RDX 5791 filed with FDA for irritable bowel syndrome with constipation.- Ardelyx.

Ardelyx announced the submission of its New Drug Application (NDA) to the FDA requesting U.S. marketing authorization of RDX 5791 (tenapanor) for the treatment of patients with irritable bowel syndrome with constipation (IBS-C). Tenapanor, Ardelyx's lead product candidate, is a minimally-systemic small molecule that acts locally in the gastrointestinal (GI) tract to inhibit the sodium transporter NHE3 and reduce sodium uptake from the gut.

Ardelyx's NDA submission is supported by a clinical package encompassing more than 3,100 patients and healthy volunteers who have participated in Ardelyx trials and an extensive clinical and preclinical data package supporting the excellent safety profile. The data include results from the completed IBS-C registration T3MPO program, which consisted of two Phase III trials, T3MPO-1 and T3MPO-2, and a long-term safety extension trial, T3MPO-3. Both the T3MPO-1 and T3MPO-2 trials achieved statistical significance for their primary endpoint and demonstrated that tenapanor had a durable effect on reducing constipation and abdominal pain that patients with IBS-C experience. The favorable safety profile of tenapanor, which has been shown across all trials, was further supported by the completed T3MPO-3 study. Based on standard FDA review timelines, Ardelyx expects to receive notification of acceptance of the filing for substantive review before the end of the year.