The New Drug Application (NDA) for tenapanor (Ardelyx), an investigational treatment for irritable bowel syndrome with constipation (IBS-C), has been submitted to the Food and Drug Administration.
Tenapanor, a minimally-systemic small molecule, inhibits the sodium transporter NHE3 and reduces sodium absorption in the gastrointestinal tract, thus increasing intestinal fluid. The NDA includes data from two Phase 3 trials (T3MPO-1 and T3MPO-2) and 1 long-term safety extension trial (T3MPO-3). Both of the efficacy trials demonstrated that tenapanor had a durable effect on reducing constipation and abdominal pain in patients with IBS-C. In addition, a favorable safety profile was noted in all trials.
“If approved, tenapanor would be the first medication available that works by reducing sodium uptake from the gut,” said William Chey, MD, professor gastroenterology and nutrition at the University of Michigan and an investigator in Ardelyx’s IBS-C clinical trials. “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.”
Ardelyx estimates that they will receive notification of acceptance of the NDA before the end of 2018.
For more information visit Ardelyx.com.