Alkermes submits NDA for alcohol dependence treatment

Alkermes has submitted a New Drug Application (NDA) to the FDA for marketing approval of Vivitrex (naltrexone long-acting injection), an investigational drug in development for the treatment of alcohol dependence.

If approved, Vivitrex would be the first medication available for the treatment of alcohol dependence in a formulation that is administered once-monthly by injection.

'This NDA submission is a major milestone in our Vivitrex development program, which comprises a comprehensive US clinical trials program, manufacturing infrastructure and extensive regulatory and research expertise,' commented Richard Pops, chief executive officer of Alkermes. 'I'd like to take this opportunity to congratulate the many employees at Alkermes who built and integrated these capabilities and made this regulatory filing possible.'

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 drug at a controlled rate following intramuscular injection.

In the US, approximately 18m people are dependent on or abuse alcohol¹ and 2.3m adults seek treatment each year². Taking prescribed medication, an important determinant in therapeutic outcomes³, is particularly challenging for patients with addictive disorders such as alcohol dependence⁴. Alcohol is causally related to more than 60 medical conditions, including heart disease, liver disease, infectious disease, and cancer^5,6, and contributes to more than 100,000 deaths in the U.S. each year⁷. In addition, alcohol dependence accounts for approximately $134bn in lost earnings annually⁸.