FDA Approves New Treatment for IBS-C

The US Food and Drug Administration (FDA) has approved tenapanor (Ibsrela)—a 50 mg, twice daily oral pill—for the treatment of individuals with constipation-predominant irritable bowel syndrome (IBS-C), according to a press release issued by its manufacturer, Ardelyx.

The approval comes after findings from 2 clinical trials showed that participants who received treatment with tenapanor had a reduced abdominal pain score of at least 30% compared with baseline, as well as an increase of at least 1 complete spontaneous bowel movements in weekly average from baseline, in the same week, for a minimum 6 weeks of the first 12 weeks of treatment.

In both clinical trials, the most common adverse reaction was diarrhea; severe diarrhea was reported in 2.5% of participants who received treatment with tenapanor.

“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, president and chief executive officer of Ardelyx, said in the press release.

—Colleen Murphy

Reference:

Ardelyx receives FDA approval for IBSRELA® (Tenapanor), an NHE3 sodium transport inhibitor, for the treatment of irritable bowel syndrome with constipation [press release]. Fremont, CA: Ardelyx; September 12, 2019. http://ir.ardelyx.com/news-releases/news-release-details/ardelyx-receives-fda-approval-ibsrelar-tenapanor-nhe3-sodium. Accessed September 13, 2019.