GSK and Adolor report mixed results for bowel drug

The first study 012 reported a change in the average weekly frequency of spontaneous bowel movement. Good results were also noted in the investigation of the effect of alvimopan in patients with cancer pain treated with opioid analgesics. Alvimopan treatment in this study resulted in greater increases in spontaneous bowel movement frequency than placebo.

However Study 013 did not achieve statistical significance.

“These results are encouraging for the millions of people currently using opioids chronically. 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,” said Yvonne Greenstreet, senior vice president of GlaxoSmithKline.

Alvimopan was generally well tolerated in these studies. Adverse events affecting the gastrointestinal tract were the most common in both studies occurring in 24-33% of alvimopan-treated patients, compared with 22% on placebo. These included abdominal pain, diarrhea, nausea and vomiting and the incidence was generally similar between alvimopan and placebo groups. There was no evidence of antagonism of opioid analgesia based upon pain intensity scores and opioid consumption.