Naltrexone: Phase III data

In the double-blind, Russian Phase III ALK21-013 trial in 250 patients, 90% of patients treated with 380 mg monthly intramuscular Vivitrol with counseling for 6 months had opioid-free urine screens, the primary endpoint, vs. 35% for placebo (p<0.0002). On secondary endpoints, Vivitrol led to a significantly higher rate of treatment completion (53% vs. 38%, p=0.017), a significantly lower incidence of opioid dependence per naloxone challenge (p<0.0001), and a significantly greater reduction in VAS-craving scores at week 8 (p=0.0048) and at week 24 (p=0.0029). Vivitrol was well tolerated with no drug-related severe adverse events. Data were presented at the American Psychiatric Association meeting in New Orleans. ...