Alkermes Announces Initiation of Multidose Phase 1 Clinical Study of ALKS 37 for the Treatment of Opioid-Induced Constipation
Press Release Source: Alkermes, Inc. On Wednesday March 17, 2010, 8:30 am
WALTHAM, Mass.--(BUSINESS WIRE)--Alkermes, Inc. (NASDAQ: ALKS) today announced the initiation of a multidose phase 1 clinical study of ALKS 37, an orally active, peripherally-restricted opioid antagonist with potential to block the effects of opioid agonists on gastrointestinal motility, commonly referred to as opioid-induced constipation (OIC). The randomized, double-blind, placebo-controlled, repeat-dose study will assess the safety, tolerability and pharmacokinetics of daily oral administration of two dose levels of ALKS 37 for a seven day period in approximately 24 healthy volunteers.
“We are pleased to be advancing ALKS 37 quickly through the clinic as it may have the potential to reverse this severe side effect of opioid administration with low systemic exposure and little to no central nervous system penetration,” said Dr. Elliot Ehrich, Chief Medical Officer of Alkermes. “ALKS 37, one of several proprietary product candidates in our growing clinical pipeline, is an excellent example of how the company is leveraging its unique understanding of opioid biology and pharmacology to develop medications with potential advantages over currently available therapies.”
This phase 1 multidose study follows completion of a previous single dose clinical study in healthy volunteers, which showed that ALKS 37 was generally well tolerated and demonstrated low systemic exposure across a wide range of doses. These results will support a phase 2 clinical study of ALKS 37, which will assess the safety, tolerability and efficacy of ALKS 37 in individuals with OIC. The phase 2 study is expected to begin in the first half of calendar 2010.
ALKS 37 Phase 1 Study Design
The phase 1 study of ALKS 37 is a randomized, double-blind, placebo-controlled, repeat-dose study designed to assess the safety, tolerability and pharmacokinetic effects of daily oral administration of ALKS 37 for a seven day period in approximately 24 healthy volunteers. Two dose levels of ALKS 37 will be tested in sequential cohorts.