Tioga Pharmaceuticals, Inc.’s 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, PhD, chairman and chief executive officer of Tioga Pharmaceuticals.
Release Date: June 1, 2011
Source: Tioga Pharmaceuticals
Filed Under: Drug Discovery