Alkermes, Cephalon get FDA OK for alcoholism drug
NEW YORK, Apr 13 (Reuters) Alkermes Inc. and Cephalon Inc. said on Thursday the U S Food and Drug Administration approved their alcoholism drug, Vivitrol, sending shares of both companies higher.
The drug is an injectable form of naltrexone administered monthly to help control cravings for alcohol.
The companies 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.
The FDA in December granted Vivitrol conditional approval but said the companies had to provide more data before a final decision could be made.
Under the terms of the agreement between the two companies, Alkermes receives a milestone payment of 0 million for the approval.
The drug was developed by Alkermes, which will manufacture Vivitrol, while Cephalon takes on marketing and sales responsibilities.
The drug is expected to be prescribed in conjunction with therapy for patients who are able to abstain from drinking in an outpatient setting and are not actively drinking when initiating treatment, the companies said.
The once-a-month treatment frees patients battling alcoholism from having to make a decision to take medicine on a daily basis.
Shares of Alkermes rose 89 cents, or 4.2 percent, to close at .96 on Nasdaq. They continued to climb after hours, trading for .24 on Inet electronic brokerage.
Cephalon shares closed up 48 cents at .20 on Nasdaq, but slipped to .15 in extended trading on Inet.
REUTERS PG BST0217