Naltrexone/bupropion: Contrave(R); naltrexone SR/bupropion SR.
In March 2010, Orexigen(R) Therapeutics submitted a new drug application (NDA) for approval of naltrexone sustained release (SR)/bupropion SR (Contrave(R)) for the treatment of obesity in the US. The tablet contains naltrexone SR 32 mg and bupropion SR 360 mg. The drug has been tested in four randomized, double-blind, placebo-controlled, phase III trials and the co-primary endpoints were met in each case. This review discusses the key development milestones and clinical trial program to date.
D000818:Animals; D019440:Anti-Obesity Agents / Q000494:pharmacology / Q000627:therapeutic use*; D016642:Bupropion / Q000008:administration & dosage* / Q000494:pharmacology / Q000627:therapeutic use; D017322:Clinical Trials, Phase II as Topic; D017326:Clinical Trials, Phase III as Topic; D003692:Delayed-Action Preparations / Q000494:pharmacology / Q000627:therapeutic use*; D004338:Drug Combinations; D004353:Drug Evaluation, Preclinical; D015507:Drugs, Investigational / Q000494:pharmacology / Q000627:therapeutic use*; D006801:Humans; D009271:Naltrexone / Q000008:administration & dosage* / Q000494:pharmacology / Q000627:therapeutic use; D009765:Obesity / Q000188:drug therapy*
D019440:Anti-Obesity Agents; D003692:Delayed-Action Preparations; D004338:Drug Combinations; D015507:Drugs, Investigational; C000591595:bupropion hydrochloride, naltrexone hydrochoride drug combination; D016642:Bupropion; D009271:Naltrexone