Alkermes Announces Results From Phase I/II ALKS 29 Study
Alkermes announced positive preliminary results from a clinical trial of ALKS 29 in alcohol-dependent patients.
Based on these results, Alkermes said it plans to move forward with its development program for oral product candidates to treat alcohol dependence.
In the study, ALKS 29 was generally well-tolerated and led to both a statistically significant increase in the number of days abstinent and a decrease in drinking compared with placebo when combined with psychosocial therapy, according to the company.
The Phase I/II multicenter, randomized, double-blind, placebo-controlled, eight-week study was designed to assess the efficacy and safety of ALKS 29 in approximately 150 alcohol-dependent patients. The study endpoints included the percent of days abstinent, percent of heavy drinking days and number of drinks per day. Heavy drinking is defined as five or more drinks per day for men and four or more drinks per day for women, the company said.