Data On Length Of Symptom Relief Could Improve Xifaxan Trial, Panel Members Suggest
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Viberzi and Xifaxan share an indication and an approval date, but not much else.
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.
Agency’s final guidance on clinical evaluation of irritable bowel syndrome drugs says sponsors should assess benefits of maintenance therapy and repeated courses of treatment in addition to short-term efficacy. The recommendations on clinical endpoints are “provisional” pending development of new patient-reported outcome measures.