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FDA Approves Botanical Drug for HIV/AIDS Patients

January 3, 2013

Fulyzaq, derived from the red sap of the Croton lechleri plant, is the second botanical prescription drug ever approved by the agency.

Diarrhea is experienced by many HIV/AIDS patients and is a common reason why patients discontinue or switch their antiretroviral therapies. To that end, the US FDA has approved Fulyzaq (crofelemer), which is derived from the red sap of the Croton lechleri plant, to relieve symptoms of diarrhea in HIV/AIDS patients taking antiretroviral therapy, a combination of medicines used to treat HIV infection.

“Currently, there are no FDA-approved therapies for HIV-associated diarrhea,” said Julie Beitz, MD, director of the Office of Drug Evaluation III in FDA’s Center for Drug Evaluation and Research. “Fulyzaq may be helpful to HIV/AIDS patients with this troublesome condition.”

The safety and efficacy of Fulyzaq were established in a clinical trial of 374 HIV-positive patients on stable antiretroviral therapy with a history of diarrhea lasting one month or longer. The median number of daily watery bowel movements was 2.5 per day. Patients who had diarrhea caused by an infection or a gastrointestinal disease were excluded from participating in the trials. Patients were randomly assigned to take Fulyzaq or a placebo twice daily.

The trial was designed to measure clinical response, defined as the number of patients who had two or fewer watery bowel movements weekly. Results showed that 17.6% of patients taking Fulyzaq experienced clinical response compared with 8% taking placebo. In some patients, a persistent anti-diarrheal effect was seen for 20 weeks.

Fulyzaq is distributed by Raleigh, NC-based Salix Pharmaceuticals, under license from Napo Pharmaceuticals, Inc. 

Fulyzaq is the second botanical prescription drug approved by FDA. In 2006, the FDA approved the first botanical prescription drug, Veregen (sinecatechins), a treatment for external genital and perianal warts marketed by Florham Park, NJ-based PharmaDerm.

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