Conditional Approval for Vivitrol Paves Way for Treatment of Alcoholism

The Food and Drug Administration has granted conditional approval to Vivitrol, a much-anticipated drug made by Alkermes Inc. that targets alcoholism. The medication, which is a once-a-month injection of naltrexone, has shown promise in reducing heavy drinking in patients undergoing counseling. While the FDA has requested additional scientific data and labeling negotiations, Alkermes CEO Richard Pops calls the conditional approval a "positive step." The company aims to make Vivitrol the first widespread drug to treat alcoholism, with analysts predicting it could bring in $300 million annually.

Key Takeaways:

• Vivitrol, a monthly injection of naltrexone, has been granted conditional approval by the FDA for the treatment of alcoholism.
• The medication has shown to reduce heavy drinking in patients undergoing counseling, with tests indicating a decrease in "heavy drinking days" per month.
• Alkermes has been working to build networks of therapists and doctors to increase access to prescribers and the drug.
• The company needs to provide additional scientific data to the FDA, including proof that the slow-release version of naltrexone works similarly to the pill version.
• The FDA label will need to be finalized, which may include a warning for possible liver damage, a concern that could impact prescriptions.
• Alkermes' CEO, Richard Pops, views the conditional approval as a positive step, but analysts like Ian Sanderson of SG Cowen & Co. consider the issues manageable.

Statistics:

• $300 million: The predicted annual revenue for Vivitrol, which could make Alkermes profitable for the first time in its 19-year history.
• 19 years: The length of time Alkermes has been operating.
• 12: The number of heavy drinking days per month that patients with non-injection naltrexone saw a decrease.
• 50/50: The estimated split of the market share between Vivitrol and its competitor, ReVia, a pill-based naltrexone.
• 2005: The year the conditional approval for Vivitrol was granted by the FDA.

Sources:

• "Alkermes' Vivitrol wins conditional approval from FDA". The Boston Globe, Dec 29, 2005.
• "Cephalon, Inc.".
• "Alkermes CEO, Richard Pops".
• "SG Cowen & Co."
• "ReVia, a pill-based naltrexone".