Botanical drug, Fulyzaq receives FDA approval to treat diarrhea in HIV/AIDS patients on antiretroviral therapy
The US Food and Drug Administration (FDA) announced today the approval of Fulyzaq (crofelemer) to relieve symptoms of diarrhea in HIV/AIDS patients taking antiretroviral therapy, a combination of medicines used to treat HIV infection, according to a FDA press release Dec. 31.
Derived from the red sap of the Croton lechleri plant, Fulyzaq is the second botanical prescription drug approved by FDA. A botanical drug product is often a complex mixture derived from one or more plant materials with varying degrees of purification.
Fulyzaq is distributed by Salix Pharmaceuticals, based in Raleigh, N.C. under license from Napo Pharmaceuticals, Inc.
According to the FDA, many HIV/AIDS patients who take antiretroviral therapies experience diarrhea as a side effect. This causes some patients to stop taking their medications or switching to other medications.
Taking Fulyzaq two times a day can help manage diarrhea due to reasons other than viral, bacterial or parasitic infections.
“Currently, there are no FDA-approved therapies for HIV-associated diarrhea,” said Julie Beitz, M.D., 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 FDA advises health care providers before treating diarrhea with Fulyzaq, ensure testing is performed to rule out infectious agents as the cause of the diarrhea.
Veregen (sinecatechins) was the first FDA approved botanical prescription drug, approved in 2006 to treat external genital and perianal warts.