Dec. 1, 2021
Here is the link.
"IBSRELA, with its first-in-class mechanism and strong clinical data package, is an important new addition to the IBS-C treatment armamentarium," said Laura A. Williams, M.D., M.P.H., chief medical officer of Ardelyx. "The approval of IBSRELA was based on two successful Phase 3 trials involving over 1,200 patients with IBS-C. Both trials met their primary and most secondary endpoints. Additionally, in both trials, improvements from baseline in average weekly bowel movements and abdominal pain were observed by Week 1, with improvement sustained through the end of treatment. IBSRELA can play a meaningful role in the treatment of patients suffering from IBS-C."
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