This past week, the U.S Food and Drug Administration (FDA) approved the sale and distribution of a new medication for irritable bowel syndrome with constipation (IBS-C), tenapanor, to be known by the brand name Ibsrela. Tenapanor, a 50 mg. daily oral medication is approved for adults. It has not been approved for youth under the age of 18 and at this time, is considered medically contraindicated for children under the age of 6.
Tenapanor is a minimally absorbed small molecule sodium-hydrogen exchanger NHE3 inhibitor, the first IBS medication that uses this mechanism. It was developed by Ardelyx, Inc. The current FDA approval is based on two recent studies. One showed that 37% of study volunteers met the criteria for response compared to 24% of those receiving a placebo. The second trial showed that 27% of those receiving tenapanor met the criteria for response compared to 19% of the placebo group. For both studies, a response was defined as at least a 30% reduction in weekly average abdominal pain and an increase of at least one complete, spontaneous bowel movement in the same week for at least 6 weeks.
The following links provide much of the information currently available. At this time, it is not clear when the medication will be available for prescription by doctors and sale to patients, but IBS Impact will attempt to update if significantly new details are released.
FDA approval and documents relating to tenapanor (Ibsrela)
“FDA approves Ibsrela for IBS-C in adults” from Healio Gastroenterology, a medical news site for health care professionals.
IBS Impact hopes that this medication will provide an effective new option for some individuals with IBS and urges readers to educate themselves thoroughly on the benefits and risks and to discuss with their physicians as to if it is appropriate for their own medical history and needs.
Posted September 2019