Alkermes Announces Positive Results From Two Clinical Trials Of ALKS 33

Main Category: Alcohol / Addiction / Illegal Drugs
Also Included In: Clinical Trials / Drug Trials
Article Date: 15 Oct 2009 - 1:00 PDT

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Alkermes, Inc. (NASDAQ: ALKS) announced positive topline data from two clinical trials of ALKS 33, an investigational oral opioid modulator for the treatment of addiction and other central nervous system disorders. Data from the studies, ALK33-003 and ALK33-004, showed that ALKS 33 was generally well tolerated and successfully blocked the effects of an opioid, with a duration of action that supports once daily dosing. Based on these results, Alkermes expects to initiate a phase 2 study of ALKS 33 by the end of calendar 2009.

"The data for ALKS 33 demonstrate our ability to develop new chemical entities based on our unique understanding of biological pathways and opioid pharmacology and sets the stage for the next phase of growth for our pipeline," said Elliot Ehrich, M.D., Chief Medical Officer at Alkermes. "We look forward to moving ALKS 33 into phase 2 development."

Trial Designs and Results

ALK33-003 was a phase 1 randomized, double-blind, placebo-controlled, multi-dose study designed to assess the steady-state pharmacokinetics, safety and tolerability of ALKS 33. Thirty healthy subjects were randomized to receive seven consecutive, daily oral doses of one of two dose levels of ALKS 33 or placebo. In the study, ALKS 33 demonstrated rapid oral absorption and sustained pharmacologically active plasma levels that support once daily dosing.

ALK33-004 was a phase 1, randomized, single-blind, placebo-controlled, single-dose study designed to test the ability of ALKS 33 to block the subjective and objective effects of a potent opioid agonist, remifentanil, a commercially available analgesic. Twenty-four healthy, non-dependent, opioid-experienced subjects were randomized to receive a placebo dose as well as one of two dose levels of ALKS 33, the same doses investigated in ALK33-003. Data showed that the onset of action of ALKS 33 was rapid and observed as early as 15 minutes following oral administration. A full blockade of the opioid agonist was observed and sustained for more than 24 hours following a single administration of ALKS 33. ALKS 33 was generally well tolerated in both studies.

About Opioid Receptor Pathways

Opioid receptor pathways have biological activity throughout the body including the brain, gastrointestinal system, immune system and cardiovascular system. Consequently, opioid receptor pathways play a key role in a broad range of nervous system disorders such as pain, addiction, psychiatric disorders, gastrointestinal disorders and immune disorders. 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