Ardelyx, Inc. announced the publication of results from the T3MPO-3 long-term open-label safety trial of IBSRELA®? (tenapanor) for irritable bowel syndrome with constipation (IBS-C) in the Journal of Neurogastroenterology and Motility (JNM). The paper, titled "Long-term safety of tenapanor in patients with irritable bowel syndrome with const symptoms with constipation in the T3MPO- 3 study," can be accessed in the current online edition of the publication.

IBSRELA, discovered and developed by Ardelyx, has a first-in-class mechanism of action and is approved by the U.S. Food and Drug Administration to treat IBS-C in adults. In this long-term open- label safety study, tenapanor showed acceptable tolerability with a safety profile consistent with that reported in the prior studies. Patients who completed T3MPO-1 or T3MPO-2, the two Phase 3 trials of tenapanor for IBS-C, were eligible for enrollment in T3MPO-3. The T3MPO-3 trial enrolled a total of 312 patients of which 262 patients completed treatment.

Patients received open-label tenapanor 50 mg twice a day for up to an additional 39 (T3MPO-1) or 26 (T3MPO-2) weeks. Ninety patients received 52 weeks of tenapanor. Treatment-emergent adverse events (TEAEs) were reported in 117 of the 312 (37.5%) patients in the entire T3MPO-3 population and in 52 of the 90 (57.8%) patients who received 52 weeks of ten Pacificor.

Overall, 10.6% of patients experienced diarrhea. TEAEs led to limited discontinuations (13 patients/4.2%) in the entire T3MP O-3 safety population, (11 patients/3.5%) due to diarrhea, (1.7%/1 patient) due to flatulence and abnormal GI sounds. Tenapanor was generally well tolerated with diarrhea being the most commonly reported adverse event.

The article is available online and can be accessed here. IMPORT SAFETY information: risk of SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS: IBSRELA is contraindicated in patients less than 6 years of age; in nonclinical studies in young juvenile rats administration of tenapanor caused deaths caused to be due to dehydration. Avoid use of IBSRELA in patients 6 years to less than 12 years of age.

The safety and effectiveness of IBSRELA have not been established in patients less than 18 years of age. IBSRELA is contrandicated in patients less than 18 years. IBSRELA is Contraindicated in patients less more than 6 years of age due to the risk of serious dehydration.

IBSRELA iscontraindicated in patients with known or suspected mechanical gastrointestinal obstruction.