Alkermes (ALKS) Announces Initiation of Phase 2b Clinical Study of ALKS 37 for the Treatment of Opioid-Induced Constipation
10/3/2011 9:49:19 AM
DUBLIN--(BUSINESS WIRE)--Alkermes plc (NASDAQ: ALKS) today announced the initiation of a phase 2b study of ALKS 37, an orally active, peripherally restricted opioid antagonist for the treatment of opioid-induced constipation (OIC). This multicenter, randomized, double-blind, placebo-controlled, fixed-dose study is designed to assess the safety and efficacy of daily administration of a 100 mg dose of ALKS 37 versus placebo for 12 weeks in approximately 80 patients with OIC. The results of this phase 2b study, along with those from the dose-ranging, four-week phase 2b study initiated earlier this year, are expected to be part of the End-of-Phase 2 submission package to the U.S. Food and Drug Administration (FDA).