FDA Approves First Self-Administered Nasal Spray for Rapid Heartbeat Disorder
Meta Description: Teh FDA has approved Cardamyst (etripamil) nasal spray, a groundbreaking self-administered treatment for paroxysmal supraventricular tachycardia (PSVT), offering a new option for managing rapid heart rate.
The Food and Drug Administration has approved intranasal etripamil, marketed as Cardamyst by milestone Pharmaceuticals, for the acute treatment of paroxysmal supraventricular tachycardia (PSVT).This marks a significant advancement in cardiac care, as it is the first self-administered, on-demand therapy designed to treat episodes outside of a customary healthcare setting. PSVT is characterized by sudden episodes of a rapid heartbeat – often exceeding 100 beats per minute – that can manifest as palpitations, chest discomfort, shortness of breath, dizziness, or even fainting.
while a single PSVT episode is typically not life-threatening, frequent or prolonged occurrences can contribute to more serious cardiac complications, including dilated cardiomyopathy. Prior to this approval, treatment options for PSVT were largely confined to interventions administered by healthcare professionals, such as diltiazem.
The RAPID trial enrolled 692 adults with a documented history of sustained, symptomatic PSVT. Participants were randomly assigned to receive either etripamil or a placebo, self-administering one dose at the first sign of symptoms and a second dose 10 minutes later if symptoms persisted. The primary goal of the trial was to measure the time it took to convert PSVT to a normal heart rhythm – sustained for at least 30 seconds – within 30 minutes of the initial dose, as determined by continuous electrocardiographic (EKG) monitoring.
Among patients with confirmed atrioventricular-nodal-dependent PSVT, a remarkable 64% of those treated with etripamil achieved a normal heart rhythm within 30 minutes, compared to just 31% in the placebo group (HR, 2.62; 95% CI, 1.66-4.15; P < .0001). The median time to conversion was significantly reduced with etripamil, at 17.2 minutes, versus 53.5 minutes with the placebo.
Beyond restoring a normal heart rhythm, secondary analyses revealed considerable improvements in patient-reported symptoms among those receiving etripamil. Compared to the placebo group, a significantly higher proportion of patients reported relief from rapid pulse, palpitations, shortness of breath, anxiety, and dizziness or lightheadedness. While improvements in tightness, pain, and pressure in the chest were observed, they were not statistically significant. Notably, fewer patients in the etripamil group required additional medical interventions, such as intravenous antiarrhythmics.
“RAPID was not powered to detect significantly different rates between treatment groups regarding additional medical interventions and emergency department visits,” the RAPID researchers explained. “Future studies will therefore be needed to confirm the potential of etripamil to decrease health-care burdens and costs.”
Etripamil Nasal Spray: Safety and Considerations
Safety findings from the RAPID trial were consistent with previous studies of intranasal etripamil. Treatment-emergent adverse events (AEs) occurred in 50% of patients receiving etripamil, compared to 11% of those receiving the placebo.The majority of these events were localized to the nasal administration site and were generally mild to moderate in severity. Common AEs included nasal discomfort (23%), nasal congestion (13%), rhinorrhea (9%), and epistaxis (6%). Importantly, no serious etripamil-related AEs or deaths were reported, and no instances of high-grade atrioventricular block or clinically significant bradyarrhythmias were observed on EKGs.
The FDA advises that patients with a hypersensitivity to etripamil or its components, those with heart failure, and individuals with certain underlying cardiac conditions should not use the drug.Due to the potential for dizziness or fainting, patients are instructed to administer the medication while seated.
This approval represents a paradigm shift in the management of PSVT, offering a convenient and effective self-treatment option for those experiencing this frequently enough-debilitating condition.
