Alkermes Requests Speedy Review of Drug for Opioid Dependence

Alkermes has asked the FDA to give its sNDA for Vivitrol for treatment of opioid dependence priority review, which would mean a six-month review period rather than the standard 10 months. Vivitrol (naltrexone) suspension for extended-release intramuscular injection would be the first non-narcotic, nonaddictive, once-monthly drug treatment for opioid addiction if approved, the company said.
Washington Drug Letter