Ardelyx Submits New Drug Application for U.S. Marketing Authorization of Tenapanor for IBS-C to U.S. Food and Drug Administration
FREMONT, Calif., Sept. 13, 2018 /PRNewswire/ -- Ardelyx Inc. (Nasdaq: ARDX), today announced the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) requesting U.S. marketing authorization of 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.
"This NDA submission represents an important advancement in the treatment of people with IBS-C," said William Chey, M.D., professor gastroenterology and nutrition at the University of Michigan and an investigator in Ardelyx's IBS-C clinical trials. "Despite the high prevalence of this disorder and the extremely burdensome symptoms associated with it, there are limited treatment options available. Current FDA approved treatments work to alleviate constipation through the secretion of chloride in the GI tract, and improve symptoms in only some patients. If approved, tenapanor would be the first medication available that works by reducing sodium uptake from the gut. The resulting increased fluid in the gut softens stools and improves bowel regularity. In addition, in clinical trials, tenapanor has demonstrated a statistically significant reduction in pain associated with IBS-C, a critical and difficult-to-manage symptom for these patients. In preclinical work, Ardelyx found that this reduction in pain is associated with the inhibition of TRPV-1 dependent signaling, which is unique from other current IBS-C therapies. I believe tenapanor has the potential to be an important new treatment and look forward to the potential opportunity to use it with my patients in the future."
"We are excited to have submitted our first NDA, which is the culmination of eight years of work by our team and a commitment from patients and our investigators, to whom we are very thankful," said Mike Raab, president and chief executive officer of Ardelyx. "Tenapanor has demonstrated clear efficacy and tolerability in our Phase 3 clinical program. With its novel mechanism of action, we believe it could make a significant difference in the lives of patients who struggle with the symptoms of IBS-C and provide physicians a new option for treating their patients. If accepted, our partners, Knight Therapeutics and Fosun Pharma will be able to leverage our NDA, bringing them closer to filing in their territories and launching tenapanor for IBS-C in Canada and China. We will continue to evaluate additional collaborations to bring tenapanor to patients and physicians in the United States and around the world who need another treatment option."
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 3 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.
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Company Codes: NASDAQ-NMS:ARDX