According to Milestone Pharmaceuticals, a Phase 3 trial of etripamil nasal spray in patients with paroxysmal supraventricular tachycardia (PSVT) that was conducted by Ji Xing Pharmaceuticals in China met its primary endpoint of the proportion of patients converting to sinus rhythm within 30 minutes post-dose. Ji Xing acquired the Chinese rights to etripamil for PVST in 2021.
Milestone said that the design of the Chinese study was basically the same as the RAPID Phase 3 study of etripamil that met its primary endpoint in 2022. The study enrolled 500 patients who self-administered etripamil or a placebo nasal spray while experiencing an episode of PVST.
Milestone President and CEO Joseph Oliveto commented, “Congratulations to Ji Xing and all the clinical investigators on the successful completion of this large Phase 3 study of etripamil in PSVT. We are proud to partner with our colleagues at Ji Xing as they advance etripamil toward regulatory approval in China, with the potential to help millions of patients struggling with PSVT.”
In the US, Milestone resubmitted its NDA for Cardamyst etripamil for the treatment of PSVT in March 2024, and the FDA accepted the submission in May 2024. The company is also developing etripamil for the treatment of atrial fibrillation with rapid ventricular rate (AFib-RVR).
Read the Milestone Pharmaceuticals press release.
