Panel To Help Define Target Population For Xifaxan Reuse In IBS-D
This article was originally published in The Pink Sheet Daily
FDA’s Gastrointestinal Drugs Advisory Committee Nov. 16 will review a trial design for evaluating the safety and efficacy of retreatment for the chronic condition with Silax’s antibiotic Xifaxan.
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With new retreatment data in hand, Salix is again pursuing a supplemental claim for the antibacterial Xifaxan, while Actavis is seeking approval of eluxadoline, a new molecular entity with dual opioid receptor activity.
Success in a single course of treatment is not enough to identify patients for long-term intermittent treatment with the antibiotic, the Gastrointestinal Drugs Advisory Committee tells FDA Nov. 16
On Nov. 16, FDA's outside advisors will discuss the design of clinical trials to evaluate the safety, efficacy and durability of response with repeat treatment cycles of rifaximin for diarrhea-predominant IBS.