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On December 31, 2012, the FDA announced the approval of crofelemer (Fulyzaq) to relieve symptoms of noninfectious diarrhea in HIV-infected patients taking antiretroviral therapy (ART). Derived from the sap of Croton lechleri, a plant native to northwestern South America, the drug is believed to act by inhibiting chloride secretion into the gut. The recommended dose is one 125-mg delayed-release tablet taken orally twice daily.
Approval was based on the results of a phase III, multicenter, double-blind study in which HIV-infected patients with noninfectious diarrhea were randomized to 125 mg of crofelemer twice daily or placebo. All participants were taking ART and had a history of diarrhea for at least 1 month. Eighteen percent of patients t…