Salix wins FDA panel backing on Xifaxan

Shares of Salix reversed course in after-market trading yesterday evening, shooting up after the developer handily won an FDA expert panel vote backing the safety and efficacy of Xifaxan 550 mg tablets to treat hepatic encephalopathy.

By a vote of 14 to 4, the panel concluded that the data demonstrated that the drug appeared to benefit patients. But Reuters reports that it wasn't all clear sailing, as the panel noted that the trial didn't enroll the sickest patients or follow them long enough, given that they would be taking this drug for a considerable amount of time. Still, concluded UC San Diego's Richard Haubrich, "the potential benefits outweigh the risk." Salix's shares, which had sunk 14 percent ahead of the vote, jumped 18 percent on the news.

"If approved, Xifaxan 550 mg will be the first new option for the management of hepatic encephalopathy in over 30 years," says Bill Forbes, senior vice president R&D and chief development officer of Salix. "We believe the availability of Xifaxan 550 mg has the potential to change the treatment paradigm for HE. Today's independent recommendation from the outside experts comprising the advisory committee reinforces the Company's confidence in the potential for Xifaxan 550 mg to provide a solution for patients suffering from this serious condition."

- check out the Salix release
- here's the story from Reuters