"Opioid dependence is a growing disease and we believe that VIVITROL offers physicians and their patients a whole new approach, as the only long-acting, non-addictive treatment for opioid dependence," stated Richard Pops, Chief Executive Officer of Alkermes. "We look forward to helping to improve the lives of patients with this chronic and debilitating condition."

The FDA approval of VIVITROL for the prevention of relapse to opioid dependence was based on data from a six-month, multi-center, randomized phase 3 study which met its primary efficacy endpoint and all secondary efficacy endpoints. Data from the intent-to-treat analysis showed that patients treated once a month with VIVITROL demonstrated statistically significant higher rates of opioid-free urine screens compared to patients treated with placebo (p<0.0002). VIVITROL was generally well tolerated in the study. The most common clinical adverse events experienced by patients receiving VIVITROL during the study were hepatic enzyme elevations, nasopharyngitis and insomnia.

Source: Alkermes, Inc.