Alkermes said that it expects the FDA to classify the response as a “class 1” resubmission, under which the FDA will seek to complete its review within 60 days.
Vivitrol is under review as a once-a-month injection for the treatment of alcohol dependence in combination with a treatment program that includes psychosocial support. The application for the drug was first submitted in March 2005.
In June 2005, Alkermes and Cephalon entered into a collaboration agreement to develop and commercialize the drug in the US.
Alkermes develops products based on sophisticated drug delivery technologies to enhance therapeutic outcomes in major diseases. The company’s lead commercial product, Risperdal Consta, is the first and only long-acting atypical antipsychotic medication approved for use in schizophrenia, and is marketed worldwide by Janssen-Cilag, a wholly-owned division of Johnson & Johnson.