February 8, 2012

HIV Diarrhea Drug Crofelemer Gets FDA Priority Review

The U.S. Food and Drug Administration (FDA) has granted Priority Review status to Salix Pharmaceuticals’ new drug application (NDA) for crofelemer tablets for HIV-associated diarrhea, according to a February 7 Salix announcement. Based on this review classification, the FDA must decide whether or not to approve the drug by June 5.

Crofelemer—which is based on a plant native to South America and is being sustainably harvested by growers there—acts by a different mechanism than current anti-diarrheal medications. Rather than being taken up systemically into the whole body, it acts locally in the gut and helps regulate the amount of water in the intestines. It also doesn’t interact with other medications.

“We are pleased with the FDA’s acceptance of the NDA for crofelemer and their decision to grant Priority Review for our application,” Bill Forbes, PharmD, a Salix executive vice president, said in the announcement. “This review classification signals that the FDA believes that crofelemer has the potential to provide a significant advance in the treatment of HIV/AIDS-associated diarrhea for patients on [antiretroviral therapy]. We believe the availability of crofelemer has the potential to change the treatment paradigm for HIV/AIDS patients suffering from diarrhea.”

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