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Salix responds to FDA regarding application for Xifaxan for IBS-D
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Salix Pharmaceuticals submitted its response to the FDA complete response letter concerning its supplemental new drug application for rifaximin, which proposed that the drug be indicated for diarrhea-predominant irritable bowel syndrome, according to a company press release.
In conjunction with the FDA, Salix developed the TARGET 3 study in response to the FDA’s original review of the company’s supplemental new drug application in March 2011. That review determined that data on Xifaxan’s ability to provide long-term retreatment benefits was needed, according to the release.
In July, Salix reported significantly greater repeat treatment response in 636 patients with irritable bowel syndrome with diarrhea (IBS-D) treated with rifaximin 550 mg compared with controls, the release said. The data from the phase 3 prospective, controlled study also indicated a good safety profile, including no microbiota disturbance compared with single-course patients, no cross-resistance to non-rifamycin antibiotics and no predisposition to pathogenic bacteria.
“We are pleased that the outcome of TARGET 3 provides both prospective controlled data to support the efficacy and safety of repeat treatment with rifaximin,” Bill Forbes, PharmD, executive vice president of medical, research and development, and chief development officer of Salix, said in the release. “Beyond corroborating the efficacy and safety results of TARGET 1 and TARGET 2, the results of TARGET 3 provide important microbiome as well as culture and susceptibility results that provide additional support of the safety of repeat treatment with rifaximin.”
The FDA will have 6 months to respond to Salix.