Published on March 17, 2010 at 9:25 AM
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”
“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.
SOURCE Alkermes, Inc.
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Posted in: Drug Trial News | Medical Condition News
Tags: Alcohol Dependence, Biotechnology, Constipation, Diabetes, Nervous System, Opioids, Pharmacokinetics, Pharmacology, Placebo, Schizophrenia, Vivitrol