First HIV-associated anti-diarrheal drug has been approved by FDA

Hannah Blake

pharmaphorum

The first anti-diarrheal drug for HIV /AIDS patients has been approved by the FDA for use in the United States. Fulyzag (crofelemer) has been approved to relieve symptoms of diarrhea in HIV / AIDS patients taking antiretroviral therapy, a combination of medicines used to treat HIV infection. Fulyzaq is distributed by Salix Pharmaceuticals, under license from Napo Pharmaceuticals, Inc.

“Currently, there are no FDA-approved therapies for HIV-associated diarrhea. Fulyzaq may be helpful to HIV/AIDS patients with this troublesome condition.”

Julie Beitz, M.D., director of the Office of Drug Evaluation III in FDA’s Center for Drug Evaluation and Research.

Fulyzag is derived from the red sap of the Croton lechleri plant and is the second botanical prescription drug approved by the FDA. A botanical drug product is often a complex mixture derived from one or more plant materials with varying degrees of purification. The first botanical prescription drug was approved by the FDA in 2006 and is called Veregen (sinecatechins), a treatment for external genital and perianal warts.

Just as for other types of drugs, the safety and efficacy of a botanical drug product are established through clinical trials. In addition, manufacturers of a botanical drug product must ensure rigorous control of raw materials, and good agricultural and collection practices, together with analytical testing of the complex mixture.

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. Patients who had diarrhea caused by an infection or a gastrointestinal disease were excluded from participating in the trials. 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.