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Vivitrol

Generic name: naltrexone
Treatment for: Alcohol Use Disorder, Opioid Use Disorder

FDA Extends PDUFA Date for Vivitrex to December 30, 2005


Cephalon and Alkermes Continue to Anticipate Vivitrex Launch in First Half of 2006

FRAZER, Pa. & CAMBRIDGE, Mass., September 20, 2005 - Cephalon, Inc. (Nasdaq: CEPH) and Alkermes, Inc. (Nasdaq: ALKS) announced today that they have received notification from the United States Food and Drug Administration (FDA) that the agency has extended the action date to December 30, 2005 for its priority review of the New Drug Application (NDA) for Vivitrex (naltrexone long-acting injection) for the treatment of alcohol dependence. The original action date under the Prescription Drug User Fee Act (PDUFA) for the Vivitrex NDA was September 30, 2005. The companies continue to anticipate the launch of Vivitrex in the first half of 2006.

The extension is a result of the FDA classifying a recent response by Alkermes as a major amendment to the NDA, which permits the FDA to extend the action date by 90 days under PDUFA regulations.

"We will continue to work closely with the FDA to assist them in the completion of the review of the application in a timely manner," stated Richard Pops, CEO of Alkermes. "This extension does not affect our plans for the timing of the commercial launch of Vivitrex."

"We have made great progress in developing commercial launch plans for Vivitrex and remain on schedule for a product launch in the first half of 2006," said Frank Baldino, Jr., Ph.D., Chairman and CEO of Cephalon.

In June 2005, Cephalon and Alkermes entered into an agreement to develop and commercialize Vivitrex in the United States for the treatment of alcohol dependence.

Posted: September 2005

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