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NIDA-Funded Study Evaluating Extended-Release Injectable Naltrexone Plus Bupropion for the Treatment of Methamphetamine Use Disorder Published in New England Journal of Medicine
DUBLIN, Jan. 14, 2021 /PRNewswire/ -- Results from a National Institute on Drug Abuse (NIDA)-funded study evaluating the efficacy and safety of naltrexone for
About this update from Alkermes Plc
[{"type":"text","content":"DUBLIN, Jan. 14, 2021 /PRNewswire/ -- Results from a National Institute on Drug Abuse (NIDA)-funded study evaluating the efficacy and safety of naltrexone for extended-release injectable suspension (XR-NTX) administered once every three weeks plus oral extended-release bupropion administered daily as a combination treatment for adults with moderate or severe methamphetamine use disorder (MUD) were published today by Dr. Madhukar H. Trivedi et al. in the New England Journal of Medicine (NEJM).1 This is the second published study evaluating this combination regimen for the treatment of MUD.2 \nThe number of adults living with MUD has risen in recent years. In 2019, approximately 1 million adults in the U.S. reported having a methamphetamine use disorder—an increase of more than 50 percent since 2016.3 Currently, there are no FDA-approved medicines for the treatment of MUD. \n\"Given the scale and severity of the methamphetamine epidemic in the U.S., we applaud the clinical community's efforts and commitment to advancing research focused on treatment options for this critically underserved patient population,\" said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President of Research & Development at Alkermes. \"We're encouraged by the publication of this NIDA-funded study in the New England Journal of Medicine, and plan to engage with the FDA to better understand what options may exist for VIVITROL with regards to these data.\"\nVIVITROL® (naltrexone for extended-release injectable suspension) is not approved for the treatment of MUD. VIVITROL, developed by Alkermes (Nasdaq: ALKS), was approved by the U.S. Food and Drug Administration (FDA) for the treatment of alcohol dependence in 2006 and for the prevention of relapse to opioid dependence, following opioid detoxification, in 2010. VIVITROL is to be administered once every four weeks as part of a comprehensive management program that includes psychosocial support.\nAbout the ADAPT-2 StudyThe \"Accelerated Development of Additive Pharmacotherapy Treatment (ADAPT-2) for Methamphetamine Use Disorder\" study was a multi-site, double-blind, 12-week trial to evaluate the efficacy and safety of XR-NTX (380 mg every three weeks) plus oral extended-release bupropion (450 mg/day) in adults with moderate or severe MUD. Participants (N=403) with moderate or severe MUD (defi...