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news.Alkermes' Vivitrol (naltrexone for extended-release injectable suspension) has received 12 to 1 votes from the US Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee stating that the drug should be approved for the treatment of opioiddependence.
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Alkermes said that the FDA will consider the Advisory Committee’s recommendation in its review of the supplemental new drug application (sNDA) that the company has submitted for Vivitrol.
Alkermes stated that the current prescription drug user fee act (PDUFA) date for Vivitrol, the target date for the FDA to complete its review of the Vivitrol sNDA, is 12 October 2010.
Alkermes CEO Richard Pops said that the Advisory Committee meeting outcome underscores the strength of the clinical data for Vivitrol and the need for new treatment options.
“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,” Pops said.