Alkermes Initiates Phase 2 Clinical Study Of ALKS 33 For The Treatment Of Alcohol Dependence

Alkermes, Inc. (NASDAQ: ALKS) 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.


About ALKS 33


ALKS 33 is an oral opioid modulator that builds on Alkermes' unique understanding of biological pathways and opioid pharmacology as well as the company's clinical and commercial knowledge in the field of addiction. In October 2009, Alkermes presented topline data from two phase 1 clinical trials of ALKS 33. Data from the studies showed that ALKS 33 was generally well tolerated and demonstrated rapid oral absorption, high plasma concentrations and duration of action that supports once daily dosing. ALKS 33 was also shown to successfully block the effects of an opioid agonist for more than 24 hours following a single administration.


About Opioid Modulators


Opioid modulators can act as agonists, antagonists or partial agonists at opioid receptors throughout the body. Emerging biological research and new medicinal chemistry insights now allow for the development of novel opioid modulators with the potential to show enhanced activity at opioid receptor sites and could ultimately lead to improved therapeutic options.


Source

Alkermes, Inc.