Post-Hoc Analysis of the OPTIMIZE Study Supporting XPHOZAH® (tenapanor) to be Presented at the National Kidney Foundation Spring Clinical Meetings

Core Insights - Ardelyx, Inc. announced a post-hoc analysis of the OPTIMIZE Study for XPHOZAH at the NKF Spring Clinical Meetings, highlighting the importance of understanding patient experiences and optimizing treatment adherence [1][4] - XPHOZAH is the first phosphate absorption inhibitor approved by the FDA for adults with chronic kidney disease on dialysis, providing a unique mechanism of action to reduce serum phosphorus levels [2][12] - The OPTIMIZE Study involved 330 patients and aimed to evaluate phosphorus management methods with XPHOZAH in both binder-naïve and binder-treated patients [3] Company Overview - Ardelyx is focused on developing innovative, first-in-class medicines to address significant unmet medical needs, with two commercial products, IBSRELA and XPHOZAH, approved in the U.S. [13] - The company is also engaged in international collaborations for the commercialization of tenapanor, including agreements with Kyowa Kirin in Japan and Fosun Pharma in China [13] Product Details - XPHOZAH (tenapanor) is administered as a single tablet taken twice daily and works by inhibiting the sodium hydrogen exchanger 3 (NHE3) to reduce phosphate absorption [7][12] - Diarrhea is the most common side effect, reported in 43-53% of patients, with severe cases occurring in 5% of treated patients [11] Clinical Insights - The analysis presented at the NKF Spring Clinical Meetings indicated that among patients experiencing diarrhea, those using the anti-diarrheal medication loperamide had a lower discontinuation rate of 9.7% compared to 24.6% for those not using it [4] - The poster presentation titled "Tenapanor-Treated Patients Using Over-the-Counter Antidiarrheal Agents Saw Decreased Stool Frequency and Improved Stool Consistency" provided insights into managing diarrhea associated with tenapanor treatment [4][5] Industry Context - Hyperphosphatemia is a prevalent condition among the 550,000 patients in the U.S. with chronic kidney disease on dialysis, necessitating effective management strategies [8] - Current treatment guidelines recommend lowering elevated phosphate levels to the normal range of 2.5-4.5 mg/dL [9]