GSK reports positive results for opioid-induced bowel disorder drug

GlaxoSmithKline (GSK) has announced the results of two trials for a treatment for opioid-induced bowel dysfunction (OBD) developed in conjunction with Adolor.

The drug, alvimopan, marketed as Entereg or Entrareg, was tested in two identically-designed phase III studies, entitled 012 and 013. Study 012 achieved statistical significance in its end point, as 72 per cent of patients using alvimopan achieved a weekly average of three or more spontaneous bowel movements, compared to 48 per cent receiving the placebo.

Study 013 failed to meet its primary endpoint, as 63 per cent of alvimopan patients met the target in comparison to 56 per cent of placebo patients. However, data from this study did support the secondary endpoint of change in average weekly frequency of spontaneous bowel movement.

Yvonne Greenstreet, senior vice-president of research and development at GSK, stated: “The effects on spontaneous bowel movement frequency as well as the overall safety and tolerability are consistent across all the alvimopan studies in this patient population and give a clear indication of potential benefit.

“We will continue to investigate the data to better understand the difference in the 013 study when compared with results from 012 and the earlier 011 study.”

“We remain focused on bringing this important new medicine to patients as soon as possible,” she added.

Opioid-induced bowel dysfunction is a common disorder affecting patients taking opioid painkillers like morphine.

Wyeth and Progenics have developed oral methylnaltrexone, another treatment for OBD, which was given fast-track status by the FDA in July.

© Adfero Ltd