FDA Advisory Committee recommends approval of Alkermes' VIVITROL for opioid dependence

NewsGuard 100/100 Score

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.


The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
Post a new comment

While we only use edited and approved content for Azthena answers, it may on occasions provide incorrect responses. Please confirm any data provided with the related suppliers or authors. We do not provide medical advice, if you search for medical information you must always consult a medical professional before acting on any information provided.

Your questions, but not your email details will be shared with OpenAI and retained for 30 days in accordance with their privacy principles.

Please do not ask questions that use sensitive or confidential information.

Read the full Terms & Conditions.

You might also like...
Renaissance of "food as medicine" in modern clinical trials