IBS-D Lead May Go To Tioga With Salix Required To Run Another Trial
Irritable bowel syndrome is a promising, but challenging, U.S. market opportunity. On the one hand it offers a large patient population, which is only modestly served by two prescription therapies, but on the other, FDA sets a high safety bar for approving new IBS therapies because the condition is not seen as life-threatening.
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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.