Salix Pharmaceuticals announced today that a Food and Drug Administration advisory panel supports the proposed design of a clinical trial to evaluate the effectiveness of the company's drug Xifaxan in treating irritable bowel syndrome.
Salix expects to begin patient enrollment for the trial in the first quarter of next year. The company estimates it could take 24 months to complete the trial and file a resubmission with the FDA.
Trading in Salix shares was halted today in advance of the FDA ruling.
Salix shares have swung widely in recent months whenever major news about its IBS application came out. The company has said winning approval to market Xifaxan for treatment of IBS could mean $2.5 billion a year in new sales.
Today's news is good news for Salix as there were some concerns that the FDA might require a more extensive review.
FDA officials released briefing documents Monday that included questions about whether Salix used the proper dose and proper patient population in its testing.
"We are extremely pleased with the advisory committee's support of the proposed study design elements for a repeat treatment protocol proposal," said Bill Forbes, Salix's executive vice president in charge of medical, research and development, in a statement.
The FDA had earlier expressed concerns that Salix's application included no data on whether patients would respond to repeated use of the treatment.