Furiex Pharmaceuticals Reports Positive Results In Phase III Trials for Eluxadoline
By Cyndi Root
Furiex Pharmaceuticals, Inc. announced in a press release that Eluxadoline has met its primary endpoint in two Phase III trials. Eluxadoline treats diarrhea-predominant irritable bowel syndrome (IBS-D). The company states that results met the formal endpoint requirements of both the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The endpoint of abdominal pain and stool consistency improvement meets the FDA’s and EMA’s guidance on drug discovery for IBS. Fred Eshelman, founding chairman of Furiex said, "In just under four years, working closely with regulatory authorities, the team has completed nine Phase I studies, a Phase II dose-ranging trial in approximately 800 patients, and these two large Phase III trials.” He added that the company is on track to submit the New Drug Application (NDA) shortly.
Irritable Bowel Syndrome
Irritable bowel syndrome (IBS) is a group of varying symptoms that alter gastrointestinal function. Symptoms must occur at least three times a month and include a hard or watery stool, more frequent or less frequent bowel movements, diarrhea, constipation, bloating, or mucus in the stool. IBS has subtypes with different symptoms and treatments: IBS with constipation (IBS-C), IBS with diarrhea (IBS-D), and Mixed IBS (IBS-M), Unsubtyped IBS (IBS-U). The syndrome affects up to 15% of the population, however only up to 7% are diagnosed. Women have the syndrome twice as much as men and it is mostly found in populations younger than 45 years old. IBS-D, with diarrhea, can severely limit the quality of life and patients have limited treatment options.
Eluxadoline
Eluxadoline is an investigational agent with dual opioid receptor agonist abilities. For maximum effectiveness, it is low in oral bioavailability and instead works in the gastrointestinal system. The two opioids treat the pain and the diarrhea, without debilitating constipation. The FDA granted the drug expedited review, signifying the promise of the treatment and the unmet need it would serve.
Clinical Studies
Studies 3001 and 3002 were placebo-controlled studies. About 2,500 patients participated in the studies. Some people received eluxadoline, 75 mg or 100 mg two times a day or a placebo. Eluxadoline-treated patients responded better than the placebo and had significantly higher rates of stool consistency response. Patients tolerated the medication and the drug proved safe. Side effects included nausea and constipation.
Source:
http://investor.furiex.com/releasedetail.cfm?ReleaseID=822849