Alkermes Submits NDA for Vivitrex to Treat Alcohol Dependence

Alkermes has submitted a new drug application (NDA) to the FDA for marketing approval of Vivitrex, an investigational drug in development for the treatment of alcohol dependence.

If approved, Vivitrex (naltrexone long-acting injection) would be the first medication available for the treatment of alcohol dependence in a formulation that is administered once-monthly by injection, the company said.

Vivitrex, an injectable, long-acting formulation of the currently approved drug naltrexone, was designed utilizing Alkermes' proprietary Medisorb drug-delivery technology. Using the Medisorb technology, naltrexone is encapsulated in microspheres made of a biodegradable polymer that dissolve slowly and release the drug at a controlled rate following intramuscular injection.