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Ardelyx's Ibsrela (tenapanor) Receives the US FDA's Approval for Irritable Bowel Syndrome with Constipation (ISB-C) for Adults

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Ardelyx's Ibsrela (tenapanor) Receives the US FDA's Approval for Irritable Bowel Syndrome with Constipation (ISB-C) for Adults

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  • The approval is based on P-III IBS-C program includes Trial 1 (NCT02686138) and Trial 2 (NCT02621892) which involve assessing of Ibsrela vs PBO in patients with abdominal pain and bowel movement frequency
  • The P-III IBS-C program met all 1EPs including Trial 1 and 2 (37%- 27% vs 24%- 19%)- discontinuation rates (7.6% vs 0.8%)
  • Ibsrela (50 mg- bid) is an orally administered drug involves inhibiting of sodium/hydrogen exchanger 3 (NHE3) targeted for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults

Click here to­ read full press release/ article | Ref: Ardelyx | Image: Twitter


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