Salix Pharmaceuticals took a body blow from FDA, as the agency refused to broaden use of its bowel drug Xifaxan. Widely expected to win an indication for use in irritable bowel syndrome, Xifaxan is now approved for traveler's diarrhea and for a rare brain disorder caused by liver failure, Bloomberg reports.
Last month, research published in the New England Journal of Medicine showed that Xifaxan helped ease IBD symptoms, and that data raised expectations that FDA would come through with an approval. "I wouldn't ever call an FDA action a slam dunk, but certainly expectations were sky high," Jeffries analyst Corey Davis told the news service. "There have been very few drugs I can think of that had a publication in NEJM and then subsequently never received FDA approval. Salix got sucker punched by the FDA."
Salix said it expects a complete response letter from the FDA, which said the new indication isn't ready for prime time because of "a newly expressed need for re-treatment." No word on whether the FDA wants a new trial. And that, of course, is a key question, because running a new study could take lots of time and millions of dollars.
- see the Bloomberg coverage