Botanical Drug

FDA Approves Crofelemer as First-Ever Oral Botanical Drug​

On New Year's Eve of 2012, the US Food and Drug Administration (FDA) announced its approval of crofelemer (Fulyzaq™, Salix Pharmaceuticals, Ltd., Raleigh, North Carolina) — marking the second time a botanical, and the first time an orally administered botanical, has received drug approval from the Administration. The first botanical drug to be approved in the United States was a topical green tea extract, Veregen®, in 2006. Both botanical drugs meet all US pharmaceutical requirements and can be dispensed only by prescription.

Crofelemer is the first drug to be approved in the United States to treat HIV-associated diarrhea.(1) It is derived from the latex of the South American sangre de drago tree (dragon's blood, Croton lechleri). A red, blood-resembling latex leaks from the tree when its bark is cut, and it is this substance that contains the novel polymolecular structure crofelemer, originally developed and standardized by Shaman Pharmaceuticals.

According to FDA's press release regarding the approval, "The safety and efficacy of Fulyzaq were established in a clinical trial of 374 HIV-positive patients on stable antiretroviral therapy [ART] with a history of diarrhea lasting one month or longer... 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."

The herbal medicine and pharmaceutical communities have been expressing satisfaction with FDA's decision, ushered out the door on the last day of the year — an action typical of FDA efforts to complete pending drug reviews before the end of each calendar year. Salix, which owns the license for crofelemer's development and submitted the product's New Drug Application (NDA) for review, called the approval a "significant step forward in addressing the unmet medical need of people with HIV/AIDS on ART who experience non-infectious diarrhea." According to a Salix press release, the company expects Fulyzaq to be available to patients in early 2013. A Bloomberg analysis estimates crofelemer will bring the company sales of $18 million in 2013 and $26 million in 2014. Napo Pharmaceuticals (San Francisco, California), the company that owns the intellectual property rights of the drug, will issue comments in the coming days (S. King, email, January 2, 2013). Glenmark Pharmaceuticals, Ltd., the India-based manufacturer and supplier of crofelemer for the US market, experienced an increase in market shares of 3.4% following the announcement.