MORRISVILLE, N.C.--(BUSINESS WIRE)--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).
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.”
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.
Furiex Pharmaceuticals is a drug development collaboration company using innovative clinical development design to accelerate and increase value of partnered drug programs by advancing them through the drug discovery and development process in a cost-efficient manner. Development programs are designed and driven by a core team with extensive drug development experience. The company collaborates with pharmaceutical and biotechnology companies and has a strong, diversified product portfolio and pipeline with multiple therapeutic candidates including clinical stage assets and two products on the market. The company’s mission is to develop innovative medicines faster and at less cost, reducing the expense of health care globally while providing life-improving therapies for patients. For more information, visit www.furiex.com.
Except for historical information, all of the statements, expectations and assumptions contained in this news release are forward-looking statements that involve a number of risks and uncertainties. Although Furiex attempts to be accurate in making these forward-looking statements, it is possible that future circumstances might differ from the assumptions on which such statements are based. In addition, other important factors which could cause actual results to differ materially include the following: the Fast Track designation does not decrease time required to gain FDA approval; the risks and expense of continuing the research and development activities of our existing candidates; progress of product candidates in clinical trials as it relates to receiving future milestone payments; the ability of our licensees to obtain regulatory approval and successfully manufacture and market products licensed under our patents; the continued or additional support by our collaborators or other third parties of R&D efforts and clinical trials; and the costs of defending or prosecuting any patent opposition or litigation necessary to protect our proprietary technologies; and the other risk factors set forth from time to time in the SEC filings for Furiex, copies of which can be found on our website.