GSK, Adolor Suspend Studies of OBD Drug

GlaxoSmithKline (GSK) and Adolor announced data from Study 014 and provided an update on the clinical development program for alvimopan, also known as Entereg and Entrareg.

Study 014, a Phase III, double-blind, placebo-controlled, 12-month study, was designed to evaluate the long-term safety and tolerability of alvimopan 0.5 mg twice daily in patients taking opioids for chronic noncancer pain and experiencing opioid-induced bowel dysfunction (OBD). A total of 805 patients were enrolled into the study and randomized 2-1.

Consistent with findings from previous studies, the most common adverse events observed in Study 014 were those affecting the gastrointestinal (GI) tract, including abdominal pain and diarrhea. The incidence of GI adverse events observed was similar between patients treated with alvimopan and placebo.

While the proportion of patients experiencing serious adverse events was similar between those treated with alvimopan and placebo, a numerical imbalance was observed in the number of cardiovascular and neoplasm cases categorized as serious adverse events among alvimopan-treated patients, the companies said.

As the findings outlined were observed during the preliminary evaluation of data from Study 014, and a full analysis has not yet been completed, further details are not yet available. Additional data are being collected and further analyses, which will include all alvimopan OBD studies, will be undertaken as soon as possible to better understand these findings.

Pending completion of these analyses, the protocol for an additional Phase III safety and efficacy study (Study 015), which had been submitted to regulatory authorities, is being withdrawn by GSK. The company has also decided to stop Study 101684, an extension of Study 008 in a cancer pain population, which currently has 15 patients receiving treatment. Clinical investigators involved in this study have been informed.

Adolor has also suspended enrollment in Study 228 in rotator cuff surgery patients until a more complete understanding of these data are available. GSK and Adolor have no other ongoing studies involving alvimopan.