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Relypsa’s Veltassa shows consistent efficacy in phase 4 trial to treat hyperkalemia

PKBR Staff Writer Published 20 April 2017

Relypsa’s Veltassa (patiromer) has demonstrated consistent effficacy and safety in phase 4 Tourmaline study in patients with hyperkalemia.

The company presented topline results from the study of Veltassa for oral suspension on hyperkalemia when taken with or without food in patients with hyperkalemia.

Veltassa is a potassium binder, which secured approval to treat hyperkalemia, It will not be used as an emergency treatment for life-threatening hyperkalemia due to its delayed onset of action.

According to the company, the results demonstrated no statistically significant difference in the percentage of patients achieving serum potassium levels within the target range between the groups taking Veltassa with or without food at either week three or week four follow-up.

Among study participants taking Veltassa with food, around 87.3% achieved and maintained a potassium level in the target range, while 82.5% happened those taking Veltassa without food.

Results have been consistent when assessed by baseline potassium, race, eGF (an assessment of kidney function) and type 2 diabetes.

Tourmaline study randomly recruited 114 patients with blood potassium levels greater than 5.0 mEq/L to secure Veltassa once-a-day at a starting dose of 8.4 g either with or without food

Patients have been treated for four weeks and followed for two weeks after completing Veltassa treatment.

The trial’s primary endpoint include the comparison of the proportion of patients with blood potassium in the target range at week three or week four between the two treatment groups.

Tourmaline study primary investigator Dr Pablo Pergola said: “The results presented today are important because they demonstrate that Veltassa has a consistent potassium-lowering effect and safety profile whether taken with or without food.”

Relypsa medical and scientific affairs vice president Dr Alain Romero said: “As the Tourmaline study showed consistent efficacy and safety with Veltassa when taken with or without food in patients with hyperkalemia, we are preparing a supplemental New Drug Application based on these findings.”


Image: Relypsa has showed consistent effficacy and safety in phase 4 study in patients with hyperkalemia. Photo: courtesy of Relypsa Inc.