Oral Botanical Drug First Ever to Gain FDA Approval

January 2, 2013

News of the approval came on December 31, 2012.

Crofelemer, an orally administered, botanical-derived drug for treating HIV-associated diarrhea, has become the first FDA-approved oral botanical drug. The prescription-only drug is marketed under the brand name Fulyzaq by Salix Pharmaceuticals Ltd. (Raleigh, North Carolina). News of the approval, which FDA issued on December 31, 2012, was shared by nonprofit educational group the American Botanical Council (ABC; Austin, TX).

In its press release announcing the crofelemer approval, FDA said its review included that of a clinical trial of 374 HIV-positive patients that showed 17.6% of patients on Fulyzaq “experienced clinical response” compared to the 8% of the placebo group. Crofelemer is derived from the South American sangre de drago tree (Croton lechleri), ABC says.

“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, in the FDA press release. “Fulyzaq may be helpful to HIV/AIDS patients with this troublesome condition.”

According to ABC, crofelemer is only the second botanical drug to be approved by FDA. The first was a topical green tea extract called Veregen. ABC says it will report further on the crofelemer approval in the January issue of its HerbalEGram monthly e-newsletter.

For more details on the story, visit ABC’s website.