A novel irritable bowel syndrome drug being developed by Furiex Pharmaceuticals is now on a faster path to possible approval, having received fast track designation by the Food and Drug Administration.
Morrisville, North Carolina-based Furiex (NASDAQ:FURX) announced the fast track designation on Monday. The company is currently in phase II clinical trials for MuDelta, which is being developed for diarrhea-predominant irritable bowel syndrome, or IBS-d. The condition is characterized by chronic abdominal pain and frequent diarrhea and affects an estimated 12 million Americans. The exact cause is not known, though symptoms are thought to be related to a disturbance in the way the gut, brain and nervous system interact.
“The agency recognizes a significant unmet need for new treatment of diarrhea-predominant irritable bowel syndrome,” Dr. June Almenoff, president and chief medical officer of Furiex said in a prepared statement. “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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Fast track designation is a process established by the FDA to speed the review of drugs that treat serious diseases and fill unmet medical needs. Furiex said early pre-clinical and phase I data suggest MuDelta may provide relief for pain and diarrheal symptoms without the constipating effects seen with other treatments. Data also suggest that MuDelta acts locally in the digestive tract, which gives it a low potential for systemic side effects.
Furiex started as the “discovery sciences” division of Wilmington, North Carolina-based clinical research organization PPD. The division partnered with pharmaceutical companies to discover and develop new drugs. PPD chose to focus on its core business of providing contract services to the pharma industry and last year spun Furiex off into a separate company, giving Furiex $100 million to start its operations.
