Sucampo Pharmaceuticals Inc. surged 42 percent over two days after reporting that its experimental medicine for opioid-induced bowel dysfunction met goals in a late-stage clinical trial.
Sucampo climbed 16 percent to $6.24 as of the 4 p.m. in New York trading. The shares of the Bethesda, Maryland-based company had gained 23 percent yesterday after the trial results were released.
The medicine, lubiprostone, met the primary goal of the third and final stage of trials generally required for U.S. marketing clearance, Sucampo and partner Takeda Pharmaceutical Co. said yesterday in a statement. The companies plan to file for U.S. marketing clearance in the first half of this year.
Lubiprostone would be the first prescription pill for opioid-induced bowel dysfunction if approved, the companies said. It’s designed for the treatment of patients with chronic pain not related to cancer, excluding those taking methadone.
“OBD can be a painful and debilitating side effect affecting many non-cancer pain patients taking opioids chronically,” M. Mazen Jamal, a trial investigator, said in the statement. Jamal is chief of endoscopy at the Long Beach Veterans Affairs’ Medical Center in California. “Many patients are not getting the desired relief and there is a significant need for a new medicine to treat this condition.”
More than 200 million prescriptions are written each year for opioids in the U.S., Jamal said. “A substantial portion of these prescriptions are for non-cancer chronic pain,” he said.
The 12-week trial evaluated spontaneous bowel movement response rate in 439 patients. It found those on lubiprostone had a rate of 27 percent, compared with 19 percent for those on a placebo.
Lubiprostone is already approved for chronic constipation in adults and irritable bowel syndrome with constipation in women, marketed as Amitiza.
Sucampo is up 39 percent in the last 12 months.