New AMITIZA 8 mcg phase III studies demonstrated overall symptom improvement in adult women

New study results indicated that treatment with AMITIZA^® (lubiprostone) 8 mcg lead to significant relief of overall symptoms of Irritable Bowel Syndrome with Constipation (IBS-C). These results were presented at Digestive Disease Week (DDW) 2008, the largest annual international meeting of digestive disease specialists. “IBS-C is a multi-symptom disorder and is one of the most common conditions seen by gastroenterologists,” said William D. Chey, M.D., primary investigator of the study, University of Michigan Health System. “These data are important because they show that in studies, AMITIZA has demonstrated the ability to improve the overall symptoms reported by patients with IBS-C.”

AMITIZA 8 mcg was approved by the U.S. Food and Drug Administration (FDA) on April 29, 2008 for the treatment of IBS-C in women 18 years of age and older, and has been approved since 2006 at a 24 mcg dose for the treatment of Chronic Idiopathic Constipation in adults. These data were among others presented at DDW 2008 that evaluated the effect of AMITIZA for IBS-C.

“AMITIZA is the first ClC-2 channel activator and the only widely available FDA-approved agent for the treatment of IBS-C in adult women in the United States. AMITIZA could provide overall symptom relief for the millions of appropriate patients in the U.S. who suffer from this condition,” said Ryuji Ueno, M.D., Ph.D., Ph.D., founder, chairman and chief executive officer, Sucampo Pharmaceuticals (NASDAQ: SCMP). “We are pleased with the body of data on AMITIZA presented at DDW this year. Additional data presented at this meeting may help physicians better understand how to treat their patients with IBS-C.”

“AMITIZA makes it possible for appropriate patients to receive a widely available FDA-approved treatment for their IBS-C,” said Charles Baum, M.D., gastroenterologist and executive medical director, Gastroenterology and Internal Medicine, Takeda Pharmaceuticals North America, Inc.

Approximately 58 million Americans have Irritable Bowel Syndrome (IBS), and IBS-C accounts for approximately one-third of these cases. IBS-C is a chronic disorder characterized by abdominal discomfort or pain and changes in bowel habits including symptoms of constipation.

Source: Ketchum