Results from a new Phase 4 study demonstrated that Veltassa (patiromer for oral suspension; Relypsa) – a potassium binder that treats hyperkalemia – is just as effective when taken without food as it is with food.
Current administration of Veltassa oral suspension requires the treatment to be taken with food, as that is how it was administered in the original studies which supported the Food and Drug Administration’s approval in 2015.
The 4-week TOURMALINE study randomized 114 patients (with 112 who were eligible) with blood potassium levels greater than 5.0mEq/L to receive Veltassa once daily at a starting dose of 8.4g either with or without food. The primary endpoint was a comparison in both groups of the proportion of patients with blood potassium in the target range of 3.8 to 5.0mEq/L at week 3 or 4.
Results showed that 87.3% of the Veltassa plus food group and 82.5% of the Veltassa and no food group achieved and maintained potassium levels in the target range. Results were consistent when evaluated by baseline potassium, race, eGFR and type 2 diabetes.
Adverse event rates in the Veltassa plus food group was 48.2% and in the no food group was 42.1%; these rates were consistent with previous studies. “For patients with hyperkalemia, the ability to take Veltassa without food could provide greater flexibility in incorporating the medicine in their daily treatment regimen,” said Pablo Pergola, MD, PhD, lead investigator of the TOURMALINE study.
Last year the Food and Drug Administration approved a supplemental New Drug Application (sNDA) to remove a Boxed Warning regarding the separation of Veltassa and other oral medications. Now Relypsa is planning a new sNDA pertaining to the TOURMALINE results. Alain Romero, PhD, PharmD, and VP of Medical Affairs at Relypsa said, “We look forward to working with the FDA to revise the U.S. Veltassa label to reflect this important information.”
For more information visit Relypsa.com.