Alkermes, Inc. (NASDAQ: ALKS) today announced positive topline results from a phase 1 clinical study of an investigational combination of ALKS 33, one of Alkermes' proprietary candidates, and buprenorphine, an existing medication for the treatment of opioid addiction, for the treatment of cocaine addiction. Data from the study showed that the combination therapy was generally well tolerated and sublingual administration of ALKS 33 effectively blocked the agonist effects of buprenorphine. Based on these positive results, Alkermes expects to initiate a phase 2a study of the combination therapy in the first half of calendar year 2011. The phase 2a study will be funded through a grant from the National Institute on Drug Abuse (NIDA). NIDA has granted Alkermes up to $2.4 million to accelerate the clinical development of the ALKS 33 and buprenorphine combination therapy. Currently, there are no medications approved for the treatment of cocaine addiction.
"We are excited to collaborate with NIDA and leverage our ongoing clinical and preclinical work with ALKS 33 to explore a potential new non-addictive therapy for cocaine addiction," said Dr. Elliot Ehrich, Chief Medical Officer of Alkermes. "We look forward to continuing the recent momentum in our research and development efforts by initiating a phase 2a clinical trial to generate further data, as we advance the ALKS 33 and buprenorphine combination therapy as part of Alkermes' growing pipeline of proprietary product candidates."
Buprenorphine is widely used for the treatment of opioid addiction, despite its own potential for abuse. Combining ALKS 33, an opioid modulator, with buprenorphine, a partial opioid agonist, may block the agonist effects of buprenorphine thereby reducing the potential for the development of opioid dependence while still maintaining effective therapeutic action. Furthermore, the unique pharmacologic properties and low dose of ALKS 33 required to effectively block mu opioid receptors may allow for a co-formulation with buprenorphine as a single sublingual tablet.
The phase 1 study was a randomized, double-blind, multi-dose, placebo-controlled clinical trial that assessed the safety, tolerability and pharmacodynamic effects of the combination of ALKS 33 and buprenorphine when administered alone and in combination to 12 opioid-experienced users. Sublingual administration of ALKS 33 effectively blocked the objective and subjective measures of opioid agonism of co-administered buprenorphine in a dose-related manner. The combination therapy was generally well tolerated in the phase 1 study and Alkermes plans to present the full results of the phase 1 study at a future medical meeting.
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