First patient dosed in Ph III lubiprostone trial

The USA's Sucampo Pharmaceuticals and the US unit of Japanese drug major Takeda say that the first patient has been enrolled in a Phase III study of lubiprostone (24mcg, oral gel capsules, twice daily) for the treatment of opioid-induced bowel dysfunction.

The OPAL program consists of two 12-week, double-blind studies, followed by a nine-month open-label safety extension study. The trials are expected to enroll approximately 840 patients at up to 190 sites in the USA and Canada and will evaluate the effects of lubiprostone as a treatment for constipation stemming from the use of narcotic medications, such as morphine and codeine, prescribed for chronic pain management.

The agent is a chloride channel activator developed by Sucampo that is currently approved for the treatment of chronic idiopathic constipation in adults, as Amitiza, and is under US review for irritable bowel syndrome with constipation.