Ardelyx gets FDA green light for Ibsrela

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Ardelyx gets FDA green light for Ibsrela

By Sandra Levy - 09/13/2019
Ardelyx, a specialized biopharmaceutical company has the received Food and Drug Administration’s nod for Ibsrela (tenapanor), a 50-mg, twice-daily oral pill for the treatment of irritable bowel syndrome with constipation, or IBS-C, in adults.

Ibsrela is a minimally-absorbed small molecule that acts locally in the gastrointestinal tract to inhibit the sodium-hydrogen exchanger NHE3, resulting in an increase in bowel movements and a decrease in abdominal pain for IBS-C patients.

"Ibsrela has the potential to provide IBS-C patients and their doctors with a novel mechanism and an innovative approach to managing IBS-C, a highly burdensome and difficult-to-treat condition affecting more than 11 million people in the United States," Mike Raab, Ardelyx president and CEO said. "This approval is an extremely important and rewarding milestone for Ardelyx, and represents the culmination of years of dedication to advancing our discoveries and medicines in an effective and rigorous manner. We look forward to establishing a commercial collaboration with a partner that has the capabilities to drive the successful launch and marketing of Ibsrela in this large and underserved IBS-C patient population."