ARTICLE | Regulation

Comparative Addiction

Russian trial satisfies FDA panel on Alkermes' Vivitrol for opioid dependence

September 20, 2010 7:00 AM UTC

Satisfied that positive results from a single Russian pivotal trial were applicable to addicts in the U.S., an FDA panel voted to recommend a label expansion for Alkermes Inc.'s Vivitrol naltrexone to include prevention of relapse in patients with opioid dependence. The biotech supported the Phase III trial with bridging studies plus years of postmarketing experience in alcohol dependence.

Vivitrol is a once-monthly injectable formulation of the mu opioid receptor antagonist naltrexone that uses Alkermes' Medisorb technology. The product has been available in the U.S. to treat alcohol dependence since 2006...