Salix Pharmaceuticals, Ltd. (SLXP) Wednesday said the Food and Drug Administration approved Fulyzaq, or crofelemer, 125 mg delayed-release tablets for the symptomatic relief of non-infectious diarrhea in adult patients with HIV/AIDS, who are on anti-retroviral therapy or ART.
Fulyzaq is a locally-acting, minimally-absorbed drug derived from a botanical source. It is not available synthetically and Salix has the right to the manufacturing process for producing Fulyzaq from the biologic source.
Patents for Fulyzaq is expected to provide intellectual property protection to 2018. Fulyzaq is eligible for market exclusivity for five years as a new molecular entity in the U.S. and the product may be entitled to patent term restoration. The drug is expected to become accessible to patients in early 2013.
The drug is believed to act by blocking chloride secretion and thus reducing the accompanying high volume water loss as seen in HIV-associated diarrhea.
It is this secretion that is said to lead to diarrhea with the associated symptoms of dehydration, electrolyte imbalance, abdominal cramping, urgency and increased frequency.
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.
Data showed that a significantly larger proportion of patients taking Fulyzaq 125 mg twice daily experienced clinical response compared to patients in the placebo group. 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.
The Phase 3 study showed that Fulyzaq did not influence the efficacy or safety of the patients' HIV medications. The most common adverse reactions were respiratory tract infection, bronchitis, cough, flatulence and increased bilirubin.
SLXP closed at $40.47 on Monday.
by RTT Staff Writer
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