Article Date: 08 Jul 2011 - 8:00 PDT
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Alkermes, Inc. (NASDAQ: ALKS) today announced topline results from a phase 2 clinical study of ALKS 33 in the treatment of binge eating disorder. This randomized, double-blind, placebo-controlled, 12-week study was designed to assess the safety and efficacy of daily oral administration of ALKS 33 or placebo in 68 patients with binge eating disorder. While ALKS 33 demonstrated a significant reduction from baseline in the efficacy endpoint of self-reported weekly binge eating episodes, the reduction was not significantly different from that observed with placebo. Based on these results, the company has determined that future studies in the binge eating indication are less attractive than other potential alternatives and will not pursue further development of ALKS 33 in this area.
ALKS 33 remains in development for other central nervous system indications based on the compound's favorable characteristics of once-daily dosing, limited hepatic metabolism and durable pharmacologic activity in modulating brain opioid receptors. ALKS 33 is currently being evaluated as a potential treatment for alcohol dependence and, in combination with buprenorphine as ALKS 5461, for cocaine addiction and treatment-resistant depression (TRD).
"The advantage of our R&D approach is that we are able to quickly determine a candidate's therapeutic viability for a particular indication in order to focus our resources on clinical candidates that show the most promise," said Dr. Elliot Ehrich, Chief Medical Officer of Alkermes. "Based on the results of this study, we will focus our future clinical development efforts on the other ALKS 33 development programs, including ALKS 5461 for TRD and cocaine addiction and ALKS 33 for alcohol dependence, as well as our other promising pipeline candidates including ALKS 9070 for schizophrenia and ALKS 37 for opioid-induced constipation."
Study Details
The phase 2, randomized, double-blind, placebo-controlled, 12-week study was designed to assess the safety and efficacy of daily oral administration of ALKS 33 in 68 patients with binge eating disorder. Binge eating episodes were defined using DSM-IV-TR1 criteria and assessed based on interviews and review of take-home diaries at weekly physician visits.
1. Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision
Source:
Alkermes, Inc.
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