Alkermes, Inc. (NASDAQ: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has notified the company of the tentative scheduling of a Psychopharmacologic Drugs Advisory Committee meeting on September 16, 2010, for the review of the company's supplemental New Drug Application (sNDA) for VIVITROL® (naltrexone for extended-release injectable suspension) for opioid dependence. Notification of this potential advisory committee meeting follows a designation in May 2010 by the FDA of priority review of the VIVITROL sNDA, a designation that accelerates the FDA's target review timeline from ten to six months for drugs that offer major advances in treatment or provide a treatment where no adequate therapy exists. With priority review, the Prescription Drug User Fee Act (PDUFA) date for the FDA's decision regarding approval of the VIVITROL sNDA for opioid dependence is October 12, 2010.
"The upcoming FDA advisory committee meeting represents progress toward our goal of obtaining approval of VIVITROL for patients with opioid dependence, building on the recent priority review designation by the FDA and our compelling phase 3 pivotal data showing the efficacy of VIVITROL for opioid dependence. We are pleased that the FDA has moved expeditiously to schedule a panel prior to the PDUFA date," stated Richard Pops, Chief Executive Officer of Alkermes. "We are confident in our sNDA submission and look forward to discussing the efficacy and safety data for VIVITROL for opioid dependence with the members of the panel and the FDA review team. If approved, VIVITROL could change the treatment paradigm as the first and only non-narcotic, non-addictive, once-monthly medication for the treatment of opioid dependence."
Alkermes submitted the sNDA for VIVITROL for opioid dependence in April 2010. Confirmation and details of the FDA advisory committee meeting for VIVITROL are expected to be published in the Federal Register about six to eight weeks prior to the scheduled meeting date. The Federal Register notice will be available at the following website: http://www.accessdata.fda.gov/scripts/oc/ohrms/index.cfm.
The sNDA is based on statistically significant results from a recent phase 3 study assessing the efficacy and safety of VIVITROL for opioid dependence. VIVITROL is an opioid antagonist administered once-monthly by intramuscular injection and is approved in the U.S. for the treatment of alcohol dependence.