GSK and Adolor see good Entereg data

UK-based drug major GlaxoSmithKline and US biopharmaceutical company Adolor, a specialist developer of products for pain management, have unveiled positive Phase IIb data from trials of their co-developed drug Entereg (almivopan) as a treatment for opioid-induced gastrointestinal side effects in chronic pain patients. The data were presented at the American Pain Society meeting in San Diego, earlier this month.

The findings are from a six-week double-blind study that enrolled 522 patients who use opioids as a treatment for non-cancer pain. The researchers found that the average increase in spontaneous bowel movements, defined as a motion in the absence of laxatives, ranged from 3.5-4.3 in the various drug treated groups, versus 1.7 in the placebo cohort. The improvement was maintained throughout the trial's duration.

The companies said that patients taking the drug also experienced a reduction in abdominal pain and bloating. Adverse events observed included nausea and diarrhea, occurring at a similar frequency in the 0.5mg drug-treated arm and the placebo group, while those subjects receiving the 1mg dose saw an increase in the frequency of such events.