Ardelyx's Ibsrela (tenapanor) Receives the US FDA's Approval for Irritable Bowel Syndrome with Constipation (ISB-C) for Adults
Shots:
- 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
This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com