FDA approves Fulyzaq (Salix Pharmaceuticals) for Diarrhoea in HIV/AIDS

The FDA has approved Fulyzaq (crofelemer 125 mg delayed-release) tablets, from Salix Pharmaceuticals, for the symptomatic relief of Diarrhoea in patients with HIV/ AIDS. Approval is based on a randomized, double-blind, placebo-controlled and placebo-free, multi-center study of 374 HIV-positive patients on antiretroviral therapy (ART), with a history of Diarrhoea for one month or more. The primary efficacy endpoint was the proportion of patients experiencing less than or equal to two watery bowel movements per week, during at least two of the four weeks of the placebo-controlled phase of the study.

Data demonstrated that a significantly larger proportion of patients taking Crofelemer experienced clinical response compared with patients on placebo. In addition, statistically significant reductions from baseline were observed for the number of watery bowel movements per day, and daily stool consistency score, among patients taking Crofelemer compared with placebo.