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FDA Grants Fast Track Designation to Tioga Pharmaceuticals' Asimadoline for the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome
Date:6/1/2011

SAN DIEGO, June 1, 2011 /PRNewswire/ -- Tioga Pharmaceuticals, Inc. announced today that its investigational compound asimadoline has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with diarrhea-predominant irritable bowel syndrome (D-IBS). Tioga is conducting a multi-center Phase 3 clinical trial evaluating asimadoline in D-IBS, conducted under a Special Protocol Assessment agreement with the FDA for U.S. registration.

The Fast Track program is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life threatening conditions and that demonstrate the potential to address unmet medical needs. New drug applications for products in the Fast Track program ordinarily are eligible for priority review.

"The FDA's granting of Fast Track designation for asimadoline signals the agency recognizes that diarrhea-predominant irritable bowel syndrome is a serious illness and that patients lack a safe and effective therapy," said Stuart Collinson, Ph.D., Chairman and CEO of Tioga Pharmaceuticals.

For information about Tioga Pharmaceuticals' Phase 3 D-IBS trial, go to www.clinicaltrials.gov.

About Irritable Bowel Syndrome

Irritable bowel syndrome (IBS) is a common, chronic gastrointestinal disorder characterized by recurrent episodes of abdominal pain or discomfort associated with a change in bowel pattern, such as loose or more frequent bowel movements, diarrhea and/or constipation. While the exact etiology of IBS is unknown, it is believed to be due to a disturbance in the interaction between the intestines, the brain and the autonomic nervous system that alters regulation of bowel motility or sensory function. IBS patients fall into different subtypes based on their predominant symptoms: IBS with diarrhea (D-IBS), IBS with c
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SOURCE Tioga Pharmaceuticals, Inc.
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