Salix says FDA approves Fulyzaq 125mg delayed-release tablets Salix Pharmaceuticals announced that the FDA has approved Fulyzaq 125 mg delayed-release tablets for the symptomatic relief of non-infectious diarrhea in adult patients with HIV/AIDS on anti-retroviral therapy. The FDA 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 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. Patients who received concomitant anti-diarrheal medications or opiates were counted as clinical non-responders. Salix currently plans on making Fulyzaq accessible to patients with HIV/AIDS on anti-retroviral therapies suffering from non-infectious diarrhea in early 2013.