FDAnews
www.fdanews.com/articles/89744-alkermes-to-study-new-treatment-for-alcohol-addiction

ALKERMES TO STUDY NEW TREATMENT FOR ALCOHOL ADDICTION

March 7, 2007

Alkermes has completed patient enrollment in a Phase I/II clinical study of ALKS 29, the company's undisclosed oral compound for the treatment of alcohol dependence. The multicenter, randomized, double-blind, placebo-controlled trial is designed to assess the safety and efficacy of ALKS 29 in approximately 150 subjects with alcohol dependence. Alkermes expects to provide top-line results from this study in the first half of 2007.

"Addiction is an underserved disease area where a variety of treatments are needed that can improve outcomes for patients," Elliot Ehrich, chief medical officer of Alkermes, said. "ALKS 29 represents an important opportunity to bring forward a new medication for patients struggling with alcohol dependence."

Alcohol dependence is a serious and chronic disease that affects multiple regions of the brain, providing rationale for the use of medication with psychosocial support as part of an integrated treatment plan, according to the company. Psychosocial support, such as counseling or group therapy, is the traditional approach for treating alcohol dependence; however, experts in the field increasingly recommend and support a treatment approach that includes a combination of medication and psychosocial support.

The company's already approved Vivitrol (naltrexone for extended-release) is the first and only once-monthly injectable medication approved for the treatment of alcohol dependence and is marketed in the U.S. primarily by Cephalon.