A supplemental New Drug Application (sNDA) for Alkermes’ VIVITROL (naltrexone for extended-release injectable suspension) for opioid dependence has been designated a priority review by the U.S. Food and Drug Administration (FDA).
If approved for opioid dependence, VIVITROL would be the first non-narcotic, non-addictive medication for the treatment of opioid dependence available in a once-monthly formulation.
“We are very encouraged by the FDA’s decision to grant priority review for VIVITROL for opioid dependence. The designation further supports the existence of a high unmet need for alternative therapies for patients with this chronic disease,” said Richard Pops, chief executive officer at Alkermes, Waltham, Mass.
The sNDA was submitted after completion of a six-month, multi-center, randomized Phase 3 clinical trial for VIVITROL for opioid dependence, which met its primary efficacy endpoint and all secondary efficacy endpoints. Data 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). 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.
Date: June 1, 2010
Source: Alkermes
Filed Under: Drug Discovery
