FDA Approves Second Botanical Drug

SILVER SPRING, MDU.S. Food and Drug Administration (FDA) approved Fulyzaq, the first anti-diarrheal drug for HIV/AIDS patients. Fulyzaq (crofelemer) is only the second botanical drug approved by FDA. The agency approved the first botanical prescription drug, Veregen, in 2006.

Made from the sap of the Croton lechleri plant, this botanical drug helps users manage watery diarrhea due to the secretion of electrolytes and water in their gastrointestinal tract. FDA said a recent clinical trial of 374 HIV-positive patients established the safety and efficacy of the drug. In the study, nearly 18 percent subjects taking Fulyzaq twice daily experienced clinical improvements.

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 FDAs Center for Drug Evaluation and Research. Fulyzaq may be helpful to HIV/AIDS patients with this troublesome condition."

The approval boosts the botanical drug market, which is growing slower than expected regulatory challenges. A new report from BCC Research noted the industry's five-year compound annual growth rate (CAGR) will be 3.7 percent, as it grows from $22.1 billion in 2012 to an expected $26.6 billion in 2017. For more information on the market and the industry's response to growth estimations, read INSIDER article "Botanical Drug Market Hampered by Regulations."