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Second Phase III Efficacy Study Completed for SPI-0211, Treatment for Constipation
BETHESDA, Md., Jan. 12 /PRNewswire/ -- Sucampo Pharmaceuticals, Inc. (http://www.sucampo.com/), a leader in functional fatty acid research and development, announced today it has completed the second of two Phase III pivotal efficacy studies to support the new drug application for its proprietary chloride channel activator, SPI-0211, in treating constipation.
The study's database has been locked and its results duplicated the highly significant results of the first efficacy trial presented last May at the Digestive Disease Week 2003 Conference in Orlando.
The Sucampo trial randomized 237 patients with documented constipation into two treatment groups (one treated with a dose of 24 micrograms SPI-0211 twice daily, the other treated with placebo twice daily) at 20 sites throughout the United States.
"Constipation is a common and bothersome gastrointestinal condition affecting nearly 5.3 million Americans," said Sucampo CEO Myra L. Patchen, Ph.D. "Current treatment options are often poorly tolerated or ineffective. Based on the potent and consistent effects we have observed with SPI-0211 in our clinical trials, we are confident that it should provide a new therapeutic option in this underserved market."
Constipation is defined as infrequent and difficult passage of stool. In the United States, nearly 2.5 million physician visits per year are due to bouts of constipation. According to IMS Health, the constipation market exceeded $550 million in 2002.
In December 2003, the company completed its second open-label safety study for the treatment of constipation with SPI-0211. Sucampo's last open-label safety study is ongoing, and will end in Q3, 2004. Last April, Sucampo initiated a Phase II multi-center, safety and efficacy study for the treatment of constipation-predominant irritable bowel syndrome (IBS) with SPI-0211. It also recently initiated a Phase II study of SPI-0211 in treating postoperative ileus.
Source: Sucampo Pharmaceuticals, Inc.