Sucampo Pharmaceuticals Inc has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration for its proprietary agent SPI-0211, a novel chloride channel activator, in treating postoperative ileus (POI).
The IND submission includes a protocol for a double-blind, placebo-controlled Phase II safety and efficacy study. Subjects with POI will be randomized into three treatment groups at two U.S. sites.
POI is a transient impairment of bowel motility that occurs following surgical procedures, particularly those that involve the colon. The condition causes patient discomfort, decreased motility, increased risk of complications, delayed enteral feeding, diminished healing and prolonged hospitalization. The ultimate consequence of POI is an increased cost of surgical recovery, estimated at $1.1 billion annually in the United States. "Our FDA submission is another significant milestone in our comprehensive development program for this promising proprietary agent," said Sucampo Chair and CEO Ryuji Ueno.
Sucampo announced it had begun a phase II study for the treatment of constipation-predominant irritable bowel syndrome with SPI-0211 late last month. The company announced Phase III efficacy and safety trial results last November that demonstrated the agent performed significantly better than placebo in treating occasional constipation.