FDA Approves Drug for Type of Abnormally Fast Heart Rhythm

https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218571s000lbl.pdf?utm_medium=email&utm_source=govdelivery The U.S. Food and Drug Administration (FDA) has approved Cardamyst (etripamil) nasal spray to treat episodes of paroxysmal supraventricular tachycardia (PSVT), a condition where the heart beats abnormally fast. Disease or Condition People with paroxysmal supraventricular tachycardia (PSVT) have episodes in which their heart beats very fast, over 100 beats per minute. Symptoms can include heart palpitations, chest discomfort, shortness of breath, dizziness or lightheadedness, and fainting. PSVT occurs when a short circuit rhythm develops in the heart’s upper chamber. Symptoms persist until the normal heart rhythm is restored. Rarely, PSVT can damage the heart if it occurs often, leading to dilated cardiomyopathy. Data Supporting Cardamyst The safety and efficacy of Cardamyst were evaluated in the RAPID study (NCT #03464019), a double-blind, placebo-controlled phase 3 study in which 692 patients were randomly assigned to receive Cardamyst 70 mg or a placebo. Patients with an episode of perceived PSVT self-administered one dose of the drug and self-administered a second dose if symptoms persisted 10 minutes after the first dose. The primary endpoint was time it took for the abnormal heart rhythm to return to normal and stay normal for at least 30 seconds. Results showed that 64% and 31% of patients receiving Cardamyst and placebo, respectively, returned to normal heart rhythms within 30 minutes. The median (midpoint) time it took to return to normal was approximately 17 minutes for patients taking Cardamyst compared with 54 minutes for patients taking the placebo. Safety Information The most common side effects with Cardamyst are nasal discomfort, nasal congestion, runny nose, throat irritation, and nose bleeds. Patients with a hypersensitivity to Cardamyst or its components, heart failure, or certain other pre-conditions should not take Cardamyst. The medication may cause dizziness or fainting, so people should administer Cardamyst in a sitting position.