FDA committee recommends expanded use of Salix drug

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Local Tech Wire

RALEIGH, N.C. – A Food and Drug Administration committee voted 14-4 Tuesday to support expanded use of the anti-diarrhea drug Xifaxan from (Nasdaq: SLXP).

The vote came after reports on Friday had indicated the application might not be approved due to concerns about safety. The news sent Salix shares down 14 percent in trading on Friday and Monday, leading the Nasdaq to order a halt to trading in the shares on Tuesday.

Salix wants to use Xifaxan to combat hepatic encephalopathy, which is neurological damaged caused by liver failure.

“We are very pleased with the advisory committee’s support for the approval of Xifaxan,” said Bill Forbes, senior vice president for research and development at Salix, in a statement.

“If approved, Xifaxan will be the first new option for the management of hepatic encephalopathy in over 30 years,” he added.

The FDA must still approve the drug but generally follows its advisory committee recommendations.

Shares closed at $24.25 and declined another 40 cents in after-hours trading Monday night.