First anti-diarrheal drug for HIV/AIDS patients receives FDA approval

SPRING SPRING, Md. — The U.S. Food and Drug Administration on Monday approved Fulyzaq (crofelemer) to relieve symptoms of diarrhea in HIV/AIDS patients taking antiretroviral therapy, a combination of medicines used to treat HIV infection. Diarrhea is experienced by many HIV/AIDS patients and is a common reason why patients discontinue or switch their antiretroviral therapies.



Fulyzaq is intended to be used in HIV/AIDS patients whose diarrhea is not caused by an infection from a virus, bacteria or parasite. Patients take Fulyzaq two times a day to manage watery diarrhea due to the secretion of electrolytes and water in the gastrointestinal tract. 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.



The safety and efficacy of Fulyzaq were established in a clinical trial of 374 HIV-positive patients on stable antiretroviral therapy with a history of diarrhea lasting one month or longer. The median number of daily watery bowel movements was 2.5 per day. 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.



Fulyzaq is distributed by Salix Pharmaceuticals, based in Raleigh, N.C. under license from Napo Pharmaceuticals Veregen is marketed by Florham Park, N.J.-based PharmaDerm.