Salix Pharmaceuticals finally received formal U.S. Food and Drug Administration notice that the agency would not approve the company’s irritable bowel syndrome drug, but so far, the company is saying little else.
Morrisville, North Carolina-based Salix (NASDAQ:SLXP) said it would request a meeting with the FDA to discuss the drug Xifaxan. Salix said that until the meeting is held and the company has an opportunity to evaluate its options, Salix cannot plan future development of Xifaxan for nonconstipation irritable bowel syndrome.
Salix, a specialty pharmaceutical company focusing on gastrointestinal treatments, said it received the FDA’s complete response letter the evening of March 7. The company had disclosed on Feb. 24 that the FDA indicated it would be sending a complete response letter regarding Xifaxan, news that sent Salix shares into a dive. Such letters typically outline why the FDA cannot approve a drug and what the FDA needs to see in order for the drug to gain approval.
Xifaxan is already approved for treating traveler’s diarrhea as well as hepatic encephalopathy, a brain disorder associated with severe liver disease. Salix had been seeking to add nonconstipation irritable bowel syndrome as a new indication for the drug. If the FDA requires additional clinical trials on Xifaxan, that would mean more time and money spent on the drug.
Salix did not disclose the contents of the FDA letter, nor has the letter been filed with the company’s securities filings. Salix said that it will provide its next update during the first-quarter earnings conference call, which is scheduled for early May.
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