Alkermes submits VIVITROL sNDA for opioid dependence
April 12, 2016
The submission of the sNDA follows 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 (ITT) analysis showed that patients treated once-monthly with VIVITROL demonstrated statistically significant higher rates of opioid-free urine screens, compared to patients treated with placebo (p<0.0002). Furthermore, the median patient taking VIVITROL had 90% opioid-free urine screens during the evaluation phase of the study and patients treated with VIVITROL demonstrated a significant reduction in opioid craving compared to patients treated with placebo as measured by a visual analog scale. VIVITROL was generally well tolerated in the study and no patients on VIVITROL discontinued the study due to adverse events. The most common adverse events experienced by patients receiving VIVITROL during the study were nasopharyngitis and insomnia.
SOURCE Alkermes, Inc.