FDA grants priority review to Vivitrol for opioid dependence (En)
injection by Alkermes
May 25, 2010. Alkermes announced that the supplemental New Drug Application (sNDA) for Vivitrol (naltrexone for extended-release injectable suspension) for opioid dependence has been granted priority review by the FDA. Priority review status is granted to therapies that offer major advances in treatment or provide a treatment where no adequate therapy exists. This status accelerates the standard review time from ten to six months. 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. Additionally, 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 is an opioid antagonist administered once-monthly by intramuscular injection and is approved in the U.S. for the treatment of alcohol dependence.