Long-term safety of tenapanor in people with irritable bowel syndrome with constipation from the T3MPO-3 study: plain language summary of publication

Abstract

Summary This document provides a short summary of the T3MPO-3 study, which was published in Neurogastroenterology and Motility in September 2023. At the end of this summary, there are links to websites where you can find more information about this study. Tenapanor (IBSRELA®) is a newly available medicine in the United States. It is used to treat irritable bowel syndrome with constipation (IBS-C) in people aged 18 years and older. In 2 large clinical trials, tenapanor was shown to improve the symptoms of IBS-C. People with IBS-C often need to take long-term medicines to keep their symptoms under control. As a result, this study, called T3MPO-3 , was undertaken to investigate whether there are any possible side effects associated with the long-term use of tenapanor in adults with IBS-C. There were 312 people who had taken part in either of the original 2 trials and took part in this study, with 90 receiving tenapanor for at least 1 year. Loose or watery stool (diarrhea) was the most common side effect, and most cases were mild or moderate. No people died in any of these studies. Who is this article for? This summary may help people with irritable bowel syndrome with constipation (IBS-C) and their family members and/or caregivers better understand the long-term safety of tenapanor for treating IBS-C. Two IBS-C patient advocates coauthored this summary. Where is the T3MPO-3 study in the medicine development timeline? The T3MPO-3 study was completed in 2018. In 2019, the Food and Drug Administration (FDA) approved tenapanor in the United States to treat IBS-C in adults. • The FDA is responsible for public health in the United States and makes sure that medicines are safe and effective. The medicine development process starts with laboratory and animal testing. Once a potential medicine has been identified and proven to be safe and effective in animals, it is tested in humans in phase I, phase II, and phase III studies. T3MPO-3 was a phase III study. What were the overall results? Diarrhea was the most common side effect in the three T3MPO studies. A side effect is something (expected or unexpected) that you feel was caused by a medicine or treatment you take. Side effects were similar to those reported by researchers in previous studies. No new safety issues were found with long-term use of tenapanor .