Ibsrela Approved to Treat Irritable Bowel Syndrome

September 12, 2019 – The U.S. FDA has approved Ibsrela® (tenapanor), manufactured by Ardelyx, to treat irritable bowel syndrome with constipation (IBS-C) in adults. A novel, minimally absorbed small molecule, Ibsrela acts locally in the gastrointestinal (GI) tract.

An estimated 15% of the U.S. population has irritable bowel syndrome (IBS), the most common condition diagnosed by gastroenterologists. It is a chronic condition characterized by recurring symptoms such as abdominal pain, altered bowel habits, constipation, and diarrhea. Patients who experience constipation more frequently than diarrhea are considered to have IBS-C. All forms of IBS can be extremely painful and disruptive to patients’ lives, causing them to miss work or school, and reducing their overall quality of life.

In clinical studies, a greater portion of patients who received Ibsrela showed a response than those who received a placebo. Response was defined as a 30% or more reduction in the weekly average abdominal pain score compared with baseline, and an increase of at least one complete spontaneous bowel movement by weekly average compared to baseline, both occurring in the same week, for at least six of the first 12 treatment weeks.

Recommended dosing is 50mg taken by mouth twice daily. The first dose should be taken immediately prior to the first meal of the day, while the second should be taken immediately before dinner. Ibsrela inhibits the NHE3, a protein that affects the balance of sodium in the body’s cells. Reducing the absorption of sodium in the GI tract increases water secretion, which helps increase bowel movements and decrease abdominal pain for IBS-C patients. A black box warning cautions that Ibsrela should not be used in children, as it can put them at serious risk of dehydration.

Ardelyx has not yet announced launch or pricing information.