This is the second published study evaluating this combination regimen for the treatment of MUD.2
The number of adults living with MUD has risen in recent years. In 2019, approximately 1 million adults in the
'Given the scale and severity of the methamphetamine epidemic in the
VIVITROL (naltrexone for extended-release injectable suspension) is not approved for the treatment of MUD. VIVITROL, developed by
About the ADAPT-2 Study
The '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 (defined as reported use on at least 18 of the 30 days prior to randomization) were randomized to combination therapy (XR-NTX, 380 mg IM every three weeks, plus bupropion XL, up to 450 mg/d) versus placebo in a two-stage study. Placebo non-responders from stage 1 (6 weeks) were re-randomized in stage 2 for another 6 weeks. The primary outcome was the proportion of 'responders,' defined as having at least three methamphetamine-negative urine samples out of four samples obtained during weeks 5-6 (for stage 1) or weeks 11-12 (for stage 2). Response rates were higher with XR-NTX plus bupropion than with placebo across both stages (overall weighted treatment effect of 11.1 percentage points; Wald z-test statistic = 4.53; p < 0.001; NNT =9), as well as in each stage [stage 1: (16.5% COMB vs. 3.4% PBO); stage 2: (11.4% COMB vs. 1.8% PBO)]. Secondary outcomes also favored treatment with XR-NTX plus bupropion XL as compared to placebo. Adverse events in the combination treatment group included gastrointestinal disorders, tremor, malaise, hyperhidrosis, and anorexia. Serious adverse events occurred in 8 of 223 participants (3.6%) who received XR-NTX plus bupropion in the study. Alkermes provided XR-NTX and matched placebo free of charge for use in this trial under a written agreement with NIDA.
About VIVITROL
VIVITROL (naltrexone for extended-release injectable suspension) is a once-monthly medication for the treatment of alcohol dependence and for the prevention of relapse to opioid dependence, following opioid detoxification. Treatment with VIVITROL should be part of a comprehensive management program that includes psychosocial support.
About Alkermes
Note Regarding Forward-Looking Statements
Certain statements set forth in this press release constitute 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the potential therapeutic and commercial value of XR-NTX plus bupropion as a combination treatment for MUD and the company's plans to engage with the FDA regarding potential options for VIVITROL relating to the ADAPT-2 data. You are cautioned that forward-looking statements are inherently uncertain. Actual results may differ materially from those expressed or implied in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others, whether the combination treatment of XR-NTX plus bupropion could be shown to be unsafe or ineffective; whether clinical results for this combination treatment will be predictive of results of future clinical studies or real-world results; the outcome of interactions with the FDA related to VIVITROL and the ADAPT-2 data and those risks and uncertainties described under the heading 'Risk Factors' in the company's Annual Report on Form 10-K for the year ended
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