Diarrhea is experienced by many HIV/AIDS patients and is a common reason why patients discontinue or switch their anti-retroviral therapies.
Dr. Julie Beitz, director of the Office of Drug Evaluation III in FDA's Center for Drug Evaluation and Research, said Fulyzaq, or crofelemr, 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.
"Currently, there are no FDA-approved therapies for HIV-associated diarrhea," Beitz said in a statement. "Fulyzaq may be helpful to HIV/AIDS patients with this troublesome condition."
The safety and efficacy of Fulyzaq were established in a clinical trial of 374 HIV-positive patients on stable anti-retroviral 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. Patients were randomly assigned to take Fulyzaq or a placebo twice daily.
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