Furiex Pharmaceuticals, Inc. (Nasdaq: FURX) 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).

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."

About MuDelta

MuDelta is a novel mu-opioid receptor agonist and delta-opioid receptor antagonist being studied for the treatment of diarrhea-predominant irritable bowel syndrome. The early pre-clinical and Phase I clinical data for MuDelta suggest this combination of opioid modulators may provide effective relief for both pain and diarrheal symptoms of IBS-d without the constipating effects typically seen with mu receptor agonists. Pharmacology data suggest that MuDelta acts locally in the digestive tract, thus having a low potential for systemic side effects.

Diarrhea-predominant irritable bowel syndrome, or IBS-d, is characterized by chronic abdominal pain and frequent diarrhea and affects approximately 12 million Americans. IBS-d is associated with a large unmet medical need. The exact cause of IBS-d is not known. Symptoms are thought to result from a disturbance in the way the gut, brain and nervous system interact, which in turn causes changes in normal bowel movement and sensation. IBS-d imposes a substantial economic burden in direct medical costs and indirect social costs such as absenteeism and lost productivity, along with less-measurable costs of a decreased quality of life.

Source:
Furiex Pharmaceuticals