Milestone Pharmaceuticals Inc. (Nasdaq: MIST) announced that the China National Medical Products Administration (NMPA) has approved CARDAMYST (Etripamil) nasal spray for the treatment of paroxysmal supraventricular tachycardia.
This is the first regulatory approval of Etripamil outside the United States, marking a significant milestone for the company’s global expansion strategy.
Understanding the Condition
Paroxysmal supraventricular tachycardia (PSVT) is a recurring heart rhythm disorder characterized by sudden episodes of rapid heartbeat that originate above the heart’s ventricles. These episodes can cause palpitations, dizziness, chest discomfort, and shortness of breath, often necessitating emergency medical care. Current therapeutic options are limited, with many patients depending on hospital‑based interventions to terminate attacks.
About Etripamil
Etripamil is a rapid‑acting calcium channel blocker delivered as a nasal spray. Designed for self‑administration at the onset of PSVT symptoms, it offers patients a convenient, non‑invasive method to manage their condition outside a clinical setting. Clinical trials have demonstrated that Etripamil can quickly restore normal heart rhythm, reducing the need for emergency care.
Regulatory Basis
The NMPA approval was supported by data from the global pivotal Phase 3 RAPID trial and the Phase 3 JX02002 study conducted in China. JX02002 met its primary endpoint, showing that Etripamil was markedly superior to placebo in converting PSVT to sinus rhythm within 30 minutes of dosing (hazard ratio = 3.002 [95% CI: 1.578, 5.711]; p = 0.0005). Treatment‑emergent adverse events were similar between the Etripamil and placebo groups, and no serious adverse events were reported within 24 hours after dosing across the Phase 3 program.
Commercial Partnership
Everest Medicines holds an exclusive license from Milestone to develop and commercialize Etripamil nasal spray in Greater China. Under the terms of the agreement, Milestone may receive up to $98 million in development and commercial milestones, plus tiered royalties of up to 18 % on future net sales of the product in the region.
Next Steps
Milestone indicated that the NMPA approval clears the path for commercial launch in China, where PSVT affects hundreds of thousands of patients. The company is also pursuing regulatory discussions in the United States and Europe, with the goal of expanding global access to Etripamil. CEO Joseph Oliveto noted that this approval underscores Etripamil’s potential to transform the PSVT treatment landscape by providing patients with an at‑home therapeutic option.
MIST has traded between $1.00 and $3.06 over the past year. The stock is currently trading at $1.23, up 5%.
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