FDA approves 2nd botanical in 8 years, Fulyzaq from Salix

In 2004, the FDA created a pathway for drugmakers to get approval of drugs derived from plants. While it has received about 500 applications, it approved only one prescription botanical drug in the 8 years since, until today.

On the last day of the year, the FDA gave a thumbs up to the second botanical prescription drug it has ever approved, a full 6 years after the first was sanctioned. The recipient of this rare distinction was Fulyzaq, a drug marketed by Salix Pharmaceuticals ($SLXP) for the treatment of diarrhea in HIV/AIDS patients who are on anti-retroviral therapy.

The FDA pointed out that diarrhea is a common reason that HIV/AIDS patients discontinue or switch anti-retroviral treatments and that up to now there have been no FDA-approved treatments for the side effect.

Fulyzaq (crofelemer) is made from the red sap of the Croton lechleri plant, a South American tree referred to as the dragon's blood tree because of its red latex. The FDA pointed out that makers of botanicals not only have to show the safety and efficacy of their proposed products through clinical trials, but they must also demonstrate that proper agricultural and collection practices are followed and that the raw materials meet scrupulous standards. The only other botanical approved in the U.S. so far was in 2006, when the FDA OK'd Veregen (sinecatechins), an ointment for genital warts that is derived from green tea leaves. It was developed by Germany's MediGene.

The biggest market for botanicals is China, where they already are accepted. And some Big Pharma players are working on products there. GlaxoSmithKline ($GSK) is working with botanicals on products for immune disorders, while Sanofi ($SNY) wants to develop alternative meds for diabetes and cancer for sale there.

Salix has said the market in the U.S. for Fulyzaq is relatively small, only about $300 million. Salix licenses the drug from Napo Pharmaceuticals. 

- here's the FDA announcement