Alkermes, Inc. (NASDAQ: ALKS) today announced that the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee voted 12 to 1 that VIVITROL® (naltrexone for extended-release injectable suspension) should be approved for the treatment of opioid dependence.
"The Advisory Committee meeting outcome today underscores the strength of the clinical data for VIVITROL and the need for new treatment options," said Richard Pops, Chief Executive Officer of Alkermes. "We believe that, if approved, VIVITROL would offer a new path to recovery as the first non-addictive, once-monthly medication for patients with opioid dependence."
The Advisory Committee's recommendation, while not binding, will be considered by the FDA in its review of the supplemental New Drug Application (sNDA) that Alkermes has submitted for VIVITROL. The current Prescription Drug User Fee Act (PDUFA) date for VIVITROL is October 12, 2010; the PDUFA date is the target date for the FDA to complete its review of the VIVITROL sNDA.