Furiex Pharmaceuticals, Inc. (Nasdaq: FURX) today announced that its novel diarrhea-predominant irritable bowel syndrome treatment called MuDelta, now in Phase II clinical trials, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA).
“We are extremely pleased our MuDelta program has been granted Fast Track designation by the FDA”
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.
"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."
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