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Furiex IBS Drug Gets Fast Track by FDA

MuDelta to get accelerated review

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Furiex Pharmaceuticals‘ application for MuDelta, a novel diarrhea-predominant irritable bowel syndrome treatment currently in Phase II, has been granted Fast Track designation by the FDA.

“We are extremely pleased our MuDelta program has been granted Fast Track designation by the FDA,” said June Almenoff, M.D., Ph.D., president and chief medical officer of Furiex. “The agency recognizes a significant unmet need for new treatment of diarrhea-predominant irritable bowel syndrome. We believe we are making significant progress with the Phase II trial, and this designation allows us to potentially get MuDelta to market faster.”

The FDA’s Fast Track program is designed to facilitate the development and expedite the review of new drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast Track designated drugs ordinarily qualify for priority review, thereby expediting the FDA review process.

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