ARTICLE | Clinical News

ALKS 33: Preliminary Phase II data

December 13, 2010 8:00 AM UTC

Preliminary data from a double-blind, U.S. Phase II trial in 400 alcohol dependent patients showed that once-daily 1, 2.5, and 10 mg oral ALKS 33 for 12 weeks missed the primary endpoint of significantly increasing the proportion of patients who were completely abstinent from heavy drinking during the evaluation phase of the trial from weeks 5-12 vs. placebo (13.5%, 17% and 15.8%, respectively, vs. 13.9%). Alkermes said the primary endpoint, which has not been previously used in any clinical trial, was not sensitive enough to capture the difference in drinking behavior observed in the study. ...