Abstract: Methods for treating insomnia are disclosed. The methods are directed to administering a pharmaceutically effective amount of phosphodiesterase 5 (PDE5) inhibitor to a male individual suffering from insomnia. In addition, due to the PDE5 inhibitor positive effects on addressing erectile dysfunction (ED) in males, the present methods are directed to treating insomnia in patients that also suffer from ED by administering a pharmaceutically effective amount of a PDE5 inhibitor.

Abstract: The present invention in one embodiment provides a compound of Formula I: or a pharmaceutically acceptable salt thereof, wherein the variables shown in Formula I are as defined in the specification.

Abstract: Imipridones selectively modulate Class A G protein-coupled receptors (GPCRs), such as the D2-like subfamily of dopamine receptors, and are useful for treating conditions and disorders in need of such modulation, such as cancers. Specifically, the cancer is a midline glioma, a cancer having a histone H3 mutation, or both. In addition, methods of identifying whether a subject having these conditions, is likely to be responsive to a treatment regimen, such as imipridone administration, are provided. Furthermore, methods of assessing the effectiveness of a treatment regimen, such as imipridone administration, monitoring, or providing a prognosis for a subject with these condition are also provided.

Abstract: The disclosure also provides compositions and methods related to combination therapy with HSP90 inhibitors and BCL-2 pathway inhibitors for treating cancer. The disclosure also provides compositions and methods related to the use of low dose' HSP90 inhibitors in the treatment of cancer, alone and in combination with other therapeutic agents.

Abstract: The present invention is directed to methods of treating movement disorders by administering an effective amount of one or more adenosine A2A receptor antagonists to a patient in need thereof. The present invention also provides methods of decreasing the adverse effects of L-DOPA in patients receiving L-DOPA therapy in the treatment of Parkinson's disease. The present invention further provides methods and compositions for treating Parkinson's disease patients with sub-clinically effective doses of L-DOPA by combining L-DOPA treatment with an effective amount of one or more adenosine A2A receptor antagonists (i.e., L-DOPA sparing effect). The present invention further provides methods of effective treatment of Parkinson's disease by co-administering at least one adenosine A2A receptor antagonist, L-DOPA and a dopamine agonist and/or a COMT inhibitor and/or a MAO inhibitor.

Abstract: This invention is in the area of improved compounds, compositions and methods of transiently protecting healthy cells, and in particular hematopoietic stem and progenitor cells (HSPC) as well as renal cells, from damage associated with DNA damaging chemotherapeutic agents. In one aspect, improved protection of healthy cells is disclosed using disclosed compounds that act as highly selective and short, transiently-acting cyclin-dependent kinase 4/6 (CDK 4/6) inhibitors when administered to subjects undergoing DNA damaging chemotherapeutic regimens for the treatment of proliferative disorders.

Abstract: The present disclosure provides methods of treating and/or preventing inflammatory bowel disease (IBD) and graft-versus-host disease (GVHD) using salt-inducible kinase (SIK) inhibitors, such as macrocyclic SIK inhibitors of Formula (I), imidazolyl SIK inhibitors of Formula (II), and urea and carbamate SIK inhibitors of Formula (III-A) (e.g., urea and carbamate SIK inhibitors of Formula (III)).

Abstract: The use of 5H-dibenz/b,f/azepine-5-carboxamide derivatives for treating fibromyalgia. Useful 5H-dibenz/b,f/azepine-5-carboxamide derivatives include compounds of the formula (I): where R1 is hydrogen, alkyl, halogenalkyl, aralkyl, cycloalkyl, cycloalkylalkyl, alkoxy, aryl, or pyridyl; the term alkyl means a straight or branched hydrocarbon chain containing from 1 to 18 carbon atoms; the term halogen means fluorine, chlorine, bromine or iodine; the term cycloalkyl means an alicyclic saturated group with 3 to 6 carbon atoms; and the term aryl means an unsubstituted phenyl group or phenyl substituted by alkoxy, halogen or nitro group.

Abstract: Methods for treating tumors comprise contacting tumor cells expressing the vitamin D receptor with a vitamin D receptor ligand that inhibits homologous recombination in the tumor cells, and contacting the tumor cells with an amount of a Poly(ADP) Ribose Polymerase 1 (PARP-1) inhibitor. Inhibiting homologous recombination produces a synergistic therapeutic effect between the vitamin D receptor ligand and PARP-1 inhibitor, and may overcome PARP-1 resistance in killing tumor cells.

Abstract: The present invention relates to the discovery that MK2 is highly expressed in cancer tissue and the inhibition of MK2 using an MK2 inhibitor represents a viable approach to the treatment of cancer, including drug resistant cancers, metastatic cancers and recurrent cancers. MK2 inhibitors as described herein may be used alone or in combination with an at least one additional anti-cancer agent for the treatment of cancer.

Abstract: There is provided a transnasal anticonvulsive pharmaceutical composition including a poorly soluble anticonvulsant. The anticonvulsive pharmaceutical composition comprising a poorly soluble anticonvulsant as an active component, which is transnasally spray-administered, comprises diethylene glycol monoethyl ether and fatty acid ester, wherein the fatty acid ester is selected from the group consisting of caprylocaproyl polyoxylglyceride, isopropyl palmitate, oleoyl polyoxylglyceride, sorbitan monolaurate 20, methyl laurate, ethyl laurate and polysorbate 20. Also, the anticonvulsive pharmaceutical composition comprising a poorly soluble anticonvulsant as an active component, which is transnasally spray-administered, comprises diethylene glycol monoethyl ether, fatty acid ester, methylpyrrolidone, water and alcohol. Therefore, the transnasal anticonvulsive pharmaceutical composition may be useful to highly enhance the bioavailability of the poorly soluble anticonvulsant.

Abstract: The present invention relates to a unit dosage composition in the form of a film or a water containing from 0.25 mg to 2 mg of midazolam or a pharmaceutically acceptable salt thereof, and a film-forming substance.

Abstract: The present disclosure relates to compositions and combinations comprising one or more insulin(s) and one or more vasoactive agent(s), and use thereof for increasing subcutaneous insulin absorption and/or treating diabetes and/or treating or preventing hyperglycemia or complications in a patient in need thereof.

Abstract: A new and novel method for determining post procedural treatment is disclosed herein. In one embodiment, the method includes the steps of: determining a depth at which a surgical procedure on at least one eye of a patient is to be performed or was performed; providing a first set of instructions for administering a first medication for a first length of time to said at least one eye of said patient, said first length of time based at least in part upon said depth; providing a second set of instructions for administering a second different pressure lowering medication for a second length of time to said at least one eye of said patient, and physically administering the first medication and second different pressure lowering medication based upon the instructions.

Abstract: Provided oral testosterone undecanoate compositions can be administered to hypogonadal males with a meal without the fat content of the meal substantially effecting bioavailability.

Abstract: Disclosed herein are emulsions comprising testosterone or related androgens, castor oil, cyclodextrin, Pemulen TR-2, Polyoxyl 40, and other ingredients. The compositions are useful for treating keratoconjunctivitis sicca and meibomian gland disease.

Abstract: Pharmaceutical compositions for co-administering estradiol and progesterone to a human subject in need thereof are provided. In some embodiments, the pharmaceutical composition comprises solubilized estradiol, suspended progesterone, and a solubilizing agent comprising a medium chain (C6-C12) oil.

Abstract: Provided are steroid analogues functionalized with polar substituents at the C3 and/or C20 positions of the steroid ring system that exhibit improved water solubility. Also provided are pharmaceutical compositions comprising the steroid analogues and methods using the novel steroid analogues for the treatment and prevention of neurodegeneration in a patient following injury to the central nervous system.

Abstract: Bile acids and related compositions and methods of synthesis and use. More specifically, deoxycholic acid and related compositions, said compositions being free of all moieties of animal origin and free of pyrogenic moieties.

Abstract: The subject-matter of the present invention is the use of a therapeutic composition comprising, in an applying carrier, at least one essential oil for relieving muscle and/or joint pain in an animal subject, wherein said composition topically treats an area of the skin of said subject, characterized in that said composition comprises methyl salicylate, which constitutes, with at least one essential oil of the composition containing same in only a small amount or not at all, an active agent within which the rate of transport of the methyl salicylate through the skin is increased by virtue of the oil, which is an essential oil.

Abstract: A method of treating cancer in a subject is disclosed. The method comprises administering to the subject: (i) a therapeutically effective amount of an inhibitory agent that down-regulates an amount of a polypeptide selected from the group consisting of BCL-2, MCL-1 and cyclin D1; and (ii) a therapeutically effective amount of a CXCR4 binding agent that increases the expression of miR-15a and/or 16-1, thereby treating the cancer.

Abstract: The invention relates to novel veterinary compositions comprising torasemide or a pharmaceutically acceptable salt thereof and administered in domestic animals according to a predetermined dosage for symptomatic treatment of pulmonary edema associated with heart failure.

Abstract: The disclosure provides methods of treating cancer in a subject or preventing a relapse or reducing the incidence of relapse of cancer in a subject in remission, comprising administering to the subject: (a) a therapeutically effective amount of an immunotherapeutic agent, e.g., an immune checkpoint blockade therapy, an adoptive cellular therapy, a marrow-infiltrating lymphocytes, an adenosine A2aR inhibitor, or an antibody; and (b) a compound having formula (I): and the pharmaceutically acceptable salts thereof, wherein R1, R2, R2?, and X are as defined as set forth in the specification. Compounds having formula (I) are prodrugs that release glutamine analogs, e.g., 6-diazo-5-oxo-L-norleucine (DON).

Abstract: This disclosure pertains to new compositions and methods comprising a psilocybin derivative. In one embodiment, the compositions disclosed herein are used for a method of regulating a neurotransmitter receptor, e.g., a serotonin receptor. In one embodiment, the compositions disclosed herein comprise purified compounds, e.g., a purified psilocybin derivative, a purified cannabinoid, or purified terpene.

Abstract: The present disclosure describes various formulations and compositions for improving one's vitality and health. The formulations may be particularly useful for treating or alleviating at least erectile dysfunction, increasing muscle mass, and encouraging saliva and tear production. In one example such a composition may include 1-methylfolate, methylcobalamin, n-acetylcysteine, pterostilbene, and nicotinamide riboside.

Abstract: Borocarbohydrate complex containing compositions are presented that have an improved di-complex to boric acid ratio. In some embodiments, compositions are characterized by a di-complex to boric acid ratio of at least 5:1 and more typically at least 10:1 in liquid form, and at least 20:1 in dried form. In other embodiments, compositions are characterized by a minimum content of 80 wt % di-complex and a boric acid content of less than 15 wt %, and more typically less than 5 wt %. Contemplated compositions are thought to have improved biological activity and reduced content of undesired components.

Abstract: Disclosed is a TLR4 agonist alone or in combination with an anti-cancer agent and pharmaceutical compositions thereof, uses thereof, and methods of treatment comprising administering said composition or combination, including uses in cancer.

Abstract: Compositions and methods for detection and assessment of galectins are provided by the present invention, including a labeled compositions, pharmaceutical composition including a labeled composition for galectin detection and a pharmaceutically acceptable carrier, method of aiding in diagnosis and/or treatment of a condition characterized by upregulation of one or more galectins in a subject in need thereof and precursor compositions for synthesis of chemical compositions, including but not limited to labeled compositions for detection and assessment of galectins.

Abstract: The present invention relates to a composition comprising a phosphorothioate oligonucleotide and at least one fatty acid and/or at least one emulsifying agent, wherein said composition is sterile and wherein said composition comprises at least one agent comprising a thiol group and at least one phosphate compound, preferably said composition is an ophthalmic composition. The present invention also relates to a method for obtaining the same and to the therapeutic use thereof.

Abstract: Disclosed are methods for delivering a therapeutic or diagnostic agent to the cytosol of a cell in a subject. The disclosed methods generally include administering to the subject an effective amount of a lipid nanoparticle comprising the therapeutic or diagnostic agent and an effective amount of a membrane-destabilizing polymer. Also disclosed are related compositions and delivery systems.

Abstract: The present embodiments relate to the use of dextran sulfate formulated for systemic administration for treatment, inhibition or prevention of cardiac fibrosis in a subject.

Abstract: Disclosed are ophthalmic formulations which use complexes called L/H-HA, obtainable by subjecting at least two fractions of hyaluronic acids and/or other glycosaminoglycans with different molecular weights to an appropriate heat cycle.

Abstract: The present invention relates to compositions comprising a silicate and methods of use thereof. In particular, the compositions of the present invention are suitable for treating inflammatory conditions, cancer, bacterial and viral infections, and infected and uninfected wounds. The compositions of the present invention can also be useful in treating spinal cord injury, tissue remodeling, and promoting bone growth and repair.

Abstract: In some embodiments, the invention includes therapeutic combinations of antiviral active pharmaceutical ingredients and anti-inflammatory active pharmaceutical ingredients, including steroids, and methods of using of the therapeutic compositions in the treatment of viral infections.

Abstract: Disclosed herein are topical ophthalmic compositions comprising ammonium chloride, a quaternary ammonium salt, and stabilized chlorine dioxide. Also disclosed herein are methods of treating or preventing active infections of the tissues comprising the eye and surrounding parenchyma from bacterial, fungal, mycobacterial, mycoplasmal, viral, and protozoan amoeba microorganisms.

Abstract: Risk of visual impairment including Age-Related Macular Degeneration (AMD) and cataracts increase with age. This increased risk can be caused by changes in the structure and function of the eye or changes in structures of the central nervous system that support visual perception. The present invention comprises fruit flavored, chewable formulations of supplements for reducing the risk of AMD. Chewable dosage forms of the invention are preferred over other formulations and may increase compliance in an aging population, who are more likely to require an eye health supplement and have an increased risk of experiencing dysphagia.

Abstract: Methods and compositions are provided for combined transplantation of a solid organ and hematopoietic cells to a recipient, where tolerance to the graft is established through development of a persistent mixed chimerism. An individual with persistent mixed chimerism, usually for a period of at least six months, is able to withdraw from the use of immunosuppressive drugs after a period of time sufficient to establish tolerance.

Abstract: Methods and compositions are provided for combined transplantation of a solid organ and hematopoietic cells to a recipient, where tolerance to the graft is established through development of a persistent mixed chimerism. An individual with persistent mixed chimerism, usually for a period of at least six months, is able to withdraw from the use of immunosuppressive drugs after a period of time sufficient to establish tolerance.

Abstract: The present invention relates to methods for the improved treatment of an inflammatory disorder, where the treatment comprises administration of sex-matched stem or progenitor cells, such as mesenchymal stem cells (MSCs), or sex-matched cell secretions, or a combination thereof to a subject. The invention also relates to kits and compositions which may be used in such methods.

Abstract: The invention provides compositions comprising mesenchymal stem cell (MSC) derived exosomes, and methods of their use in subjects having certain lung diseases including inflammatory lung disease.

Abstract: A pharmaceutical preparation and method for treating connective tissue damage in a mammal comprising administering to a mammal in need thereof a therapeutically effective amount of a glycosaminoglycan composition comprising chondroitin sulfate, hyaluronan, and N-acetyl D-glucosamine, wherein the connective tissue is skin.

Abstract: Isolated extracellular matrix from marrow adherent stromal cells and their descendents, which stimulates the growth and survival of a number of different neural cell types, is provided, along with methods for preparation and uses.

Abstract: The present invention provides a composition based on poly-l-lactic acid (PLLA) acid polylactic-co-glycolic-acid (PLGA) scaffold on which neuronal tissue can ex-vivo grow. Further, more the invention provides a method for making cellular vasculature networks and a method for treating a neuronal injury in a subject, by implanting the current composition.

Abstract: A Muscular Dystrophy Chimeric Cell generated by ex vivo fusion of a myoblast with a second myoblast, mesenchymal stem cell, or stromal cell is described as is the use of the same in the treatment of a muscular dystrophy.

Abstract: Disclosed are means, methods and compositions of matter for treatment of dry eye disease using factors released from placental amniotic tissue when cultured in a liquid media. In one embodiment of the invention amnion is extracted from a hemochorial placenta and cultured in a means to maintain viability of said amnion. Said means in which hemochorial placenta amnion is maintained viable is subsequently used to collect factors which are released by said placental amnion which are useful for treatment of dry eye disease either in unpurified form, in concentrated form, or specific molecular weight fractions derived thereof.

Abstract: Described herein are compositions composed of micronized placental components, extracts of micronized placental components, and pharmaceutical compositions thereof. The compositions have numerous medical applications. Methods for making and using the micronized compositions and the extracts thereof are also described herein.

Abstract: Methods are described for differentiating stem and post-natal cells into sex hormone-producing cells that can be administered to a patient autologously or allogeneically in order to maintain in balance, or rebalance, their hypothalamic-pituitary-gonadal (HPG) axis.

Abstract: This invention relates to the combination of manuka honey with other chemotherapeutic agents to treat cancer and reduce the toxicity of the treatment. The invention relates also to an intravenous pharmaceutical composition comprising a diluent; at least 50% w/v of manuka honey diluted by the diluent; and at least one chemotherapeutic agent selected from the group consisting of paclitaxel 5 mg/kg of a patient to be treated; paclitaxel 8 mg/kg of a patient to be treated; oxaliplatin 6 mg/kg of a patient to be treated; and any pharmaceutically acceptable salts thereof. The invention relates further to a method of treating skin cancer, colon cancer, colorectal cancer and/or breast cancer in a patient comprising administering the intravenous pharmaceutical composition to the patient.

Abstract: The invention provides compositions comprising one or more bacterial strains for treating or preventing visceral hypersensitivity.

Abstract: A dry stable probiotic composition is provided. The composition comprises one or more viable probiotic microorganisms, one or more hydrolyzed proteins, one or more disaccharides, one or more oligosaccharides, and one or more polysaccharides, but not trehalose. The composition has viability of at least 1×1010 CFU/g, and a viability loss of less than 1 log unit/g after 3 months at a temperature of 40° C. and a relative humidity of 33%. Also provided are methods for preparing the dry stable probiotic composition.