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FDA has approved intranasal etripamil for paroxysmal supraventricular tachycardia, delivering fast, on-demand restoration of normal heart rhythm.
On 15 December 2025, the Food and Drug Administration (FDA) authorized etripamil nasal spray to relieve episodes of paroxysmal supraventricular tachycardia (PSVT), a condition in which the heart beats at an unusually rapid rate. PSVT episodes involve heart rates above 100 beats per minute and may cause palpitations, chest discomfort, shortness of breath, dizziness, lightheadedness, or fainting (syncope).
The condition arises when a short-circuit rhythm develops in the upper chambers of the heart and continues until normal rhythm is regained. In rare cases, frequent PSVT episodes may impair the heart and trigger dilated cardiomyopathy. Approval was supported by safety and effectiveness findings from the RAPID study, a randomized, double-blind, placebo-controlled phase 3 trial involving 692 patients. Volunteers were randomly assigned to receive etripamil nasal spray at a dose of 70 mg or placebo.
Patients experiencing a perceived PSVT episode self-administered one dose of the assigned treatment. A second dose was self-administered if the symptoms remained for 10 minutes after the first dose. The key endpoint was the time required for the abnormal heart rhythm to return to normal and remain normal for a minimum of 30 seconds. Etripamil nasal spray led to a higher proportion of patients achieving normal heart rhythm within 30 minutes compared to placebo, and it restored rhythm more rapidly overall (Table 1).
Common adverse effects noted were nasal discomfort, nasal congestion, runny nose, throat irritation, and nosebleeds.
U.S. FDA
FDA approves drug for type of abnormally fast heart rhythm
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