GlaxoSmithKline, Adolor alvimopan study shows improvement in opioid use-related GI symptoms

By Lisa Kerner

Erie, Pa., May 4 - GlaxoSmithKline and Adolor Corp. said patients in their phase 2b clinical study of alvimopan (Entereg) reported a significant improvement in common gastrointestinal (GI) symptoms associated with opioid use, including constipation, abdominal pain and bloating.

Alvimopan is an orally administered investigational drug that blocks peripheral mu-opioid receptors, according to a company news release.

In the double-blind study, 522 patients taking opioids for persistent non-cancer pain were randomized to four groups: alvimopan 0.5 mg twice a day, alvimopan 1 mg once a day, alvimopan 1 mg twice a day or a placebo for six weeks.

The increase in spontaneous bowel movements for each alvimopan dose group was double that of the placebo, became apparent within one week and was sustained throughout the six-week treatment period, GlaxoSmithKline said.

The most common adverse events reported were abdominal pain, nausea and diarrhea, with a frequency similar between the placebo and alvimopan treated patients at the 0.5 mg dose. Adverse events increased at the 1 mg dose of alvimopan.

Study participants were also assessed using the 28-question Patient Assessment of Constipation Quality of Life instrument.

Study results were presented at the American Pain Society Meeting in San Antonio.

GlaxoSmithKline is a research-based pharmaceutical and health care company based in London.

Located in Exton, Pa., Adolor is a biopharmaceutical company specializing in novel prescription pain management products.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.