set of pre-determined conditions to obtain a second mixture; iii) blending pre-gelatinized starch, colloidal silicon dioxide and magnesium stearate with second mixture under a third set of pre-determined conditions to obtain a third mixture; iv) screening the third mixture through #40 Mesh and dry blending under a fourth set of pre-determined conditions to obtain a fourth mixture; and v) directly compressing the fourth mixture to obtain the pharmaceutical formulation.