Alkermes submits Vivitrol MAA in UK and Germany

US biotechnology firm Alkermes has submitted a Marketing Authorization Application for Vivitrol (naltrexone for extended-release injectable suspension) to the UK Medicines and Healthcare Products Regulatory Agency (MHRA) and Germany's equivalent, the Bundesinstitut fur Arzneimittel und Medizinprodukte (BfArM). The company claims that Vivitrol is the first and only once-monthly treatment for alcohol dependence, was approved by the US Food and Drug Administration in April 2006.

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

The submission 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, more than 90% of whom were actively drinking at enrollment. The primary endpoint of the trial was the reduction in the event rate of heavy drinking days, these being defined as five or more drinks per day for men and four or more for women. The MAA also includes reference to oral naltrexone (marketed as Nalorex in the UK and Nemexin in Germany) and its approval in a number of European Union countries, including Austria, Denmark, France, Italy and Sweden, as a treatment for alcohol dependence.