Alkermes, a biotechnology company, has initiated two new clinical trials of ALKS 33, an oral opioid modulator for the potential treatment of addiction and other nervous system disorders.
ALK33-004 is a Phase I, randomized, single-blind, placebo-controlled, single-dose study designed to test the ability of ALKS 33 to block the effects of an opioid agonist, remifentanil, a commercially available analgesic, in healthy, non-dependent, opioid-experienced subjects.
Approximately 24 healthy, non-dependent, opioid-experienced subjects will be randomized to receive a placebo dose as well as one of two dose levels of ALKS 33. The ability of ALKS 33 to block the effects of remifentanil will be measured by pupillometry assessments and subjective measures of opioid effects. The pharmacokinetics and safety of ALKS 33 will also be evaluated.
ALK33-003 is a Phase I randomized, double-blind, placebo-controlled, multi-dose study designed to assess the steady-state pharmacokinetics, safety and tolerability of ALKS 33 in healthy volunteers. Approximately 30 healthy subjects will be randomized to receive seven consecutive, daily oral doses of one of two dose levels of ALKS 33 or placebo.
The initiation of these studies follows the successful completion of a Phase I dose escalation study of ALKS 33 in healthy volunteers. Alkermes expects to report data from both ALK33-004 and ALK33-003 in the second half of calendar 2009.
Elliot Ehrich, chief medical officer of Alkermes, said: ALKS 33 is an excellent example of how Alkermes is leveraging its new insights about opioid receptor pathways to develop medications with unique advantages over currently available therapies. We expect to use the data from these additional Phase I studies to shape our plans for Phase II clinical development.