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Ardelyx’s Ibsrela wins FDA approval for IBS-C

Published on 13/09/19 at 09:51am

Ardelyx announced that it has received FDA approval for its NHE3 sodium transport inhibitor Isbrela (tenapanor) for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults.

Isbrela is a 50mg, twice daily oral pill that is a minimally absorbed small molecule that acts locally in the gastrointestinal (GI) 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.

The approval comes on the back of data from its Phase 3 T3MPO-2 AND T3MPO-1 trials which both met their primary endpoints, assessing the proportion of patients who responded to treatment within a 12-week treatment period.

Those who responded were defined as patients who achieved reductions of at least 30%in weekly abdominal pain score compared to baseline, and an increase of one complete spontaneous bowel movement in weekly average for at least six of the first 12 treatment weeks.

Mike Raab, President and CEO for Ardelyx, said: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.

“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."

2015 saw Ardelyx agree to pay at least $25 million to leave a partnership with AstraZeneca, thereby regaining rights to its portfolio of NH3 inhibitors including Isbrela.

The company is also testing Isbrela for the treatment of hyperphosphatemia in end-stage renal disease patients on dialysis in a Phase 3 study called AMPLIFY which achieved positive results.

Ardelyx now plans to file the new drug application for hyperphosphatemia next year with a potential launch in 2021.

Nik Kiran

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