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).
"We believe ALKS 37 has the potential to normalize bowel function in patients being treated with opioids for chronic pain, without affecting their analgesic effects, and we are excited to initiate this phase 2b study of ALKS 37 for OIC," said Elliot Ehrich, M.D., Chief Medical Officer of Alkermes. "OIC is a significant and growing clinical condition because of widespread use of opioids to treat chronic pain, and we look forward to seeing the results of both phase 2b studies of ALKS 37 in mid-2012."
In February 2011, Alkermes announced data from its first phase 2 double-blind, randomized, placebo-controlled clinical study of ALKS 37, which showed that it significantly improved gastrointestinal motility and increased the frequency of bowel movements in patients with OIC, while simultaneously preserving the analgesic effects of opioid treatment. The study also demonstrated that ALKS 37 was generally well tolerated with limited systemic exposure and bioavailability. In July 2011, Alkermes announced the initiation of a dose-ranging phase 2b study of ALKS 37 for the treatment of OIC. The multicenter, randomized, double-blind, placebo-controlled, repeat-dose study is designed to assess the safety, tolerability, pharmacokinetic profile and efficacy of ALKS 37 in approximately 150 patients.
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