Alkermes Pursues Country-by-Country Approval of Vivitrol

Alkermes announced that the company has submitted a marketing authorization application for Vivitrol to regulatory authorities in the UK and Germany.

Vivitrol (naltrexone for extended-release injectable suspension), the first and only once-monthly treatment for alcohol dependence, was approved by the FDA in April 2006.

The marketing authorization application (MAA) for Vivitrol was submitted under a decentralized procedure, in which the UK will act as the reference member state and Germany will act as the concerned member state. If successful, a filing under the decentralized procedure would result in a simultaneous approval of Vivitrol as a treatment for alcohol dependence in both countries.

"This MAA submission is a key milestone for Alkermes and reflects our targeted approach to commercialize Vivitrol in Europe on a country-by-country basis," David Broecker, president and CEO of Alkermes, said.

The application is based on the safety and efficacy data from a six-month, multicenter, double-blind, randomized, placebo-controlled, Phase III study in 624 alcohol-dependent patients. The primary endpoint of the study was the reduction in the event rate of heavy drinking days. The MAA also includes reference to oral naltrexone and its approval in a number of European Union member states, including Austria, Denmark, France, Italy and Sweden, as a treatment for alcohol dependence.