Abstract: A method for rapid delivery of an active compound to innervate a cranial nerve of a subject. Also provided is a method for treating a disease or condition by topically applying a pharmaceutical composition to the face excluding the palpebral part of the eye, in an amount effective for treating the disease or condition.

Abstract: Synthetic methods for preparing deoxycholic acid and intermediates thereof, high purity synthetic deoxycholic acid, compositions and methods of use are provided. Also, provided are processes for the synthesis of 12-keto or 12-?-hydroxysteroids from ?-9,11-ene, 11-keto or 11-hydroxy-?-steroids. This inversion is also directed to novel compounds prepared during the synthesis. This invention is also directed to the synthesis of deoxycholic acid starting from hydrocortisone.

Abstract: The present invention relates to pharmaceutical compositions comprising a combination of a therapeutically-effective amount of the antiviral compound acyclovir and a therapeutically-effective amount of the COX-2 inhibitor meloxicam. The invention is further related to methods of treating functional somatic syndromes by administering a therapeutically-effective combination of acyclovir and meloxicam.

Abstract: The present invention relates to pharmaceutical compositions comprising a combination of a therapeutically-effective amount of the antiviral compound valacyclovir and a therapeutically-effective amount of the COX-2 inhibitor diclofenac. The invention is further related to methods of treating functional somatic syndromes by administering a therapeutically-effective combination of valacyclovir and diclofenac.

Abstract: The present invention relates to methods for reducing testosterone levels in a male subject and methods of treating, suppressing, reducing the incidence, reducing the severity, or inhibiting prostate cancer, advanced prostate cancer, castration resistant prostate cancer (CRPC), metastatic castration resistant prostate cancer (mCRPC), and methods of reducing high or increasing PSA levels and/or increasing SHBG levels in a subject suffering from prostate cancer, advanced prostate cancer, castration resistant prostate cancer (CRPC) and metastatic castration resistant prostate cancer (mCRPC). The compounds of this invention suppress free or total testosterone levels despite castrate levels secondary to ADT and reduce high or increasing PSA levels. This reduction in testosterone levels may be used to treat prostate cancer, advanced prostate cancer, CRPC and mCRPC without causing bone loss, decreased bone mineral density, increased risk of bone fractures, increased body fat, hot flashes and/or gynecomastia.

Abstract: The present invention is directed generally to pharmaceutical compositions, methods, and kits for improving side effects associated with aromatase inhibitor treatment in a subject diagnosed with breast cancer. More specifically, the present invention provides compositions, methods, and kits comprising an aromatase inhibitor and an androgenic agent.

Abstract: A topical cream applied to a nipple of a lactating female induces lactation. The cream comprises a base cream having from about 0.5% to about 10%, by volume, of a steroid, based upon the total volume of the cream. The preferred steroid is stanozolol. Preferably, the cream comprises at least about 1% to about 10%, by volume, of stanozolol, based on the total volume of the cream.

Abstract: Disclosed herein are compositions and methods for the treatment or prophylaxis of a subject having or susceptible to a kidney disease. The method includes the step of administering to the subject a compound of formula (I) in a dose of about 1 to 10 mg/Kg to improve the glomerular filtration rate (GFR) of the subject for at least 4 folds as compared to the GFR of the subject before treatment, The method further includes the step of administering to the subject an effective amount of lucidenic acid C (LAC), lucidenic acid N (LAN), lucidenic acid E2 (LAE2), lucidenic acid A (LAA), and lucidenic acid D2 (LAD2).

Abstract: The invention relates to methods for the treatment of fibromyalgia and chronic fatigue syndrome by administration of a transdermally applied androgen composition. The treatment is both safe and effective for treating fibromyalgia-related pain and fatigue, as well as chronic fatigue syndrome.

Abstract: This invention provides a preparation of a powdered plant sterol ester which comprises a plant sterol ester, an octenyl succinate-modified starch and an indigestible dextrin. The preparation can be prepared by a method comprising the steps of emulsifying a plant sterol ester in an aqueous solution containing an octenyl succinate-modified starch and an indigestible dextrin to form an emulsion and then powdering the resulting emulsion. The invention permits the application of plant sterol esters to wide variety of foods and drinks. In addition, the invention permits the effective control of an increase of the serum-cholesterol content accompanied by the intake of meals.

Abstract: The present invention provides for bioavailable oral dosage forms containing esters of 17-hydroxyprogesterone as well as related methods. The oral dosage forms can be formulated for pregnancy support and can include a therapeutically effective amount of an ester of 17-hydroxyprogesterone and a pharmaceutically acceptable carrier. In another embodiment, a pharmaceutically acceptable oral dosage form for pregnancy support is provided. The pharmaceutically acceptable oral dosage can include a therapeutically effective amount of an ester of 17-hydroxyprogesterone and a pharmaceutically acceptable carrier. The oral dosage form can, when measured using a USP Type-II dissolution apparatus in 900 mL of deionized water with 0.5 (w/v) of sodium lauryl sulfate at 50 RPM at 37° C., release at least 20 wt % of the dose of the ester of 17-hydroxyprogesterone after 60 minutes, or in the alternative release at least 20 wt % more after 60 minutes than an equivalently dosed oral dosage form without the carrier.

Abstract: The present invention provides for bioavailable oral dosage forms containing esters of 17-hydroxyprogesterone as well as related methods. The oral dosage forms can be formulated for pregnancy support and can include a therapeutically effective amount of an ester of 17-hydroxyprogesterone and a pharmaceutically acceptable carrier. In another embodiment, a pharmaceutically acceptable oral dosage form for pregnancy support is provided. The pharmaceutically acceptable oral dosage can include a therapeutically effective amount of an ester of 17-hydroxyprogesterone and a pharmaceutically acceptable carrier. The oral dosage form can, when measured using a USP Type-II dissolution apparatus in 900 mL of deionized water with 0.5 (w/v) of sodium lauryl sulfate at 50 RPM at 37° C., release at least 20 wt % of the dose of the ester of 17-hydroxyprogesterone after 60 minutes, or in the alternative release at least 20 wt % more after 60 minutes than an equivalently dosed oral dosage form without the carrier.

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 for managing the risk of an adverse interaction between teriflunomide and a substrate of breast cancer resistance protein (BCRP) and/or organic anion transporting polypeptide B1 and B3 (OATP1B1/B3).

Abstract: The invention relates to a method of contraception, which method comprises administering to a woman in need thereof an emergency contraception during one or two days, followed by a prolonged low dosage contraceptive treatment until next menstrual period.

Abstract: The disclosure relates to novel C4 and C6 substituted androst-4-ene diones as well as andros-1,4-diene diones and derivatives thereof, their process of preparation, pharmaceutical compounds containing them, and the use of said compounds for the treatment of hormone-related disorders in mammals. This includes hormone-dependent cancers, particularly those caused by elevated levels of estrogen and its intermediates. These compounds can also be used in the treatment of other hormone-related disorders, including benign prostatic hyperplasia, cardiovascular disease, and neurodegenerative disorders.

Abstract: The present invention relates to novel genetic markers associated with endometriosis and risk of developing endometriosis, and methods and materials for determining whether a human subject has endometriosis or is at risk of developing endometriosis and the use of such risk information in selectively administering a treatment that at least partially prevents or compensates for an endometriosis related symptom.

Abstract: The present invention is directed to compositions and methods suitable for the treatment of alopecia by topical application include minoxidil sulfate, finasteride, and 17?-estradiol. The combination is characterized by low alcohol content to minimize skin irritation and may be enhanced with the addition of vitamins, minerals, and peptides. The topical use of this combination leads to a lower overall risk of side effects than orally administered drugs.

Abstract: The present invention relates to a combination of resveratrol with progestogen, and medicaments and pharmaceutical compositions containing the same, which are useful in the treatment and/or prevention of myoma and/or endometriosis, providing their size reduction and the control of related symptoms. Said association may additionally comprise an estrogen component. A treatment method and a kit are also objects of this invention.

Abstract: Compositions and methods for alleviating the symptoms associated with chronic fatigue syndrome and fibromyalgia syndrome are provided. The compositions are based on use of a transdermal gel formulation delivery system for androgens, either alone or in combination with other hormones.

Abstract: The present invention relates to a very low-dosed dosage form for hormone replacement therapy (HRT). More particularly, the present invention concerns a solid oral dosage form comprising about 0.5 mg estradiol and about 0.25 mg drospirenone, and at least one pharmaceutically acceptable excipient. Despite the very low E2 and DRSP doses it has surprisingly been found that a high proportion of the women suffering from moderate to severe hot flushes actually respond to this treatment. Accordingly, the dosage form of the invention may be used as maintenance HRT or may be used already when HRT is initiated.

Abstract: Novel sterol derivatives, the preparation method thereof, pharmaceutical compositions containing them and use thereof for treating diseases involving transformed astrocyte cells or for treating malignant haemopathies. The treatment of glioblastoma multiforme, as well as of other cancers, such as lymphomas, neuroblastomas and melanomas is also described.

Abstract: A unified homeostatic system of cholesterol and steroid hormone pathways is described, in which the uses or modulations of function of the homeostatic system of cholesterol and steroid hormone pathways are linked by lipoproteins, and are used or modulated to achieve a therapeutic benefit, to diagnose a disease or medical condition in humans, or to develop suitable active agents or combinations of active agents. Pharmaceutical compositions, methods of treatment, methods of drug development, and assay methods that rely on the new understanding of the homeostatic system are described.

Abstract: The present invention is related to a dosage regimen of a steroid sulfatase inhibitor, E2MATE, for use in the prevention or treatment of endometriosis. The present invention further relates to a method for preventing or treating endometriosis.

Abstract: The disclosure relates to novel C4 and C6 substituted androst-4-ene diones as well as andros-1,4-diene diones and derivatives thereof, their process of preparation, pharmaceutical compounds containing them, and the use of said compounds for the treatment of hormone-related disorders in mammals. This includes hormone-dependent cancers, particularly those caused by elevated levels of estrogen and its intermediates. These compounds can also be used in the treatment of other hormone-related disorders, including benign prostatic hyperplasia, cardiovascular disease, and neurodegenerative disorders.

Abstract: The invention relates to a pharmaceutical composition comprising liposomes composed of non-charged vesicle-forming lipids, optionally including not more than 10 mole percent of negatively charged vesicle-forming lipids and/or not more than 10 mole percent of PEGylated lipids, the liposomes having a selected mean particle diameter in the size range of 40-200 nm and comprising a first corticosteroid in water soluble form, for the site-specific treatment of inflammatory disorders in humans, providing in human patients a fast, strong, and durable anti-inflammatory effect for at least 2 weeks at a dose of at most 5 mg/kg body weight of prednisolone or an equipotent dose corticosteroid other than prednisolone at a treatment frequency of at most once per two weeks.

Abstract: The present invention discloses administering steroid hormones to mammals to treat autoimmune related diseases, including post-partum auto immune diseases. Most preferably the invention uses estrogens, estranges, estriol or estrogen receptor active agents to prevent or ameliorate clinical symptoms of these Th1-mediated (cell-mediated) autoimmune diseases known to either have an initial onset following the birth of a child or which are exacerbated in patients in the post-partum period.

Abstract: The present invention provides methods and compositions for the treatment of fluid accumulation in and/or under the retina.

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 provides for bioavailable oral dosage forms containing esters of 17-hydroxyprogesterone as well as related methods. The oral dosage forms can be formulated for pregnancy support and can include a therapeutically effective amount of an ester of 17-hydroxyprogesterone and a pharmaceutically acceptable carrier. In another embodiment, a pharmaceutically acceptable oral dosage form for pregnancy support is provided. The pharmaceutically acceptable oral dosage can include a therapeutically effective amount of an ester of 17-hydroxyprogesterone and a pharmaceutically acceptable carrier. The oral dosage form can, when measured using a USP Type-II dissolution apparatus in 900 mL of deionized water with 0.5 (w/v) of sodium lauryl sulfate at 50 RPM at 37° C., release at least 20 wt % of the dose of the ester of 17-hydroxyprogesterone after 60 minutes, or in the alternative release at least 20 wt % more after 60 minutes than an equivalently dosed oral dosage form without the carrier.

Abstract: A transdermal hormone delivery system (THDS) is disclosed. The THDS is useful for control of fertility and as therapy for a variety of diseases and conditions treatable by robust delivery of progestin and estrogen hormones, particularly the progestin, levonorgestrel. The THDS comprises a backing layer, an adjoining adhesive polymer matrix comprising an effective amount of at least a progestin hormone, delivery of which is enhanced by one or more skin permeation enhancing agents present in pre-determined amounts. The THDS is capable of providing effective daily doses of progestin and estrogen hormones from a small surface area in contact with the skin, e.g., less than 20 square centimeters. Methods of fertility control and various types of hormone replacement therapy utilizing the THDS are also disclosed.

Abstract: The present invention provides an improved method to deliver estrogen to menopausal women comprising administering ultra-low dose estradiol alternating with standard-dose estradiol.

Abstract: Pharmaceutical formulations for co-administering estradiol and progesterone are provided herein. In some embodiments, the formulation comprises solubilized estradiol, suspended progesterone, and a medium chain (C6-C12) oil.

Abstract: The invention relates to hormone containing oil-in-water emulsion for parenteral administration comprising progestogen and/or estrogen; a phospholipid comprising one or two omega-3 fatty acid moieties; and an oil as well as a pharmaceutical composition comprising or consisting of said oil-in-water emulsion. The pharmaceutical is especially for use in the treatment or prophylaxis of neurological damage after strokes and/or trauma and/or for use in the treatment or prophylaxis of neurological damage after concussion and/or traumatic injury to the central nervous system.

Abstract: The present invention relates to a hormone containing oil-in-water emulsion for parenteral administration comprising a) progestogen and/or estrogen and b) fish oil triglycerides, wherein the fish oil triglyceride consists of glycerol which is esterified with fatty acids wherein said fatty acids comprise eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in an amount of at least 45% by weight of said fatty acids.

Abstract: Methods are directed to the treatment of subjects with prostate cancer, in particular those with castration resistant prostate cancer, with glucocorticoid receptor antagonists. The prostate cancer may be one that has become resistant to androgen deprivation therapy, for example, by increase in glucocorticoid receptor expression and/or activity.

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: 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: The present application relates to a method for obtaining a mixture of estrogens from the pregnant mare's urine.

Abstract: Compositions and methods for treating esophageal diseases are disclosed. More specifically, these methods may refer to the treament of esophageal varices and eosinophilic esophagitis using an oral suspension drug for humans. The oral suspension drug may include poloxamer f127 used as vehicle and budesonide as a corticosteroid. Poloxamer oral suspension may be administrated by swallowing the poloxamer oral suspension drug which may slide down through the esophageal and may be adhered in the affected site providing a longer residence time. Additionally, poloxamer oral suspension may be mixed with APIs such as antifungals, antibacterials, and corticosteroids, previously dissolved in a suitable liquid, such as water.

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: Prodrugs of C-17-heterocyclic-steroidal drugs providing improved oral bioavailability and phamacokinetics are described. The drugs are inhibitors of human CYP 17 enzyme, as well as potent antagonists of both wild type and mutant androgen receptors (AR), and are useful for the treatment of urogenital and/or androgen-related cancers, diseases and/or conditions, such as human prostate cancer, breast cancer, and prostate hyperplasia. The disclosure describes methods of synthesizing and using the prodrugs in cancer therapy.

Abstract: The present invention relates to a very low-dosed dosage form for hormone replacement therapy (HRT). More particularly, the present invention concerns a solid oral dosage form comprising about 0.5 mg estradiol and about 0.25 mg drospirenone, and at least one pharmaceutically acceptable excipient. Despite the very low E2 and DRSP doses it has surprisingly been found that a high proportion of the women suffering from moderate to severe hot flushes actually respond to this treatment. Accordingly, the dosage form of the invention may be used as maintenance HRT or may be used already when HRT is initiated.

Abstract: Disclosed herein is a composition that includes a novel combination of triterpenoids for the treatment or prophylaxis of a cancer. The triterpenoids includes at least ganoderic acid S (GAS), ganoderic acid T (GAT), ganoderic acid Me (GAMe), ganoderic acid R (GAR), and ganodermic acid S (GMAS). The composition is suitable for the treatment or prophylaxis of colon cancer, hepatic cancer, breast cancer, lung cancer or leukemia.

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 a topical pharmaceutical composition that comprises the combination of an antimicrobial, a glucocorticoid, an antimycotic and pharmaceutically acceptable vehicles or excipients; the method for producing the composition and the use of said composition for treating localized dermatosis ailments.

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: The invention relates to methods for the treatment of fibromyalgia and chronic fatigue syndrome by administration of a transdermally applied androgen composition. The treatment is both safe and effective for treating fibromyalgia-related pain and fatigue, as well as chronic fatigue syndrome.