NEW YORK (AP) – Salix Pharmaceuticals Ltd. is preparing to meet with regulators about a potential new approval for its bowel drug.
Salix is trying to get marketing approval for Xifaxan as a treatment for irritable bowel syndrome. The company will meet with a Food and Drug Administration advisory panel to discuss development of the drug. The committee posted documents that will be used at the meeting, including the questions panelists will vote on. One analyst said the panel is asking unexpected questions that could complicate the drug’s path to approval.
Xifaxan is approved as a treatment for traveler’s diarrhea and for overt hepatic encephalopathy, or neurological problems associated with liver failure. Salix is hoping to get the FDA to approve the drug as a treatment for non-constipation irritable bowel syndrome, and bloating associated with the condition. The company estimates it could get approval about two years from now.
The FDA refused to grant the new approval in March and asked Salix for additional information. The panel will make a recommendation to the FDA about whether or not it should grant the new approval, but the FDA is not required to follow their advice.
Proposed questions for the FDA’s Gastrointestinal Drugs Advisory Committee include whether Salix should consider a testing different dose of Xifaxan for IBS, whether a new clinical trial design would be appropriate, how to define which patients could use the drug, and the panelists’ concerns about drug resistance.
“Issues were raised in the documents we were not aware of,” said Jefferies & Co. analyst Corey Davis. He said the panel seems unexpectedly skeptical about the Xifaxan as an IBS treatment, although he thinks the drug will ultimately be approved. He said a new approval
Date: November 14, 2011
Source: Associated Press
