Abstract: The invention provides an oral dosage form comprising (i) an amount of oxycodone and (ii) an amount of buprenorphine, wherein the weight ratio of the amount of buprenorphine to the amount of oxycodone is greater than 1:40 calculated with the amount of buprenorphine in the dosage form expressed as the equimolar amount of buprenorphine base (Mw=467.64 g/mol) in mg, and the amount of oxycodone in the dosage form expressed as the equimolar amount of oxycodone hydrochloride (Mw=351.82 g/mol) in mg. The invention also provides combinations of an opioid agonist and buprenorphine for use to treat pain, wherein the combination achieves a reduction of adverse pharmacodynamic responses (such as, respiratory depression), compared with a corresponding stand-alone opioid therapy. The invention also includes methods of treatment and dosage forms thereof comprising such combinations.

Abstract: A method of demethylizing an opioid to a nor-opioid is provided. The method comprises contacting an opioid with at least one enzyme. Contacting the opioid with the at least one enzyme converts the opioid to a nor-opioid. A method of converting a nor-opioid to a nal-opioid is provided. The method comprises contacting a nor-opioid with at least one enzyme. Contacting the nor-opioid with the at least one enzyme converts the nor-opioid to a nal-opioid.

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: The present disclosure is directed to a method of combatting opioid dependence in a subject experiencing a depressive episode. The method comprises treating the subject with an opioid agonist whilst managing their depression or depressive disorder using a step-wise interactive process, particularly where the process involves virtual cognitive behavioral therapy comprising a program for self-treatment. The self-treatment program could be embodied as a mobile medical application.

Abstract: A controlled release formulation comprising an opioid growth factor receptor (OGFR) antagonist and at least one pharmaceutically acceptable carrier has been developed, which is useful for treating cancer when locally administered at a disease site.

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 is directed to a method of combatting opioid dependence in a subject who is misusing alcohol or susceptible to alcohol misuse. The method comprises treating the subject with an opioid agonist whilst managing their alcohol consumption using a step-wise interactive process, particularly where the process involves virtual cognitive behavioral therapy comprising a program for self-treatment. The self-treatment program could be embodied as a mobile medical application.

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: This present invention relates to pharmaceutical composition comprising Deutetrabenazine. The invention also relates to the methods of preparation of the composition having improved stability and dissolution profile and used for the treatment of chorea associated with Huntington disease and tardive dyskinesia.

Abstract: A controlled release formulation comprising an opioid growth factor receptor (OGFR) antagonist and at least one pharmaceutically acceptable carrier has been developed, which is useful for treating cancer when locally administered at a disease site.

Abstract: A 12-hour anti-tussive modified release solid tablet or tablet-in-capsule is described which comprises a benzonatate-silicon dioxide adsorbate powder in a hydrophilic matrix to provide a 12-hour modified release profile to the benzonatate, wherein there is substantially no benzonatate release from the tablet or capsule in the buccal cavity and no more than about 1% release of the benzonatate within half an hour as determined in an in vitro dissolution assay.

Abstract: The present invention provides methods for treating and/or managing pain. The invention further provides methods for reducing or inhibiting opioid tolerance, reducing risk of opioid addiction or dependence, restoring opioid efficacy, and enhancing the therapeutic effect of an opioid. The invention further provides compositions for use in the methods of the invention.

Abstract: Drug products adapted for nasal delivery comprising formulations with epinephrine and devices comprising such formulations are provided. Methods of treating anaphylaxis with epinephrine products are also provided.

Abstract: According to the invention, there is provided a solid pharmaceutical composition formulation for nasal delivery of an opioid antagonist, comprising a pharmacologically-effective amount of an opioid antagonist and a pharmaceutically-acceptable carrier. The compositions are preferably in the form of a powder produced by spray-drying, which are subsequently loaded into single use nasal applicators. Preferred pharmaceutically-acceptable carriers in this regard include disaccharides (e.g. lactose or trehalose) and dextrins (e.g. cyclodextrins or maltodextrins), preferably spray-dried together in combination. Compositions may further comprise an alkyl saccharide, preferably a sucrose ester, such as sucrose monolaurate. The compositions and applicators may be employed in the treatment of opioid overdose in subjects.

Abstract: Disclosed in certain embodiments is a pharmaceutical formulation (e.g., parenteral formulation) comprising a therapeutically effective amount of nalmefene or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable adjuvant (e.g., parenterally acceptable adjuvant) that promotes the rate at which the nalmefene or salt thereof is more rapidly absorbed into the systemic circulation of a subject identified as in need thereof.

Abstract: Transdermal therapeutic system for the transdermal administration of a systemically active agent comprising a self-adhesive layer structure, comprising A) a backing layer, and B) a dried biphasic layer, the dried biphasic layer having a) an outer phase having a composition comprising 75% to 100% of a polymer or polymer mixture, and b) an inner phase having a composition comprising at least one active agent, wherein the inner phase forms dispersed deposits in the outer phase, and c) 0.1% to 3.5% of an interface mediator with a kinematic viscosity of from 10 cSt to 100 000 cSt at 25° C., and C) optionally an additional skin contact layer.

Abstract: Methods of using low dose naltrexone to treat chronic pain in a patient. The methods of using low dose naltrexone to treat chronic pain generally includes administering to the patient a first amount of naltrexone in an immediate-release agent and a second amount of naltrexone in a modified-release agent.

Abstract: Drug products adapted for nasal delivery comprising formulations with epinephrine and devices comprising such formulations are provided. Methods of treating anaphylaxis with epinephrine products are also provided.

Abstract: Drug products adapted for nasal delivery comprising formulations with epinephrine and devices comprising such formulations are provided. Methods of treating anaphylaxis with epinephrine products are also provided.

Abstract: A medicament comprising (I) brexpiprazole or a pharmaceutically acceptable salt thereof, and (II) nalmefene or a pharmaceutically acceptable salt thereof in combination, wherein brexpiprazole or a pharmaceutically acceptable salt thereof, and nalmefene or a pharmaceutically acceptable salt thereof are contained in a single preparation, or a pharmaceutical composition containing brexpiprazole or a pharmaceutically acceptable salt thereof and a pharmaceutical composition containing nalmefene or a pharmaceutically acceptable salt thereof are formulated for use in combination. The medicament is used for the prophylaxis or treatment of a substance-related disorder, preferably an alcohol-related disorder.

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: 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, the present disclosure provides compounds of the formula: wherein the variables are as defined herein. In some embodiments, these compounds may be used to reduce the pain of a patient. These compounds may be used in pain relief and show an improved pharmaceutical profile relative to other commonly used opiates and opioid derivatives.

Abstract: Described are immediate release oral dosage forms that contain abuse-deterrent features. In particular, the disclosed dosage forms provide deterrence of abuse by ingestion of multiple individual doses. In addition, the disclosed dosage forms provide protection from overdose in the event of accidental or intentional ingestion of multiple individual doses.

Abstract: Disclosed herein is a self-supporting, dissolvable, film containing dexmedetomidine or a pharmaceutically acceptable salt thereof. The film is administered orally to treat various conditions, particularly agitation, by transmucosal delivery of the active agent.

Abstract: The present invention encompasses improved morphian compositions and methods of use of the improved compositions for modulating neuropathic pain, opioid-induced glial activation, or a combination thereof beyond what is currently known in the art. The methods involve administering the compound of Formula I to a subject.

Abstract: Disclosed herein is a self-supporting, dissolvable, film containing dexmedetomidine or a pharmaceutically acceptable salt thereof. The film is administered orally to treat various conditions, particularly agitation, by transmucosal delivery of the active agent.

Abstract: The invention provides methods for treating chronic and acute pain. For example, the invention provides methods of treating neuropathic and inflammatory pain.

Abstract: Extended release, abuse deterrent dosage forms comprising crush-resistant controlled-release particles that provide abuse deterrent properties to the dosage forms. The crush-resistant controlled-release particles, which comprise plastic/elastic polymers and at least one active pharmaceutical ingredient (API) or a pharmaceutically acceptable salt thereof, are prepared by a hot melt extrusion process.

Abstract: Nasally targeted dry powder compositions and methods for their use in the treatment of exposure to organophosphate compounds including chemical warfare agents and pesticides. Compositions include anticholinergic agents and cholinesterase reactivator agents used for primary treatment and vasoactive agents and benzodiazepines used for secondary treatment of exposure, and combinations of these agents. Compositions incorporate excipients and enabling agents such as permeation enhancers, and optimal sizing of active pharmaceutical ingredient particle size to improve drug delivery across the nasal mucosa, stability, and resistance to heat degradation. Packaging and configuration of devices for dry powder nasal compositions enable their use by non-medical personnel in civilian mass casualty or battlefield environments.

Abstract: The present disclosure provides polymorphic forms of sodium benzoate with a X-ray diffraction pattern comprising characteristic peaks at a reflection angle 2? of approximately 5.9, 30.2, and 31.2 degrees; or a X-ray diffraction pattern comprising characteristic peaks at a reflection angle 2? of approximately 3.7, 5.9, and 26.6 degrees. The present disclosure provides polymorphic forms of sodium benzoate with a X-ray diffraction pattern comprising characteristic peaks at a reflection angle 2? of approximately 3.6, 7.5, 26.6, and 29.4 degrees. Also provided herein are methods of preparing the polymorphic forms of sodium benzoate and uses thereof in treating and/or reducing the risk for a neuropsychiatric disorder (e.g., schizophrenia, psychotic disorders, depressive disorders, or Alzheimer's disease).

Abstract: It has been found by the present inventors that agents that boost the expression of the opioid receptor kappa 1 (OPRK1) can enhance the cytotoxicity of chemotherapeutic agents in multiple cancer cell lines. Furthermore, the effect is dose dependent, where the greater the induced expression of OPRK1, the greater the cytotoxicity of the chemotherapeutic agent. The increase in overall cytotoxicity is independent of the cytotoxicity of the agent that increases the expression of OPRK1, which itself has no or minimal cytotoxic effect.

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: Disclosed are compositions for affecting weight loss comprising a first compound and a second compound, where the first compound is an opioid antagonist and the second compound causes increased agonism of a melanocortin 3 receptor (MC3-R) or a melanocortin 4 receptor (MC4-R) compared to normal physiological conditions. Also disclosed are methods of affecting weight loss, increasing energy expenditure, increasing satiety in an individual, or suppressing the appetite of an individual, comprising identifying an individual in need thereof and treating that individual to antagonize opioid receptor activity and to enhance ?-MSH activity.

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

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: The present invention related to novel morphinans, compositions comprising the novel morphinans, and their uses as agonists of the kappa opioid receptor.

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: Methylnaltrexone nasal formulations are disclosed which provide improved bioavailability over oral dosage forms and improved patient compliance over injectable dosage forms. Also disclosed are methods of making the nasal formulations and methods of using, specifically to treat the side effects of opioid drug use, such as constipation, and other indications.

Abstract: The present invention provides methods for treating and/or managing pain. The invention further provides methods for reducing or inhibiting opioid tolerance, reducing risk of opioid addiction or dependence, restoring opioid efficacy, and enhancing the therapeutic effect of an opioid. The invention further provides compositions for use in the methods of the invention.

Abstract: Drug products adapted for nasal delivery comprising formulations with epinephrine and devices comprising such formulations are provided. Methods of treating anaphylaxis with epinephrine products are also provided.

Abstract: Pharmaceutical compositions of one or more opioid antagonists or phosphodiesterase 5 (PDE5) inhibitors are disclosed.

Abstract: A solid preparation includes a 4,5-epoxymorphinan derivative or a pharmaceutically acceptable acid addition salt thereof, which is stable to light even without light shielding coating. The solid preparation includes an active ingredient composed of a 4,5-epoxymorphinan derivative or a pharmaceutically acceptable acid addition salt thereof, and one or more stabilizing agents selected from the group consisting of n-propyl gallate, sodium hydrogensulfite, dibutylhydroxytoluene, butylhydroxyanisole, tocopherol and D-isoascorbic acid, wherein the amount of the above active ingredient is 0.00001 to 0.01% by weight of the solid preparation, and the amount of the above stabilizing agent is 0.005 to 5% by weight of the solid preparation.

Abstract: The present invention provides compositions and methods and for increasing the bioavailability of therapeutic agents in a subject. The compositions include at least one alkyl glycoside and at least one therapeutic agent, wherein the alkylglycoside has an alkyl chain length from about 10 to about 16 carbon atoms.

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.