Furiex treatment meets late-stage study goals
Shares of Furiex Pharmaceuticals more than doubled Tuesday after reporting that its treatment for a form of irritable bowel syndrome met key goals in late-stage study, and that the drug is on track for submission to regulators later this year.
The structure of the recently completed research on eluxadoline had already been agreed to by both the U.S. Food and Drug Administration and the European Medicines Agency.
The treatment is intended to ease abdominal pain for patients with diarrhea-prominent irritable bowel syndrome, and improve stool consistency.
Two studies involving more than 2,400 patients compared different doses of the treatment against a placebo.
The company said about 28 million patients are affected by this particular form of irritable bowel syndrome in the United States and major European markets.
The Furiex treatment had received an FDA fast-track designation, which is designed to speed up the development and review of drugs that treat diseases with significant and unmet medical need.
The company said it was on track to apply for the drug's approval by the end of the second quarter.
Shares of Furiex Pharmaceuticals Inc. climbed $68.01 to $113.98 after markets opened Tuesday morning.