Salix Wins FDA Approval of Dragon’s Blood Drug for Diarrhea

Salix Pharmaceuticals Ltd. (SLXP), a maker of gastrointestinal drugs, won U.S. clearance to sell Fulyzaq, the first approved medicine to treat HIV-associated diarrhea.

The Food and Drug Administration approved the Raleigh, North Carolina-based company’s application to sell Fulyzaq, or crofelemer, to people with the virus that causes AIDS. Diarrhea is a common reason why those with HIV stop or switch antiretroviral therapies, the agency said in a statement today.

Derived from the crimson-colored sap of the Dragon’s Blood tree, the first-of-a-kind drug is also the second botanical prescription medicine approved by FDA. Salix, which got about 69 percent of its $540 million in sales last year from the antibiotic Xifaxan, has said the U.S. HIV-associated diarrhea market represents a $300 million-a-year opportunity.

Analysts estimated that crofelemer may add about $18 million in sales in 2013 and $26 million in 2014, according to the average of seven estimates compiled by Bloomberg.

An FDA decision on the company’s treatment had been delayed twice this year, including postponement of a September target date.

To contact the reporters on this story: Anna Edney in Washington at aedney@bloomberg.net; Romaine Bostick in Washington at rbostick@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net

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