Salix announced that the FDA has approved Fulyzaq (crofelemer) delayed-release tablets for the symptomatic relief of non-infectious diarrhea in adult patients with HIV/AIDS on anti-retroviral therapy (ART).

Crofelemer is a locally acting, minimally absorbed product that is believed to possess dual novel mechanisms of action that may be effective in treating both acute infectious diarrhea and chronic diarrhea.

The approval of Fulyzaq is based on a randomized, double-blind, placebo-controlled and placebo-free, multi-center study of 374 HIV-positive patients on ART with a history of diarrhea for >1 month. The primary efficacy endpoint was the proportion of patients experiencing <2 watery bowel movements per week, during at least two of the four weeks of the placebo-controlled phase of the study. Results showed that a significantly larger proportion of patients taking Fulyzaq experienced clinical response vs. patients in the placebo group.

Fulyzaq 125mg delayed-release tablets are expected be available in early 2013.

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