Relypsa (RLYP) Announces Veltassa Phase 4 Met Primary Endpoint in Hyperkalemia
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Relypsa, Inc. (Nasdaq: RLYP) announced that the Phase 4 TOURMALINE study, which compared the efficacy and safety of Veltassa® (patiromer) for oral suspension given with or without food for the treatment of hyperkalemia, met its primary endpoint. Results showed no statistically significant difference in the percent of patients achieving either week 3 or week 4 serum potassium in the target range (3.8 - 5.0 mEq/L) between the group taking Veltassa with food and that taking it without. Adverse events with Veltassa in this study were consistent with previous clinical trials. Data from the TOURMALINE study will be submitted for presentation at a future medical meeting and shared with the U.S. Food and Drug Administration (FDA).
“In clinical studies supporting its approval, Veltassa was administered with food and its prescribing information requires Veltassa be taken with food,” said Lance Berman, M.D., chief medical officer of Relypsa. “We’re pleased that this study showed a similar efficacy and safety profile whether Veltassa was taken with or without food and will discuss these results with the FDA.”
About TOURMALINEPrevious clinical studies of Veltassa evaluated its safety and efficacy when taken with food. The TOURMALINE study was designed to compare the safety and efficacy of Veltassa when taken with or without food.
The TOURMALINE study evaluated 114 patients in the United States with blood potassium levels ≥5.1 to <6.5 mEq/L. Patients in the study were randomly assigned to receive Veltassa once-a-day at a starting dose of 8.4 g/day, either with or without food. Patients were treated for four weeks and followed for two weeks after completing Veltassa treatment. The primary endpoint was a comparison of the proportion of patients with either week 3 or week 4 serum potassium in the target range (3.8 - 5.0 mEq/L).
Approximately 3 million people in the United States with stage 3 or 4 chronic kidney disease (CKD) and/or heart failure have hyperkalemia, or elevated blood potassium levels. Hyperkalemia can cause abnormal heart rhythms and even sudden death. There are often no warning signs, meaning a person can unknowingly experience spikes in potassium levels recurrently and be at risk for these cardiac events. Some medicines that are often prescribed to people with CKD and heart failure to help delay progression of their underlying disease can cause hyperkalemia as a side effect. These include renin angiotensin aldosterone system (RAAS) inhibitors such as angiotensin receptor blockers (ARBs), aldosterone antagonists (AAs) and angiotensin-converting-enzyme (ACE) inhibitors.
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