FDA grants priority review for Alkermes' VIVITROL sNDA for opioid dependence

May 25 2010

Alkermes, Inc. (NASDAQ: ALKS) today announced that the supplemental New Drug Application (sNDA) for 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). The designation is assigned to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists and accelerates the FDA's target review timeline from ten to six months. The FDA has issued an action date for the sNDA of October 12, 2010 under the Prescription Drug User Fee Act (PDUFA). If approved for opioid dependence, VIVITROL would be the first and only 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”

"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. "Developing VIVITROL for this indication reinforces our commitment to patients and treatment providers in this field; we remain dedicated to bringing future addiction treatments to this population."

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 from the intent-to-treat 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.