"We are pleased with this NDA submission by our partner Sucampo, as it surely will support the realization of our ongoing commitment to providing new and innovative options to physicians and their patients," said Yasuchika Hasegawa, president and chief operating officer at Takeda.
In addition to the NDA indication, Sucampo has completed a Phase II trial that studied lubiprostone for constipation-predominant irritable bowel syndrome (IBS-C). The company expects the agent to enter Phase III trials soon. Lubiprostone also is being evaluated for other GI indications.
About Constipation and Chronic Constipation
Constipation, defined as infrequent and difficult passage of stool, is one of the most common disorders suffered by Americans. It affects between two to 27 percent of the population in Western countries. In the United States, it results in more than 2.5 million visits to physicians and 92,000 hospitalizations annually. Factors contributing to the development of constipation include not enough fiber in the diet, lack of exercise, irritable bowel syndrome, neurological and systemic disorders and problems with the colon and rectum or intestinal function. Other contributing factors include side effects from medication, particularly pain medications, antidepressants, antacids, antispasmodics and blood pressure medications. Other contributing factors include side effects from medication, particularly narcotic analgesics, antidepressants, anticholinergics, antispasmodics and antihistamines. Chronic constipation is a disorder of colonic motility that is present for at least three months and result