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.
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.