An irritable bowel syndrome treatment that Salix Pharmaceuticals expected would be approved by early March now looks like it won’t get the OK from the U.S. Food and Drug Administration.
Morrisville, North Carolina-based Salix (NASDAQ:SLXP) said that based on a telephone conversation with the FDA on Wednesday evening, a complete response letter is expected on or before the March 7 target date for a supplemental new drug application for Xifaxan. The FDA issues such letters when it needs more information in order to approve a drug.
When Investment Rhymes with Canada
Canada has a proud history of achievement in the areas of science and technology, and the field of biomanufacturing and life sciences is no exception.
The news is a blow to Salix, which just last month had favorable Xifaxan results published in the New England Journal of Medicine. Salix said in a prepared statement that until the company receives the FDA letter, Salix has limited information about what the FDA requires. The company said only that based on the telephone conversation, the company understands that the FDA deems that the Xifaxan application “is not ready for approval primarily due to a newly expressed need for re-treatment information.” The company said it would consider its next steps after receiving the FDA response letter.
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 irritable bowel syndrome as another indication for the drug.
Investors did not welcome the Xifaxan news and shares of Salix on Thursday fell 22.35 percent from Wednesday’s close to trade at $32.18 per share.
Related articles
- Salix Pharmaceuticals pays $60m up front for constipation drug Relistor (medcitynews.com)
- Furiex IBS drug gets FDA fast track designation (medcitynews.com)
