Abstract: Pharmaceutical compositions and stable nano-suspensions comprising mifepristone and at least one pharmaceutically acceptable excipient, which exhibit enhanced bioavailability compared to the currently marketed or commercially available formulations. Manufacturing process and methods of use are also provided. The pharmaceutical compositions are used for prevention, treatment or prophylaxis of disorders in human patients in need thereof. Oral pharmaceutical compositions of mifepristone, methods for their administration, processes for thei r production, and use of these compositions are described for the treatment of diseases for which mifepristone is indicated.

Abstract: The invention relates to a method of diagnosing or screening for 27-hydroxylase (CYP27A1) deficiency in an animal comprising: determining in a biological sample the intensity signal by mass analysis of at least a bile alcohol glucuronide and a C24- or C27-bile acid or a conjugate thereof, comparing the intensity signals to a control sample or control value, and determining 27-hydroxylase (CYP27A1) deficiency based on said comparison.

Abstract: A method for providing a steady state plasma concentration of about 20-400 ng/ml of isoflavonoid compounds comprising the steps of a first rectal administration of the compound in a lipophilic suppository base followed by further rectal administrations no earlier than 4, 8 or 16 hours after the previous rectal administration.

Abstract: A suspension includes an ophthalmic active ingredient suspended in a formulation vehicle including a suspending agent and a non-ionic cellulose derivative. The ophthalmic active agent is present as particles having Dv90<5 ?m and Dv50<1 ?m. The suspension may be administered to a patient for treating an ophthalmic inflammatory condition.

Abstract: The present invention generally provides systems and methods for the detection, identification, or characterization of differences between properties or behavior of corresponding species in two or more mixtures comprised of molecules, including biomolecules and/or molecules able to interact with biomolecules, using techniques such as partitioning. The experimental conditions established as distinguishing between the mixtures of the molecules using the systems and methods of the invention can also be used, in some cases, for further fractionation and/or characterization of the biomolecules and/or other molecules, using techniques such as single-step or multiple-step extraction, and/or by liquid-liquid partition chromatography. The methods could also be used for discovering and identifying markers associated with specific diagnostics, and can be used for screening for such markers once discovered and identified during diagnostics screening.

Abstract: Biodegradable polymer microparticles bearing a steroid drug and a preparation method therefor. In the method, a steroid drug and a biodegradable polyester-based polymer are dissolved in an organic solvent and sprayed into a low-temperature hydrocarbon solution to form frozen microparticles that are then immersed in a low-temperature, aqueous salt solution to deprive the microparticles of the organic solvent, thereby preparing biodegradable polymer microparticles bearing a steroid drug. The steroid drug or steroid sex hormone drug-bearing biodegradable polymer microparticles were found to have excellent biocompatibility, biodegradability, porosity, and mechanical strength and to release the steroid drug or steroid sex hormone drug for a long period of time.

Abstract: This invention relates the use of cortisol blockers (glucocorticoid receptor [GR] antagonists) for the treating or preventing treatment resistant prostate cancer, treating or preventing neoplasia, and treating or preventing infection related to acute or chronic injury or disease.

Abstract: Compositions and methods for treating or preventing E. coli infections are provided. The compositions can be formulated as pharmaceutical compositions or as disinfectants, sanitizers, detergents or antiseptics, and can be used to eradicate or reduce E. coli populations and thereby treat or prevent infection by E. coli. The compositions include one or more digestive enzymes, e.g., one or more protease, lipases, and amylases. Methods of use of the compositions are also provided.

Abstract: A composition for the treatment of cellulitis is provided that includes an antibiotic. The composition may also include an analgesic, an anaesthetic, or a combination thereof. A method use is also provided by which the composition is applied topically or to affected skin. A method of use is also provided prior to a medical procedure involving an incision through the skin of a patient in a predetermined area, the method including the application, to the predetermined area and prior to the procedure of the composition.

Abstract: The present invention is directed to orally administered corticosteroid compositions. The present invention also provides a method for treating a condition associated with inflammation of the gastrointestinal tract in an individual. The method comprises administering to an individual in need thereof a pharmaceutical composition of the present invention.

Abstract: The invention provides stabilized aqueous pharmaceutical etanercept compositions stabilized with an amino acid and suitable for long-term storage of etanercept, methods of manufacture of these compositions, methods of administration, and kits containing same.

Abstract: The present invention resides in the discovery that glucocorticoid receptor antagonists are effective for treating muscular dystrophy including type 1 or type 2 myotonic dystrophy. Treatment methods and kits are provided.

Abstract: A method that includes testing for the presence of a phosphorylated Ser294 (phospho-Ser294) progesterone receptor (PR). A method that includes determining the expression level of a gene in a patient sample and comparing it to a control sample.

Abstract: Particles, compositions, and methods that aid particle transport in mucus are provided. The particles, compositions, and methods may be used, in some instances, for ophthalmic and/or other applications. In some embodiments, the compositions and methods may involve modifying the surface coatings of particles, such as particles of pharmaceutical agents that have a low aqueous solubility. Such compositions and methods can be used to achieve efficient transport of particles of pharmaceutical agents though mucus barriers in the body for a wide spectrum of applications, including drug delivery, imaging, and diagnostic applications. In certain embodiments, a pharmaceutical composition including such particles is well-suited for ophthalmic applications, and may be used for delivering pharmaceutical agents to the front of the eye and/or the back of the eye.

Abstract: This invention concerns Selective Progesterone Receptor Modulators (SPRM) in a prodrug form as well as their application in therapy. (3?, 11?,17?)-1 1-[4-(methylsulfonyl)phenyl]-17-(pentafluoroethyl)estra-4,9-diene-3,17-diol (Compound 1) is one of the invention prodrugs.

Abstract: Particles, compositions, and methods that aid particle transport in mucus are provided. The particles, compositions, and methods may be used, in some instances, for ophthalmic and/or other applications. In some embodiments, the compositions and methods may involve modifying the surface coatings of particles, such as particles of pharmaceutical agents that have a low aqueous solubility. Such compositions and methods can be used to achieve efficient transport of particles of pharmaceutical agents though mucus barriers in the body for a wide spectrum of applications, including drug delivery, imaging, and diagnostic applications. In certain embodiments, a pharmaceutical composition including such particles is well-suited for ophthalmic applications, and may be used for delivering pharmaceutical agents to the front of the eye and/or the back of the eye.

Abstract: Particles, compositions, and methods that aid particle transport in mucus are provided. The particles, compositions, and methods may be used, in some instances, for ophthalmic and/or other applications. In some embodiments, the compositions and methods may involve modifying the surface coatings of particles, such as particles of pharmaceutical agents that have a low aqueous solubility. Such compositions and methods can be used to achieve efficient transport of particles of pharmaceutical agents though mucus barriers in the body for a wide spectrum of applications, including drug delivery, imaging, and diagnostic applications. In certain embodiments, a pharmaceutical composition including such particles is well-suited for ophthalmic applications, and may be used for delivering pharmaceutical agents to the front of the eye and/or the back of the eye.

Abstract: The present invention provides compositions and methods for treating a subject in need of treatment with testosterone, including introducing testosterone into the subject subcutaneously, intradermally, or intramuscularly, from a needle assisted jet injection device.

Abstract: The present disclosure provides a pharmaceutical preparation of a compound of formula (I) or a stereoisomer, pharmaceutically acceptable salt, or prodrug thereof. The present disclosure further provides a method for general anesthesia or sedation for mammals. Also provided are kits and manufactured products of the medicament and the pharmaceutical composition and a method for using the medicament and the pharmaceutical composition.

Abstract: Particles, compositions, and methods that aid particle transport in mucus are provided. The particles, compositions, and methods may be used, in some instances, for ophthalmic and/or other applications. In some embodiments, the compositions and methods may involve modifying the surface coatings of particles, such as particles of pharmaceutical agents that have a low aqueous solubility. Such compositions and methods can be used to achieve efficient transport of particles of pharmaceutical agents though mucus barriers in the body for a wide spectrum of applications, including drug delivery, imaging, and diagnostic applications. In certain embodiments, a pharmaceutical composition including such particles is well-suited for ophthalmic applications, and may be used for delivering pharmaceutical agents to the front of the eye and/or the back of the eye.

Abstract: Particles, compositions, and methods that aid particle transport in mucus are provided. The particles, compositions, and methods may be used, in some instances, for ophthalmic and/or other applications. In some embodiments, the compositions and methods may involve modifying the surface coatings of particles, such as particles of pharmaceutical agents that have a low aqueous solubility. Such compositions and methods can be used to achieve efficient transport of particles of pharmaceutical agents though mucus barriers in the body for a wide spectrum of applications, including drug delivery, imaging, and diagnostic applications. In certain embodiments, a pharmaceutical composition including such particles is well-suited for ophthalmic applications, and may be used for delivering pharmaceutical agents to the front of the eye and/or the back of the eye.

Abstract: Particles, compositions, and methods that aid particle transport in mucus are provided. The particles, compositions, and methods may be used, in some instances, for ophthalmic and/or other applications. In some embodiments, the compositions and methods may involve modifying the surface coatings of particles, such as particles of pharmaceutical agents that have a low aqueous solubility. Such compositions and methods can be used to achieve efficient transport of particles of pharmaceutical agents though mucus barriers in the body for a wide spectrum of applications, including drug delivery, imaging, and diagnostic applications. In certain embodiments, a pharmaceutical composition including such particles is well-suited for ophthalmic applications, and may be used for delivering pharmaceutical agents to the front of the eye and/or the back of the eye.

Abstract: Provided herein is an ophthalmic composition including a therapeutic active agent and an anti-inflammatory agent, in which the active agent is at least about 0.01% w/v of chlorhexidine, derivatives, or analogues of chlorhexidine, or a pharmaceutically acceptable salt, solvent, hydrate, or polymorph thereof. Methods for treating or preventing ocular disease or infection in a subject in need thereof are also provided. The method may include administering to an eye of a subject an ophthalmic composition including chlorhexidine, derivatives, or analogues of chlorhexidine, or a pharmaceutically acceptable salt, solvent, hydrate, or polymorph thereof, and an anti-inflammatory agent. The chlorhexidine, derivatives, or analogues of chlorhexidine, or a pharmaceutically acceptable salt, solvent, hydrate, or polymorph thereof and the anti-inflammatory agent are present in an amount effective to treat or prevent the ocular disease or infection in a subject in need thereof.

Abstract: The disclosure teaches precisely engineered biodegradable drug delivery systems and methods of making and utilizing such systems. In aspects, the biodegradable drug delivery systems taught herein comprise intravitreal ocular implants suitable for delivery of corticosteroids to the posterior segment of a human eye. The intravitreal ocular implants described herein have a desired extended drug release profile suitable for treating inflammation of the human eye.

Abstract: Provided herein is an ophthalmic composition including a therapeutic active agent and an anti-inflammatory agent, in which the active agent is at least about 0.01% w/v of chlorhexidine, derivatives, or analogues of chlorhexidine, or a pharmaceutically acceptable salt, solvent, hydrate, or polymorph thereof. Methods for treating or preventing ocular disease or infection in a subject in need thereof are also provided. The method may include administering to an eye of a subject an ophthalmic composition including chlorhexidine, derivatives, or analogues of chlorhexidine, or a pharmaceutically acceptable salt, solvent, hydrate, or polymorph thereof, and an anti-inflammatory agent. The chlorhexidine, derivatives, or analogues of chlorhexidine, or a pharmaceutically acceptable salt, solvent, hydrate, or polymorph thereof and the anti-inflammatory agent are present in an amount effective to treat or prevent the ocular disease or infection in a subject in need thereof.

Abstract: This invention provides for a method of treating secondary adrenal insufficiency by co-administrating therapeutically effective amounts of a glucocorticoid and a glucocorticoid receptor antagonist to the patient in need thereof. In some embodiments, the method includes the proviso that the patient not be otherwise in need of treatment with a glucocorticoid and a glucocorticoid receptor antagonist. The treatment method can increase the patient's morning or basal cortisol level to at least about 12 ?g/dL or a standard control level, and in turn, expedite significantly the recovery of the HPA axis. The method provided herein can improve health outcomes and life-threatening complications associated with secondary adrenal insufficiency.

Abstract: A formulation for drug delivery, providing enhanced modulation of solubility, stability, absorption, metabolism, and/or pharmacokinetic profile of a lipophilic therapeutic agent by formulation with sterols and/or sterol esters, resulting in higher bioavailability of a therapeutic agent administered to a subject in need of such therapeutic agent. The formulation contains a therapeutic agent and a sterol or sterol ester, and can, optionally, further contain a solubilizer and/or an enhancing agent. Also described are pharmaceutical compositions containing the formulations and methods of making and methods of using the formulations and pharmaceutical compositions. Formulations of the disclosure can be constituted to minimize the synthesis of dihydrotestosterone when the therapeutic agent includes testosterone or testosterone esters.

Abstract: The invention is directed to methods and compositions for curing migraine headaches. In particular, compositions are described involving the combination of dexamethasone, lidocaine, and thiamine. The compositions are administered to patients having migraines having trigeminal or occipital neuralgia by subcutaneous injection during a single treatment session, a combination of dexamethasone, lidocaine and thiamine to several craniofacial nerves.

Abstract: The present invention relates generally to gynecological diseases and in particular to a method for reducing pain associated with dislocation of basal endometrium.

Abstract: Methods of using 7?,11?-dimethyl-17?-hydroxy-4-estren-3-one bucyclate (I) and 7?,11?-dimethyl-17?-hydroxyestr-4-en-3-one 17-undecanoate (II) for various hormonal therapies, dosage forms comprising 7?,11?-dimethyl-17?-hydroxy-4-estren-3-one bucyclate and 7?,11?-dimethyl-17?-hydroxyestr-4-en-3-one 17-undecanoate, and processes for their preparation.

Abstract: Provided herein are methods for treating, 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 relates generally to compositions and methods of using the same. A first aspect of the present invention comprises a composition comprising a first viscosity increasing agent; at least one polyhydric alcohol; at least one buffering agent; at least one preservative; a second viscosity increasing agent; at least one organic solvent; at least one humectant; at least one active pharmaceutical ingredient; and water, wherein the composition is buffered to a pH of about 3 to about 11.

Abstract: The present invention relates to antagonists or inhibitors, which bind selectively to RANKL/OPGbp and regulate the interaction between RANKL/OPGbp and RANK/OPG. In particular, the present invention relates to an antibody or antigen binding domain, fragment or derivative thereof, immunoreactive with a RANKL/OPGbppeptide for use in the treatment, prevention or alleviation of male infertility or reduced male fertility such as oligospermia or azospermia.

Abstract: The present invention provides treatment of fatty liver disease using a class of pyrimidinedione cyclohexyl compounds.

Abstract: Methods for modulating inflammation using progesterone metabolites are disclosed. More particularly, methods of administering progesterone metabolites, 6?-hydroxyprogesterone (6?-OHP) and 16?-hydroxyprogesterone (16?-OHP) are disclosed for mitigating inflammation in various tissue types in the body.

Abstract: The invention generally relates to the use of nuclear transport modulators, e.g., CRM1 inhibitors, and more particularly to a compound represented by structural formula I: or a pharmaceutically acceptable salt thereof, wherein Ring A, X, R1, R2 and n are as defined and described herein, in a method for promoting wound healing in a subject.

Abstract: Applicant provides methods of treating diseases including Cushing's syndrome and hormone-sensitive cancers by concomitant administration of a glucocorticoid receptor antagonist (GRA) and steroidogenesis inhibitors, and by concomitant administration of a GRA and CYP3A inhibitors. Applicant provides methods of treating diseases including Cushing's syndrome and hormone-sensitive cancers by concomitant administration of mifepristone and ketoconazole. Subjects treated with CYP3A inhibitors or steroidogenesis inhibitors may suffer from toxicity or other serious adverse reactions; concomitant administration of other drugs would be expected to increase the risk of such toxicity and adverse reactions.

Abstract: Injectable pharmaceutical compositions, methods of use and formulation are disclosed. The compositions comprise: one or more water soluble complexes, each complex comprising a cyclodextrin or a cyclodextrin derivative and a hydrophobic drug; at least one preservative; and at least one co-solvent. The compositions are effectively preserved in accordance with the European Pharmacopoeia 2011 Test for Efficacy of Antimicrobial Preservation, satisfying at least the B criteria as it applies to parenterals, and the United States Pharmacopeia 2011 Guidelines for Antimicrobial Effectiveness Testing, satisfying the criteria for Category 1 (injectable) products.

Abstract: The present invention relates to pharmaceutical compositions comprising 4-pregenen-11?-17-21-triol-3,20-dione derivatives, and their use as pharmaceuticals as modulators of the glucocorticoid receptors (GR) and/or the mineralocorticoid receptors (MR). The invention relates specifically to the use of these compounds and their pharmaceutical compositions to treat ocular conditions associated with the glucocorticoid receptors (GR) and/or the mineralocorticoid receptors (MR).

Abstract: The invention relates to 17-hydroxy-17-pentafluoroethyl-estra-4,9(10)-dien-11-aryl derivatives of Formula I with progesterone antagonizing action and method of production thereof, use thereof for the treatment and/or prophylaxis of diseases and use thereof for the production of medicinal products for the treatment and/or prophylaxis of diseases, in particular of fibroids of the uterus (myomas, uterine leiomyoma), endometriosis, heavy menstrual bleeds, meningiomas, hormone-dependent breast cancers and complaints associated with the menopause or for fertility control and emergency contraception.

Abstract: Formulations and methods for providing progestin-only contraception to a woman while minimizing various side effects, such as breakthrough bleeding, that are normally associated with progestin-only contraception are disclosed and described. In one aspect, the method can include transdermally administering a formulation having a contraceptively effective amount of a single progestin as the sole active hormonal agent to the woman as part of a contraceptive regimen.

Abstract: Model and method of treating inflammatory diseases. Traditional treatments for such diseases include administering to the patient toxic anti-inflammatory drugs. Following stabilization of the symptoms, the drug doses are tapered down to minimize side effects, as a result of which inflammation remains high and the disease is rarely cured. A chemistry-based disease model concludes that irrespective of the role that inflammation plays in the disease, inflammation reduction will impede disease initiation and progression. Managing and controlling inflammatory diseases requires reducing inflammation to acceptable normal values. Non-toxic ways such as non-steroidal anti-inflammatory drugs, anti-inflammatory diets, and regular exercise allow such reduction in inflammation to normal values, thereby slowing down or arresting disease progression and allowing the discontinuation or reduction of toxic anti-inflammatory therapy while maintaining low inflammation using non-toxic therapy.

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: The present invention relates to compounds and methods which may be useful as treatments of neuromuscular diseases such as muscular dystrophy, and as inhibitors of NF-?B for the treatment or prevention of muscular wasting disease, including muscular dystrophy.

Abstract: Disclosed are methods and pharmaceutical compositions for treating diseases, disorders, and conditions associated with glucocorticoid receptor (GR) expression and activity. The disclosed methods typically include administering to a patient in need thereof a glucocorticoid receptor (GR) agonist and administering to the patient in need thereof a REDD1 inhibitor that inhibits expression or activity of REDD1, wherein the REDD1 inhibitor is administered before, concurrently with, or after the GR agonist is administered.

Abstract: The present invention provides compounds of Formula (I) or (II), which are thought to be able to inhibit mTOR (mammalian target of rapamycin) signaling pathway, induce UPR (unfolded protein response), and/or perturb mitochondrial function of a cyst cell (e.g., a cyst cell causing polycystic kidney disease (PKD, e.g., autosomal dominant PKD (ADPKD) or autosomal recessive PKD (ARPKD)) or polycystic liver disease (PLD, e.g., autosomal dominant PLD (ADPLD) or autosomal recessive PLD (ARPLD)). The invention also provides pharmaceutical compositions, kits, and methods involving the compounds described herein for use in treating PKD or PLD, inhibiting the growth of a cyst cell, and/or killing a cyst cell.

Abstract: Provided is a transdermal drug delivery system, which is a delivery system for transdermal absorption, having a multi-lamellar emulsion structure, including: lipids including long-chain amides, sterols, fatty acid and fatty alcohol; an emulsifier; oil; and at least one drug for transdermal administration. The transdermal drug delivery system in a multi-lamellar emulsion structure, according to the present invention, has a lamellar structure in which a layered structure visible in stratum corneum intercellular lipids of the human body is repeated, and thus has an excellent skin barrier effect and enables a drug to be effectively partitioned through skin lipids, thereby obtaining an excellent drug delivery effect.

Abstract: Disclosed herein are markers whose mutational status is associated with sensitivity to treatment with NAE inhibitors. Mutational status is determined by measurement of characteristics of markers associated with the marker genes. Compositions and methods are provided to assess markers of marker genes to predict response to NAE inhibition treatment.

Abstract: The present invention provides a method for treating diabetes, hyperlipidemia or hepatic total lipids by using ergostatrien-3?-ol and its derivatives, as well as a method for decreasing blood glucose and HbA1c levels and reducing blood total cholesterol and triglyceride levels, whereas increasing blood HDL-C levels; and a method for decreasing hepatic total lipid and triacylglycerol levels; and increasing expression levels of membrane glucose transporter 4 (GLUT4) and phospho-Akt in skeletal muscle tissue, and phospho-AMPK in both skeletal muscle and liver tissue using ergostatrien-3?-ol and its derivatives.

Abstract: Compositions are provided that provide release of insect repellant or fragrance over an extended period of time. The compositions comprise a hydrophilically-modified cross-linked silicone elastomer and an acrylic rheology modifier.