Monthly drug for alcoholism gets FDA approval

NEW YORK (Reuters) - U.S. health regulators on Thursday approved a new version of a drug to treat alcoholism that needs to be taken only once a month by injection.

Alkermes Inc. and Cephalon Inc. said the U.S. Food and Drug Administration approved their drug, Vivitrol, an injectable form of naltrexone administered monthly to help control cravings for alcohol.

The once-a-month treatment provides an alternative to existing oral medications that must be taken daily, freeing patients battling alcoholism from having to make a decision each day to take medicine.

The pill versions are sold generically and under the brand name ReVia by Barr Pharmaceuticals Inc. .

Alkermes and Cephalon expect Vivitrol to be available to doctors and patients in the United States by the end of June in the form of a single dose, 380-milligram intramuscular injection.

Cowen & Co. said Vivitrol sales could reach $300 million in 2010, assuming it gets 10 percent of patients seeking treatment. Other analysts have said peak sales could exceed $500 million.

The FDA in December granted Vivitrol conditional approval but said the companies had to provide more data before a final decision could be made, pushing final approval back by more than three months.

Under the terms of the agreement between the two companies, Alkermes receives a milestone payment of $110 million for the approval.

The drug was developed by Alkermes, which will manufacture Vivitrol, while Cephalon takes on marketing and sales responsibilities.

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