Relypsa Announces Phase 4 Study Shows Veltassa® Demonstrated Similar Efficacy and Safety Whether Given With or Without Food in Patients with Hyperkalemia
RELYPSA (RLYP)
US:NASDAQ Investor Relations:
relypsa.com/newsroom/investors
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Source: GlobeNewswire
REDWOOD CITY, Calif., Aug. 30, 2016 (GLOBE NEWSWIRE) -- Relypsa, Inc. (NASDAQ:RLYP), a biopharmaceutical company, today 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,
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