Alkermes, Inc. (NASDAQ: ALKS) today announced the initiation of a phase 2 clinical study of ALKS 33, an investigational oral opioid modulator for the potential treatment of alcohol dependence and other central nervous system disorders. The study will assess the safety and efficacy of multiple doses of ALKS 33 in patients with alcohol dependence and is designed to further define the clinical profile of ALKS 33.
“The advancement of ALKS 33 in the clinic is an important step as we continue to build our proprietary pipeline, which is based on drugs that we believe have a high likelihood of clinical and commercial success,” stated Elliot Ehrich, M.D., Chief Medical Officer at Alkermes. “We expect to use the results from this phase 2 study to shape our plans for phase 3 clinical development.”
The phase 2 study is designed to assess the safety and efficacy of ALKS 33 in patients with alcohol dependence. In this multi-center, double-blind, placebo-controlled study, up to 440 patients will be randomized to receive daily oral administrations of one of three doses of ALKS 33 or placebo for a total of 12 weeks of treatment. The phase 2 study has an adaptive study design which enables an interim analysis after 40 percent of the patients are enrolled and on medication for eight weeks of treatment. The efficacy of ALKS 33 will be evaluated based on the percentage of patients who are abstinent from heavy drinking during the eight-week evaluation phase. Heavy drinking is defined as five or more drinks per day for men and four or more drinks per day for women. The pharmacokinetics and safety of ALKS 33 will also be evaluated.
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