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.

SOURCE Alkermes, Inc.