Alkermes Submits sNDA for VIVITROL - Drug Discovery and Development

Alkermes, Inc. announced that it has submitted a supplemental New Drug Application (sNDA) for VIVITROL (naltrexone for extended-release injectable suspension) to the U.S. Food and Drug Administration (FDA) for approval as a treatment for opioid dependence. The company requested a priority review for its sNDA and if granted by the FDA, it would mean a six month review timeline. The sNDA is based on the positive results from a recent phase 3 study assessing the efficacy and safety of VIVITROL for opioid dependence. VIVITROL is an opioid antagonist administered once-monthly by intramuscular injection and is approved in the U.S. for the treatment of alcohol dependence. If approved by the FDA for the treatment of opioid dependence, VIVITROL would be the first and only non-narcotic, non-addictive drug agent available in a once-monthly formulation.

“Opioid dependence is a serious disease affecting millions of people yet there are limitations with currently available therapies,” stated Richard Pops, Chief Executive Officer of Alkermes. “As the first and only non-narcotic, non-addictive, once-monthly treatment option, VIVITROL for opioid dependence could significantly change the treatment paradigm. By seeking priority review, we hope to bring this much needed treatment to patients as soon as possible.”

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.

Date: April 13, 2010
Source: Alkermes, Inc.