FDA Approves Naltrexone for Extended-Release Injectable Suspension for the Treatment of Alcohol Dependence

The US FDA has approved naltrexone for extended-release injectable suspension (Vivitrol, Alkermes/Cephalon) for the treatment of alcohol dependence. The recommended starting dose of naltrexone for extended-release injectable suspension is 380 mg intramuscular every 4 weeks or once a month on alternating buttocks. The medication is administered via intramuscular injection by a health care professional and is not to be administered intravenously. Patients should not be actively drinking during the initial administration of the medication.

The approval was based on data from a 24-week, placebo-controlled, multi-center, double-blind, randomized trial of alcohol dependent outpatients. Patients receiving naltrexone for extended-release injectable suspension 380 mg were found to have a greater reduction in days of heavy drinking than those patients in the placebo group.

Adverse events found in preclinical trials of naltrexone for extended-release injectable suspension included injection site reactions, nausea, pregnancy, headache, and suicide-related events. For more information, please consult the medication’s full prescribing information at http://vivitrol.com/.