The opioid-induced bowel dysfunction (OBD) pivotal assessment of lubiprostone (OPAL) program is designed to evaluate the effect of lubiprostone as a treatment for chronic pain patients suffering from constipation and associated symptoms as a result of chronic opioid therapy.
The OPAL program consists of two double-blind, randomized, placebo-controlled trials, and a follow-on nine-month, open-label, safety extension study. A total of 875 patients diagnosed with OBD were enrolled at 187 sites in the US and Canada. Patients will receive one 24-mcg gel capsule of lubiprostone twice a day or placebo for 12 weeks. The primary endpoint of the trial is the change from baseline in the frequency of spontaneous bowel movements at week eight.
Ryuji Ueno, founder, chairman, and CEO of Sucampo, said: “If lubiprostone is successful in Phase III, we believe that it could represent a breakthrough in the treatment of patients suffering from OBD. We have completed enrollment of both pivotal trials of lubiprostone for opioid-induced bowel dysfunction. We are on track to have top-line data from the 12-week treatment period of the program next summer.
“If the efficacy results are positive, the follow-on nine-month open-label safety study would report top-line results in late 2009. We anticipate filing a supplemental new drug application submission to the FDA during 2010, assuming positive efficacy and safety results.”