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. Patients were randomly assigned to take Fulyzaq or a placebo twice daily.
The trial was designed to measure clinical response, defined as the number of patients who had two or fewer watery bowel movements weekly. 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 Raleigh, NC-based Salix Pharmaceuticals, under license from Napo Pharmaceuticals, Inc.