The clinical 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, 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.
Approximately 200 subjects will be 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.
Elliot Ehrich, chief medical officer of Alkermes, said: “If approved, Vivitrol would be the first and only non-narcotic, non-addictive, long-acting medication for the treatment of opioid dependence.”