The FDA approval of Fulyzaq™ is based on a randomized, double-blind, placebo-controlled (one month) and placebo-free (five month), 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.
Data demonstrated that a significantly larger proportion of patients taking Fulyzaq™ 125 mg twice daily experienced clinical response compared with patients in the placebo group. In addition, statistically significant reductions from baseline to the end of the double-blind period also were observed for the number of watery bowel movements per day, and daily stool consistency score, among patients taking Fulyzaq™ compared with placebo. Further, the Fulyzaq™ treatment effect for clinical response (125 mg twice daily vs. placebo) was similar in subgroup analyses based on duration of diarrhea, baseline number of daily watery bowel movements, use of protease inhibitors (PI), and CD4 cell count. The most common adverse reactions in the study were respiratory tract infection, bronchitis, cough, flatulence, and increased bilirubin.
Patents for Fulyzaq™ should provide intellectual property protection to 2018. With this approval, Fulyzaq™ is eligible for market exclusivity for five years as a new molecular entity in the United States. Because Fulyzaq™ is a new molecular entity Salix believes the product may be entitled to patent term restoration. Fulyzaq™ is a first-in-class gastrointestinal agent of botanical origin. Fulyzaq™ is not available synthetically and Salix has the right to the manufacturing process for producing Fulyzaq™ from the biologic source.
Salix currently plans on making Fulyzaq™ accessible to patients with HIV/AIDS on anti-retroviral therapies suffering from non-infectious diarrhea in early 2013.