Adolor Corporation announced the completion of enrollment in the first Phase 3 clinical trial (OBD 304) for use of its product candidate, alvimopan, in managing opioid induced bowel dysfunction. The study has enrolled 168 subjects who are chronic users of opioids, such as morphine and codeine, primarily for pain relief, and whose bowel function has been impaired as a side effect of their opioid use. For patients who take opioid analgesics over a long period of time for chronic pain, this impairment includes severe constipation, which often does not respond to laxatives or stool softeners.

Under the protocol, subjects in the study undergo a 21-day dosing period with a two-week follow-up. The results will be announced when the analysis of the study is completed. The plan is to complete the analysis in the fourth quarter of 2002; however, the process may require additional time. Additional studies will need to be conducted prior to filing any New Drug Application for use of alvimopan in this indication.

Alvimopan is also being studied in a separate Phase 3 program for postoperative ileus, an impairment of gastrointestinal motility after abdominal or other surgery. Adolor is developing alvimopan for opioid induced bowel dysfunction, postoperative ileus and certain other indications in collaboration with GlaxoSmithKline. Under the collaboration, GlaxoSmithKline will take over overall responsibility for development of alvimopan for management of patients with bowel dysfunction caused by chronic administration of opioids.