Abstract: The present invention relates to new formulations containing one or more estrogens and 2-Phenyl-1-[4-(2-Aminoethoxy)-Benzyl]-Indole compounds which are useful as estrogenic agents, as well as pharmaceutical compositions and methods of treatment utilizing these compounds, which have the general structures below:

Abstract: Hormone replacement therapies are provided comprising solubilized progesterone alone and optionally with an estrogen, cyclic/sequential and continuous-combined dosing, and administered via transdermal HRT delivery systems.

Abstract: Embodiments of the invention are directed to methods of determining the prognosis of a breast cancer patient by evaluating the activity of the glucocorticoid receptor in tumor cells. Other embodiment include methods of treating breast cancer cells, particularly, chemo-resistant cells, with a glucocorticoid receptor antagonist and an anticancer agent or compound.

Abstract: A drug delivery system consisting of one or more compartments and comprising a progestogenic compound dissolved in a thermoplastic polyethylene vinylacetate copolymer whereby, if the delivery system consists of one compartment, the compartment comprises (i) a core of a thermoplastic polyethylene vinylacetate copolymer comprising the progestogenic compound, such progestogenic compound being dissolved in the polyethylene vinylacetate copolymer up to a concentration below the saturation level at 25° C., and an estrogenic compound; and (ii) a skin of a thermoplastic polyethylene vinylacetate copolymer covering the core, said skin being permeable for both compounds; if the delivery system consists of more than one compartment, only one compartment comprises (iii) the progestogenic compound, such progestogenic compound being dissolved in a core of a thermoplastic polyethylene vinylacetate copolymer up to a concentration below the saturation level at 25° C.

Abstract: A stanol composition containing in addition to sitostanol as the main component, also a substantial amount of at least 10% campestanol has been found to effectively lower serum cholesterol levels when incorporated in edible commodities. Upon esterification the composition is especially useful in edible fats and oils and in fat-containing foods.

Abstract: The invention relates to a pharmaceutical composition of unit dose for inhalation by a human subject comprising a topical corticoid and a quinolone or fucidic acid, characterized in that the ratio of the weight of the topical corticoid to the weight of the quinolone or fucidic acid is between 0.02 and 20 and the amount of quinolone or of fucidic acid is less than 1 mg. This composition can be administered by nasal spray and is used for treating the upper and lower respiratory tract, in particular sinusitis and nasal polyps.

Abstract: A method of contraception in a female is provided. The method includes administering to the female daily for a first number of successive days an oral combination drug formulation of a progestin and an estrogen. The oral combination drug formulation is administered in a multiphasic dosing regimen comprising a second number of phases with duration of each phase is a third number of days. The doses of each of the progestin and estrogen in each subsequent phase of the regimen increase by a predefined dose increment as compared to the corresponding doses of the progestin and estrogen administered during immediately preceding phase of the regimen. The ratio of a daily dose of progestin to a daily dose of estrogen is maintained at a constant level during the entire dosing period. The first number of successive days period is followed by a fourth number of days without progestin and estrogen administration.

Abstract: The subject invention pertains to the treatment of tumors and cancerous tissues and the prevention of tumorigenesis and malignant transformation through the modulation of JAK/STAT3 intracellular signaling. The subject invention concerns pharmaceutical compositions containing cucurbitacin I, or a pharmaceutically acceptable salt or analog thereof. Another aspect of the invention concerns methods of inhibiting the growth of a tumor by administering a cucurbitacin I, or a pharmaceutically acceptable salt or analog thereof, to a patient, wherein the tumor is characterized by the constitutive activation of the JAK/STAT3 intracellular signaling pathway. The present invention further pertains to methods of moderating the JAK and/or STAT3 signaling pathways in vitro or in vivo using cucurbitacin I, or a pharmaceutically acceptable salt or analog thereof. Another aspect of the present invention concerns a method for screening candidate compounds for JAK and/or STAT3 inhibition and anti-tumor activity.

Abstract: Methods of reducing or abolishing neuropathic pain in humans and animals are discussed. In some examples administration of the apoptosis inhibitor taurours-odeoxycholic acid (TUDCA), greatly reduced both neuronal loss and the increase in glia, and partially reversed spinal nerve ligation (SNL)-induced mechanical hypersensitivity. Among RVM neurons, serotonergic (5-HT) neurons decreased by 35% ipsilateral to SNL. In some examples, the density of 5-HT immunoreactive varicosities in the superficial dorsal horn of the spinal cord was lower ipsilateral to SNL. The RVM 5-HT neurons that remained after SNL appeared to facilitate nociception. When rats that had undergone SNL were treated with the 5-HT neurotoxin, 5,7-dihydroxytryptamine (5,7-DHT), mechanical withdrawal thresholds increased significantly. In some examples nerve injury induces death of antinociceptive RVM neurons which can be reduced or abolished by TUDCA.

Abstract: The present invention utilizes phytosterol, phytoecdysteroid, sapogenin, triterpene, terpene, spirostane, spirostene and androstene derivative compounds to provide a wide variety of utilities to humans and other animals. The compounds and methods provide numerous and wide-ranging benefits including biochemical and constructive metabolic benefits including increases in protein synthesis and synthesis efficiency, ergogenic, adaptogenic, cosmetic and medicinal skin agents and veterinary utilities. The compounds provide agents that increase physical endurance and work output, act as a general tonic for increasing health and vigor, increase sleep time and sleep efficiency and act as rejuvenating agents to reverse the effects of fatigue and stress. Novel utilities for pet, farm, zoo and companion animals are also provided.

Abstract: Polymorphic forms of onapristone and methods of making and using such polymorphic forms are provided. Crystalline polymorphic forms can be characterized by their X-ray powder diffraction patterns and other properties.

Abstract: A method for the treatment of eyelid dermatitis and/or dermatitis of the periorbital area is provided.

Abstract: A drug and device combination system used in a method for treatment of patients suffering from severe and oral corticosteroid-dependent asthma and other respiratory diseases requiring a treatment with orally administered steroids. The method for administration of the inhalable corticosteroid by a flow rate and volume regulated inhalation. The combination system of the inhalable corticosteroid and the device for regulating flow rate and volume of the inhalable corticosteroid and thus achieving delivery of said inhalable corticosteroid into the small airways of the lungs. The individually programmable device that assures safe and reproducible corticosteroid delivery compliant with treatment protocol.

Abstract: A transdermal drug delivery device for reducing the risk of pregnancy in overweight women is disclosed. Methods of using the device are also disclosed. When used in accordance with the disclosed methods, the probability that the device will be effective in overweight women is approximately equal to or greater than the probability that the device would be effective in the case of a woman who is not overweight.

Abstract: A drug delivery system for oral administration of hydrophobic drugs with enhanced and extended absorption and improved pharmacokinetics is provided. In one embodiment, formulations comprising testosterone and testosterone esters, e.g., testosterone palmitate, are disclosed. Methods of treating a hormone deficiency or effecting male contraception with the inventive formulations are also provided.

Abstract: The present invention relates to a medicament, the active ingredient combination of which consists of a retinoid selected from the group consisting of acitretin [9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethylnona-2,4,6,8-tetraenoic acid], etretinate [ethyl 9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethylnona-2,4,6,8-tetraenoate], isotretinoin [3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid] and tretinoin [3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexenyl)nona-2,4,6,8-tetraenoic acid] and of a hormone combination with contraceptive action of an oestrogen component and a gestagen component, and to a dosage form consisting of at least 28 daily units, of which the final 7-3 daily units contain only the retinoid as active ingredient and the other daily units also contain the hormone-containing active ingredient combination, and to the use thereof for treating acne, seborrhoea or psoriasis.

Abstract: Methods and compositions for treating cancer are described herein. More particularly, the methods for treating cancer comprise administering a 17?-hydroxylase/C17,20-lyase inhibitor, such as abiraterone acetate (i.e., 3?-acetoxy-17-(3-pyridyl)androsta-5,16-diene), in combination with at least one additional therapeutic agent such as an anti-cancer agent or a steroid. Furthermore, disclosed are compositions comprising a 17?-hydroxylase/C17,20-lyase inhibitor, and at least one additional therapeutic agent, such as an anti-cancer agent or a steroid.

Abstract: Provided is a fat or oil composition, comprising the following components (A) and (B): (A) 0.4 to 6 mass of a free type triterpene alcohol; and (B) 0.2 to 3 mass of a free type phytosterol containing 20 mass % or more of 3-sitosterol, in which a content mass ratio of the free type triterpene alcohol (A) to the free type phytosterol (B), [(A)/(B)], is 0.9 or more.

Abstract: Compositions, preferably pharmaceutical compositions, containing micronized tanaproget, or pharmaceutically acceptable salt thereof, microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, butylated hydroxyanisole, povidone, and magnesium stearate, are provided. The compositions are useful in contraception and hormone replacement therapy and in the treatment and/or prevention of uterine myometrial fibroids, benign prostatic hypertrophy, benign and malignant neoplastic to disease, dysfunctional bleeding, uterine leiomyomata, endometriosis, polycystic ovary syndrome, and carcinomas and adenocarcinomas of the pituitary, endometrium, kidney, ovary, breast, colon, and prostate and other hormone-dependent tumors, and in the preparation of medicaments useful therefor. Additional uses include stimulation of food intake.

Abstract: An injectable preparation of estrogenic and progestrogenic hormonal compounds in an anhydrous excipient injected to synchronize estrus in non-menstruating placental female animals, and a five to nine day protocol to apply the unique preparation to achieve estrus synchronization.

Abstract: The present invention provides compositions, desirably pharmaceutical compositions, containing micronized tanaproget. The compositions can also contain microcrystalline cellulose, croscarmellose sodium, anhydrous lactose, magnesium stearate, micronized edetate calcium disodium hydrous, and micronized sodium thiosulfate pentahydrate. The compositions are useful in contraception and hormone replacement therapy and in the treatment and/or prevention of uterine myometrial fibroids, benign prostatic hypertrophy, benign and malignant neoplastic disease, dysfunctional bleeding, uterine leiomyomata, endometriosis, polycystic ovary syndrome, and carcinomas and adenocarcinomas of the pituitary, endometrium, kidney, ovary, breast, colon, and prostate and other hormone-dependent tumors, and in the preparation of medicaments useful therefor. Additional uses include stimulation of food intake.

Abstract: The invention provides methods for treatment of conditions which require phytosterol therapy without adversely affecting the bioavailability of lipophilic vitamins or lipophilic drugs. The method includes administering a mixture of phytosterol ester(s) (PS-E) and 1,3-diglyceride(s) (DAG) dissolved in an edible oil or fat. The invention also provides a method of improving weight management and a method of treating metabolic conditions that result in overweight. Dietary nutrients, food supplements and food articles containing the mixture are also provided.

Abstract: Described are transdermal drug delivery systems for the transdermal administration of levonorgestrel and ethinyl estradiol, comprising an acrylic polymer matrix. Methods of making and using such systems also are described.

Abstract: In various embodiments, the present invention provides compositions comprising eicosapentaenoic acid or a derivative thereof and obeticholic acid or a derivative thereof. In other embodiments, the present invention provides methods of treating and/or preventing NASH and/or PBC comprising co-administering to a subject in need thereof eicosapentaenoic acid or a derivative thereof and obeticholic acid or a derivative thereof.

Abstract: The invention provides transdermal delivery systems, medical kits, and methods for using the transdermal delivery systems and kits for medical applications, such as delivery of contraceptive agents to control fertility.

Abstract: A hormone delivery system and method are provided for administering bioidentical human hormones using a combination of modalities for the treatment of human physiological conditions.

Abstract: A combination hormone and melatonin therapy is provided to reduce the risk of developing, or to reduce the severity of, breast cancer by administering at least one estrogen hormone and optionally at least one progesterone-receptor-binding compound or composition and melatonin together, preferably at normal bed time.

Abstract: The present invention relates to the composition and method of use for the topical application of the potent androgen hormone dihydrotestosterone (DHT), used alone or in fixed combination with other hair growth medications; including other androgens, bimatoprost, other prostamides, prostaglandins, minoxidil or apocrine hair growth factors to promote and enhance hair growth of terminal mustache hair, beard hair, also chest hair, and other male androgen sensitive or dependent hair growth in humans or animals.

Abstract: This invention pertains to the discovery that agents which inhibit the binding of cortisol to its receptors can be used in methods for preventing neurological damage associated with glucocorticoid therapy in ventilator-dependent low birth weight preterm infants. Mifepristone, a potent glucocorticoid receptor antagonist, can be used in these methods.

Abstract: The subject invention provides a drug delivery system comprising at least one compartment comprising (i) a drug-loaded thermoplastic polymer core layer, (ii) a drug-loaded thermoplastic polymer intermediate layer and (iii) a non-medicated thermoplastic polymer skin covering the intermediate layer, wherein said core layer is loaded with crystals of a first (pharmaceutically) active compound and said intermediate layer is loaded with, crystals of the second (pharmaceutically) active compound.

Abstract: Some embodiments of the present invention provide pharmaceutical formulations, for treating atherosclerosis in a mammal, including a bile acid and/or a terpene atherosclerotic plaque emulsifier. Some embodiments provide methods for administering such pharmaceutical formulations. In some embodiments, pharmaceutical formulations include a combination of a bile acid and a terpene in amounts effective to result in plaque regression, and the amount of each individual emulsifier in the combination can be lower than an amount that is effective to result in plaque regression when the emulsifier is administered alone. In some embodiments, a statin can be administered simultaneously or sequentially with the pharmaceutical formulation.

Abstract: The present invention relates to pregnancy hormone combinations and methods of treatment for autoimmune diseases having at least two hormonal components, a pregnancy hormone (such as estriol), and a gestagen (such as levonorgestrel or norethindrone) thereby providing for the continuous, uninterrupted administration of pregnancy hormones for the treatment for autoimmune disorders, such as multiple sclerosis.

Abstract: The present invention relates to the diuretic effects of nitrate esters of corticoid compounds. A patient in heart failure may be treated by administering a therapeutically effective dosage of a pharmaceutical composition comprising a nitrate ester of corticoid compound as a diuretic having the general formula B—X1—NO2. A method of improving kidney function by administering a therapeutically effective dosage of a pharmaceutical composition having a nitrate ester of corticoid compound of the same formula is also described.

Abstract: The present invention relates to triazolopyridine compounds of general formula (I): in which R1, R2, R3, R4, and R5 are as given in the description and in the claims, to methods of preparing said compounds, to pharmaceutical compositions and combinations comprising said compounds, to the use of said compounds for manufacturing a pharmaceutical composition for the treatment or prophylaxis of a disease, as well as to intermediate compounds useful in the preparation of said compounds.

Abstract: Novel testosterone formulations are disclosed where testosterone is incorporated into a phospholipid/cholesterol system to produce a proliposomal powder dispersion. The proliposomal powder dispersions of the invention may be formulated with pharmaceutically acceptable excipients to form pharmaceutical compositions. Enterically coated oral dosage forms are disclosed as are methods of treatment for testosterone replacement therapy.

Abstract: The present invention relates to a patch comprising a drug-containing layer with low content of hormones, such as gestodene, and optionally an estrogen (e.g. ethinyl estradiol). Upon administering the patch to a woman, plasma levels of at least 1.0 ng/ml of Gestodene is achieved at steady state conditions without the need of incorporating penetration enhancers or permeation enhancers in the drug-containing layer. Satisfactorily plasma levels of the hormones is also achieved throughout a period of at least 1 week, making the patch applicable for being used in female contraception with the concept of administering the patch ones weekly.

Abstract: The present invention provides methods of determining whether a female patient will benefit from hormone replacement therapy.

Abstract: A decongestant composition is provided comprising: (a) a safe and effective amount of an adrenergic compound; (b) a safe and effective amount of a steroid; and (c) a pharmaceutically-acceptable carrier. Methods of treating congestion in a human or animal subject are also provided comprising administering to the subject a composition comprising: (a) an adrenergic compound; and (b) a steroid; where the daily dose of the adrenergic compound administered to the subject is from about 1 ?g to about 800 ?g, and the daily dose of the steroid administered to the subject is from about 1 ?g to about 400 ?g.

Abstract: Method and composition for treating psoriasis and other skin disorders.

Abstract: Estrogen and progesterone replacement therapies are provided herein. Among others, the following formulations are provided herein: solubilized estradiol without progesterone; micronized progesterone without estradiol; micronized progesterone with partially solubilized progesterone; solubilized estradiol with micronized progesterone; solubilized estradiol with micronized progesterone in combination with partially solubilized progesterone; and solubilized estradiol with solubilized progesterone.

Abstract: Estrogen and progesterone replacement therapies are provided herein. Among others, the following formulations are provided herein: solubilized estradiol without progesterone; micronized progesterone without estradiol; micronized progesterone with partially solubilized progesterone; solubilized estradiol with micronized progesterone; solubilized estradiol with micronized progesterone in combination with partially solubilized progesterone; and solubilized estradiol with solubilized progesterone.

Abstract: Estrogen and progesterone replacement therapies are provided herein. Among others, the following formulations are provided herein: solubilized estradiol without progesterone; micronized progesterone without estradiol; micronized progesterone with partially solubilized progesterone; solubilized estradiol with micronized progesterone; solubilized estradiol with micronized progesterone in combination with partially solubilized progesterone; and solubilized estradiol with solubilized progesterone.

Abstract: Estrogen and progesterone replacement therapies are provided herein. Among others, the following formulations are provided herein: solubilized estradiol without progesterone; micronized progesterone without estradiol; micronized progesterone with partially solubilized progesterone; solubilized estradiol with micronized progesterone; solubilized estradiol with micronized progesterone in combination with partially solubilized progesterone; and solubilized estradiol with solubilized progesterone.

Abstract: Estrogen and progesterone replacement therapies are provided herein. Among others, the following formulations are provided herein: solubilized estradiol without progesterone; micronized progesterone without estradiol; micronized progesterone with partially solubilized progesterone; solubilized estradiol with micronized progesterone; solubilized estradiol with micronized progesterone in combination with partially solubilized progesterone; and solubilized estradiol with solubilized progesterone.

Abstract: Estrogen and progesterone replacement therapies are provided herein. Among others, the following formulations are provided herein: solubilized estradiol without progesterone; micronized progesterone without estradiol; micronized progesterone with partially solubilized progesterone; solubilized estradiol with micronized progesterone; solubilized estradiol with micronized progesterone in combination with partially solubilized progesterone; and solubilized estradiol with solubilized progesterone.

Abstract: By lowering and then after raising the amount of SHBG in the body, an effective method for treatment of various diseases is achieved. First and seconds androgens, namely, anabolic steroids are used to both lower the SHBG and, thereafter raise the testosterone in the body until equilibrium between the SHBG and the second steroid, to normalize the FAI. Stanozolol is the preferred anabolic steroid used herein to lower the SHBG and testosterone is used to normalize the FAI.

Abstract: Estrogen and progesterone replacement therapies are provided herein. Among others, the following formulations are provided herein: solubilized estradiol without progesterone; micronized progesterone without estradiol; micronized progesterone with partially solubilized progesterone; solubilized estradiol with micronized progesterone; solubilized estradiol with micronized progesterone in combination with partially solubilized progesterone; and solubilized estradiol with solubilized progesterone.

Abstract: This invention relates to a method of preventing pregnancy and treating PMS including PMDD. More particularly, the invention relates to a method, which involves administering one of several combination oral contraceptive regimens in combination with an antidepressant and a kit containing the same.

Abstract: Provided herein are methods for preventing or alleviating the symptoms of and inflammation associated with inflammatory diseases and conditions of the gastrointestinal tract, for example, those involving the esophagus. Also provided herein are pharmaceutical compositions useful for the methods of the present invention.

Abstract: The present invention provides a compound which is an inhibitor of sphingolipid biosynthesis for use in the treatment of a disease which has a secondary Niemann-Pick type C disease like cellular phenotype.