Ardelyx (ARDX) announced that the company presented data supporting the company’s first-in-class retainagogue, IBSRELA, as well as results from the IBS in America 2024 supplemental survey, at the Digestive Disease Week Conference, DDW, now underway in San Diego. IBSRELA is approved by the U.S. Food and Drug Administration to treat irritable bowel syndrome with constipation, IBS-C, in adults. Poster # Mo1257, entitled “Patient-Reported IBS-C Symptom Severity Correlates Positively With Financial Burden: Results From the IBS in America 2024 Real-World Survey,” demonstrated that greater IBS-C symptom severity is associated with greater financial hardship and distress, or financial toxicity. Poster #Sa1643, entitled “Safety and Tolerability of Tenapanor in Pediatric Patients With Irritable Bowel Syndrome With Constipation: An Analysis of Blinded Safety Data from a Phase 3 Study and its Open-Label Extension,” reports interim, blinded safety results from the Phase 3 R-ALLY study of tenapanor in pediatric patients aged greater than or equal to12 to less than18 years-old with IBS-C, and its open-label safety extension study. Poster #Sa1673, entitled “Neither Tenapanor nor its Major Metabolite Were Detected in the Breast Milk of Healthy Lactating Females After 4 Days of Dosing: A Phase 1, Open-Label, Pharmacokinetic Study,” presents data from a four-day study that was conducted to assess the pharmacokinetics of tenapanor and its primary metabolite, M1, in breast milk, as well as the safety and tolerability of tenapanor in healthy lactating females.
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