Alkermes: FDA Panel Will Review Vivitrol In Sept.
From Associated Press (June 17, 2010)
WALTHAM, Mass. -- Drug developer Alkermes Inc. said Thursday a Food and Drug Administration committee will meet to review a possible new approved use for its addiction drug Vivitrol in September.
On Sept. 16, the agency’s Psychopharmacologic Drugs Advisory Committee will review Vivitrol as a treatment for dependency on opioids, or drugs like heroin that are based on or similar to opium. Vivitrol is a once-per-month injection that is currently approved for treating alcohol addiction.
Alkermes requested the new approval in April, and the FDA is scheduled to make a decision by Oct. 12. The FDA is not required to follow the advice of its panels, but a favorable panel review would improve the odds that the FDA will grant the new approval, and a negative review would hurt the drug’s chances.
In aftermarket trading, Alkermes shares slipped 2 cents to $11.54. The stock lost a penny to $11.56 during the day.
Posted: June 2010