Administered orally, the agent has been shown to work locally in the GI tract by activating specific chloride channels (a protein that carries chloride) on cells lining the small intestine, increasing intestinal fluid secretion. This increased fluid level softens the stool, promotes spontaneous bowel movements, and reduces abdominal discomfort, pain and bloating.
"This NDA submission marks a significant product milestone in Sucampo's history. We believe lubiprostone could provide an important new treatment option for the millions of people who suffer from chronic constipation and its difficult symptoms," said Sachiko Kuno, Ph.D., president and chief executive officer of Sucampo. "Our studies suggest that lubiprostone's unique mechanism of action may offer a more targeted approach to managing the symptoms of constipation."
Once the FDA grants approval, Takeda Pharmaceutical Company's U.S. subsidiary will market lubiprostone in the U.S. Sucampo and Takeda reached an agreement in October 2004 that provided Takeda marketing rights for the U.S. and Canada for the agent in the gastroenterology indications, as well as the option for marketing rights in other territories, including Japan and Europe. R-Tech Ueno, Ltd (Tokyo, Japan), a member of Sucampo Group, will manufacture and supply the drug.
For the NDA application, Sucampo provided results from two Phase III pivotal efficacy studies, results of a randomized withdrawal (RW) study and three long-term safety studies, including two 12-month safety studies. Th