The approval was based on data from the Phase 4 TOURMALINE trial which randomized 114 patients with hyperkalemia to receive Veltassa once daily with food or without food for 4 weeks. Results showed that 87.3% of the Veltassa/food group and 82.5% of the Veltassa/no food group achieved potassium levels in the target range (3.8–5.0mEq/L) at either week 3 or week 4 (primary endpoint). Moreover, the results were consistent when baseline potassium, race, eGFR, and type 2 diabetes were considered; greater potassium reductions were observed in patients with higher baseline potassium levels. Adverse event rates were similar between both groups (48.2% with food vs 42.1% without food).
Veltassa, a sodium-free potassium binder, is approved for the treatment of hyperkalemia. It should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action.
Veltassa works by increasing fecal potassium excretion through binding of potassium in the lumen of the gastrointestinal (GI) tract; this reduces the concentration of free potassium in the GI lumen, resulting in a reduction of serum potassium levels.
Veltassa is supplied as a powder for oral suspension formulated with xanthan gum. The product is packaged in single-use packets containing 8.4g, 16.8g, or 25.2g patiromer.
For more information visit Veltassa.com.