Alkermes has completed patient enrollment for the registration study of Vivitrol for the treatment of opioid dependence, a chronic brain disease.
The Phase III randomized, multi-center study is designed to assess the efficacy and safety of Vivitrol compared to placebo treatment in opioid dependent subjects who have been recently detoxified and abstinent from opioids for a minimum of seven days prior to treatment initiation. More than 250 subjects have been randomized to receive once-monthly intramuscular injections of either Vivitrol or placebo in combination with counseling for six months.
The primary efficacy endpoint is the response profile based on the rate of positive urine drug test results. All participants who complete the randomized portion of the study will be eligible to continue in an open-label phase and receive Vivitrol once-monthly in combination with counseling for an additional seven months.
The objective of the extension phase of the study is to assess the long-term durability of effect, health economics and quality of life outcomes with once-monthly Vivitrol injections. The data from this study will form the basis of a supplemental new drug application (sNDA) to the FDA for Vivitrol for the treatment of opioid dependence.
Vivitrol is a once-monthly, intramuscular injection approved in the US and Russia for the treatment of alcohol dependence and is not currently approved for the treatment of opioid dependence. Alkermes expects to report topline results from this registration study in late calendar 2009 and anticipates an sNDA submission in calendar 2010.
Elliot Ehrich, chief medical officer of Alkermes, said: The completion of patient enrollment in this registration study of Vivitrol for the treatment of opioid dependence is an important milestone, as there are few approved medications available for these patients and no approved long-acting antagonist therapies. Beyond the registration study, we are expanding the Vivitrol development program with a new study of Vivitrol in healthcare professionals.