Abstract: The present disclosure relates to compositions, kits, uses, systems and methods for treating overweight and obesity using naltrexone plus bupropion, preferably in combination with a comprehensive web-based and/or telephone-based weight management program, and preferably in subjects at increased risk of adverse cardiovascular outcomes.

Abstract: Dosage forms, drug delivery systems, and methods related to sustained release of dextromethorphan or improved therapeutic effects are disclosed. Typically, bupropion or a related compound is orally administered to a human being to be treated with, or being treated with, dextromethorphan.

Abstract: An abuse deterrent pharmaceutical composition including an acid soluble salt of a pharmaceutically active ingredient and a buffering ingredient; wherein the acid soluble salt of the pharmaceutically active ingredient and the buffering ingredient retard release of the pharmaceutically active ingredient when the composition is ingested in excess of an intended dosage.

Abstract: An abuse deterrent pharmaceutical composition including a pharmaceutically active ingredient; an acid soluble ingredient; and a buffering ingredient; wherein the acid soluble ingredient and the buffering ingredient retard release of the active pharmaceutical ingredient when the composition is ingested in excess of an intended dosage.

Abstract: A tableted pharmaceutical composition contains nalfurafine or a pharmaceutically acceptable acid addition salt thereof and is excellent in formability and quality control of related substances. The tableted pharmaceutical composition includes nalfurafine or a pharmaceutically acceptable acid addition salt thereof, a binder component, and a carrier, wherein the above mentioned nalfurafine or a pharmaceutically acceptable acid addition salt thereof is contained in an amount of 0.1 to 10 ?g, and the weight of the above mentioned binder component is 100,000 to 2,000,000 weight % based on the weight of the above mentioned nalfurafine or a pharmaceutically acceptable acid addition salt thereof and 5 to 20 weight % based on the total weight of the resulting pharmaceutical composition, or 20,000 to 500,000 weight % and 1 to 5 weight % based on the total weight of the resulting pharmaceutical composition.

Abstract: Provided are immediate or prolonged administration of certain salts of KATP channel openers such as diazoxide to a subject to achieve novel pharmacodynamic, pharmacokinetic, therapeutic, physiological, metabolic and compositional outcomes in the treatment of diseases or conditions involving KATP channels. Also provided are pharmaceutical formulations, methods of administration and dosing of the salts that achieve these outcomes and reduce the incidence of adverse effects in treated individuals. Further provided are method of co-administering the salts with other drugs to treat diseases of humans and animals.

Abstract: Solid pharmaceutical compositions with high drug loading are provided. A formulation useful for the solid pharmaceutical composition includes valbenazine, or a pharmaceutically acceptable salt thereof, silicified microcrystalline cellulose, isomalt, hydroxypropyl methylcellulose, partially pregelatinized maize starch, and magnesium stearate.

Abstract: Non-peptide MOR opioid receptor modulators are provided. The compounds exhibit predominantly central activity and are used to treat e.g. substance use disorders, and pain.

Abstract: Analogues of 6 ?/?-naltrexamine (NAQ) are provided. The analogues are selective, reversible antagonists of the mu opioid receptor (MOR) that exhibit good blood brain barrier penetration. The compounds are used in the treatment of opioid addiction and other diseases and conditions, including for the treatment of pain.

Abstract: Disclosed and described is a novel dose titration procedure for administering the opioid antagonist, nalmefene, to a patient diagnosed with post-traumatic stress disorder (PTSD).

Abstract: The invention provides stable liquid formulations containing naloxone, a pharmaceutically acceptable salt or a derivative thereof. The invention further provides methods for treating opioid overdose, opioid dependence, and congenital insensitivity to pain with anhidrosis by administering the liquid formulations of the present invention intranasally to a patient in need thereof. Further, the invention provides a method of treating opioid dependence, opioid overdose, and congenital insensitivity to pain with anhidrosis by administering intranasally the naloxone formulations of the present invention.

Abstract: In some aspects, pegylated aminoglycoside compounds are provided. In some embodiments, m-PEG-tobramycin compounds may be used to treat a biofilm infection or reduce or treat established biofilms.

Abstract: A liquid or semi-solid matrix or magma or paste which is non-newtonian, thixotropic and pseudoplastic and composed of one or more controlled release agent, and/or one or more clays such as bentonite and/or one or more fillers in a non aqueous vehicle, and optionally materials selected from disintegrants, humectants, surfactants and stabilizers. The composition and physicochemical properties makes it harder or prevents dose dumping of narcotic analgesics in the presence of alcohol and harder to abuse opiod agonists or narcotic analgesics and discourages drug abuse via crushing, milling or grinding the dosage form to powder or heating the dosage form to vapour and snorting or inhalation by the nasal route or dissolving to abuse via the parenteral route.

Abstract: Disclosed is a method for reducing or preventing fetal opioid dependence in a drug dependent or opioid tolerant pregnant subject. The method involves administering to the pregnant subject a composition comprising an opioid antagonist in an amount effective to reduce or prevent fetal opioid dependence, wherein the opioid antagonist a) is orally available or delivered systemically and reaches the circulation of the pregnant subject, b) is substantially excluded from the subject's brain by the blood brain barrier, and c) penetrates the placenta and enters the fetal brain. The method also includes administering the opioid antagonist to the neonate in increasing amounts to facilitate weaning the neonate from continued opioid maintenance.

Abstract: Compositions comprising hydrocodone benzoic acid enol ester to form novel prodrugs including hydrocodone benzoic acid enol ester salts, and various polymorphs. Also provided are processes for the preparation of hydrocodone benzoic acid enol ester salts, and various polymorphs.

Abstract: Provided are compounds, including those of Formula I; and pharmaceutically acceptable salts and solvates thereof. The compounds described herein relate to and/or have application(s) in (among others) the fields of drug discovery, pharmacotherapy, physiology, organic chemistry and polymer chemistry.

Abstract: The present disclosure relates to compositions, kits, uses, systems and methods related to naltrexone plus bupropion for treating an overweight or obese subject at increased risk of adverse cardiovascular outcomes. Preferably, the subject has had type-two diabetes for a period of less than 6 years or is a current smoker, optionally that does not have type-two diabetes.

Abstract: The invention relates to a composition comprising buprenorphine and a ? opioid receptor antagonist, wherein the composition is characterized by an Agonist Antagonist Activity Index (AAnAI) of between about 0.7 and about 2.2; wherein; AAnAI = [ C max ? ( BUP ) / EC 50 ] [ C max ? ( ANTAGONIST ) / IC 50 ] .

Abstract: Transdermal delivery devices for the delivery of cannabidiol (CBD) and related moieties are shown and described. In a reservoir-patch design, a microporous, hydrophilic membrane and a backing define a reservoir that houses a mixture of CBD, a polar liquid, and a gelling agent, along with other moieties that seem to be enhanced or bioavailability of increased by the same. The hydrophilic membrane is coated with an amine-compatible silicone skin adhesive. In a monolithic design, a release liner is coated with a mixture of CBD and a PIB or amine-compatible silicone skin adhesive laminated to the backing material. In using CBD as a pure compound or as one to combine with other moieties, the invention is able to control delivery better than the prior art. Construction of the transdermal patch of reservoir type is also taught, which enables things such as Vitamin B12 to become part of the complex deliverable by the inventions.

Abstract: An injectable pharmaceutical composition includes a solution of 3-acyl-buprenorphine, or a pharmaceutically acceptable salt thereof, in a biocompatible organic solvent, wherein the injectable pharmaceutical composition exhibits a steady release profile lasting over one week when injected into a patient. The acyl group is an alkylcarbonyl group, and an alkyl portion of the alkylcarbonyl group is a straight-chain, branched-chain, having 1-20 carbon atoms. The biocompatible organic solvent is N-methyl-2-pyrrolidone, ethyl acetate, ethanol, butanol, 2-butanol, isobutanol, ispropanol, glycerin, benzyl benzoate, dimethyl sulfoxide, N,N-dimethylacetamide, propylene glycol, dimethyl glycol, benzyl alcohol, or a combination of two or more thereof.

Abstract: An abuse resistant oral pharmaceutical composition, comprising: a barrier layer, comprising a first polymer; a diffusion layer, comprising a second polymer, substantially covering the barrier layer, wherein the diffusion layer is bonded to the barrier layer and comprises a drug that is substantially homogeneously distributed within the second polymer and diffuses from the diffusion layer within the gastrointestinal (GI) tract; and optionally an expansion layer comprising an expandable polymer, wherein the expansion layer is substantially covered by the barrier layer. Methods of making the same and methods of using the same are also provided.

Abstract: In certain embodiments the invention is directed to a process for preparing an oxycodone hydrochloride composition having less than 25 ppm of 14-hydroxycodeinone.

Abstract: A method for inducing a sustained immune response in humans or animal patient suffering from human immunodeficiency virus (HIV) acquired immune deficiency syndrome (AIDS, autoimmune disease, cancer, inflammation, and neurodegenerative diseases comprises daily administration to such patients a single oral tablet, rapidly dissolving film, capsule, liquid or cream dose of an Immediate release naltrexone composition comprising between about 0.01 to about 10 mg of naltrexone. In order to provide a benefit the naltrexone must be an Immediate release composition comprising between about 0.01 and about 10 mg of naltrexone.

Abstract: The present invention generally relates to a method of treating or preventing an endoplasmic reticulum stress disorder in subjects, such as a method of treating or preventing Wolfram syndrome.

Abstract: Abuse-resistant opioid compounds, drug delivery systems, pharmaceutical compositions comprising an opioid covalently bound to a chemical moiety are provided. Methods of delivering an active ingredient to a subject and methods of preventing opioid abuse are also provided.

Abstract: In certain embodiments the invention is directed to a process for preparing an oxycodone hydrochloride composition having less than 25 ppm of 14-hydroxycodeinone.

Abstract: The present disclosure relates generally to binder powders for use in powder material processing and processes for their preparation. The disclosure further relates to binder powders for use in making solid powder compact forms, solid powder compact forms containing said binder powders and methods for making solid powder compact forms.

Abstract: Methods and compositions are provided directed to decreasing visceral fat in subjects. Visceral fat is directly linked to cardiovascular and metabolic disease risk. The methods describe a calorie restricted diet of specific percentages of food elements to be consumed within a specific time period each day. Calorie restriction and nutrient percentages take into consideration average daily normal activity of subjects as well as baseline health metrics including estimated amount of visceral fat. Remarkable results are obtained since visceral fat is targeted for reduction, thereby markedly reducing the risk of cardiovascular and metabolic disease.

Abstract: A pharmaceutical paste composition comprising an active ingredient such as an addictive substance, a controlled release agent, and a pharmaceutically suitable aqueous or non-aqueous carrier. The composition may comprise one or more of a clay, or an oily, waxy, or fatty substance. The composition may be filled into a capsule or other dispensing device. The composition may reduce dose dumping of an active ingredient. Methods of making and using the composition are also described.

Abstract: The present invention provides (+)-morphinans comprising Toll-like receptor 9 (TLR9) antagonist activity, as well as methods for using the (+)-morphinans to treat pain. Also provided are pharmaceutical combination compositions comprising a (+)-morphinan and an opioid agonist/monoamine reuptake inhibitor, as well as methods for using the combination compositions to treat pain.

Abstract: The embodiments provide a percutaneous absorption composition for a basic medicament having improved transdermal absorbability. The percutaneous absorption composition comprises a sorbic acid and/or a metal sorbate as a percutaneous absorption promotor. The molar ration of the sorbic acid and/or the metal sorbate to the basic medicament is 0.5-2.5. The composition of the present disclosure may further comprise a basic component.

Abstract: The present invention provides a pharmaceutical composition comprising a selective serotonin reuptake inhibitor (SSRI) and a norepinephrine reuptake inhibitor (NRI), particularly, fluoxetine and reboxetine, for treating obesity. Surprisingly, the inventor of the present invention discovered that use of especially low doses of the active compounds, particularly, at most 6 mg/day of reboxetine and at most 20 mg/day of fluoxetine, wherein the reboxetinerfluoxetine ratio is from about 1:4 to about 1:6, induces an effective weight loss in obese patients. Advantageously, the combinations of the present invention include very low doses of the active ingredients, thereby decreasing possible drug-drug interactions and adverse drug reaction.

Abstract: An object of the present invention is to provide [(1R,5S,6S)-6-(aminomethyl)-3-ethylbicyclo[3.2.0]hept-3-en-6-yl]acetic acid monobenzenesulfonate as a stabilized pharmaceutical solid preparation, and also to provide a method for preparing the stabilized pharmaceutical solid preparation. The object can be attained by a pharmaceutical solid preparation comprising [(1R,5S,6S)-6-(aminomethyl)-3-ethylbicyclo[3.2.0]hept-3-en-6-yl]acetic acid monobenzenesulfonate which is a compound represented by the following formula (I) in combination with (i) one or two or more excipients, (ii) one or two or more disintegrants, and (iii) a specific antioxidant.

Abstract: A method of treating a pervasive development disorder in a subject includes administering to the subject an amount of an NMDAR antagonist effective to ameliorate biochemical and functional abnormalities in the subject associated with loss-of-function mutations of the gene encoding methyl-CpG binding protein 2 (MeCP2).

Abstract: 5-HT receptor agonists are useful in the treatment of a variety of diseases. Provided herein are methods of treating and/or reducing the occurrence of respiratory depression caused by an opioid in a human patient or patient population using a 5-HT receptor agonist, such as, for example, a 5-HT4 agonist (e.g., fenfluramine). Methods of stimulating one or more 5-HT4 receptors in the brain of a patient undergoing treatment with an opioid, wherein the patient is at risk of respiratory depression, by administering a 5-HT4 agonist (e.g., fenfluramine) to a subject in need thereof are provided. Pharmaceutical compositions for use in practicing the subject methods are also provided.

Abstract: The invention describes pharmaceutical compounds and compositions comprised of a ligand attached to opioids in a manner that substantially decreases or deters the potential for opioid abuse, addiction, illicit and illegal use, and overdose. When delivered at the proper dosage, the pharmaceutical composition provides therapeutic activity similar to that of the parent active agent.

Abstract: Some embodiments are directed to the use of creatine kinase or fragments thereof which induce analgesia, and also to the use of pharmaceutical compositions including the same, to relieve pain.

Abstract: An abuse deterrent pharmaceutical composition including a pharmaceutically active ingredient; an acid soluble ingredient; and a buffering ingredient; wherein the acid soluble ingredient and the buffering ingredient retard release of the active pharmaceutical ingredient when the composition is ingested in excess of an intended dosage.

Abstract: Immediate release, oral, pharmaceutical formulation comprising nalbuphine or a pharmaceutically acceptable salt thereof, and at least one hydrophilic granulation carrier, one hydrophilic binder and one lubricant.

Abstract: Methods of treating a heart condition include administering by inhalation an effective amount of at least one antiarrhythmic pharmaceutical agent to a patient in need thereof. Nebulized drug product and kits are also contemplated.

Abstract: The invention is directed to processes for the preparation of benzhydrocodone hydrochloride. More particularly, the invention is directed to processes for a one-pot synthesis of benzhydrocodone hydrochloride of improved yield and/or purity.

Abstract: The present disclosure relates to compositions, kits, uses, systems and methods for treating overweight and obesity using naltrexone plus bupropion, preferably in combination with a comprehensive web-based and/or telephone-based weight management program, and preferably in subjects at increased risk of adverse cardiovascular outcomes.

Abstract: Stable pharmaceutical compositions useful for administering methylnaltrexone are described, as are methods for making the same. Kits, including these pharmaceutical compositions, also are provided.

Abstract: There is provided a novel process for the preparation of a compound of formula (I), wherein R1 is as described in the description, by demethylation of a corresponding O-methyl derivative.

Abstract: Compositions comprising hydrocodone benzoic acid enol ester to form novel prodrugs including hydrocodone benzoic acid enol ester salts, and various polymorphs. Also provided are processes for the preparation of hydrocodone benzoic acid enol ester salts, and various polymorphs.

Abstract: The invention relates to a composition comprising buprenorphine and a ? opioid receptor antagonist, wherein the composition is characterized by an Agonist Antagonist Activity Index (AAnAI) of between about 0.7 and about 2.2; wherein; AAnAI = [ c ma ? ? x ? ( BUP ) / EC 50 ] [ c ma ? ? x ? ( ANTAGONIST ) / IC 50 ] .

Abstract: The present invention relates to a homogeneous, stable, and palatable pharmaceutical solution comprising baclofen, sorbitol and naltrexone.

Abstract: A pharmaceutical composition containing an anticancer compound, named isopicrinine, isolated from the plant Rhazya Stricta. The pharmaceutical composition may contain a salt, an analog, a derivative, and/or the prodrug of isopicrinine. A method of treating cancer with the pharmaceutical composition is disclosed. A method of extracting isopicrinine is also disclosed.

Abstract: The present disclosure provides acetate salts of buprenorphine, and its anhydrates, solvates, hydrates, and crystalline forms thereof, where the acetate salts of buprenorphine are essentially free of impurities. The disclosure further provides method of preparing the acetate salts, buprenorphine free base prepared from the acetate salts, other salts prepared from the free base, and pharmaceutical compositions thereof essentially free of impurities.

Abstract: The present invention provides a method for assessing bowel function in a patient, comprising providing the patient with a numeric analog scale for at least one parameter which is a measure of bowel function; causing the patient to indicate on the numeric analog scale the amount and/or intensity of the parameter being experienced; and observing the amount and/or intensity of the at least one parameter indicated on the numeric analog scale in order to assess bowel function.