Long-term data from NODE-302 suggests self-administered etripamil nasal spray for rapid heartbeat during PSVT well-tolerated and effective.
Long-term follow-up data from a phase 3 trial examining etripamil nasal spray suggests self-administration of the intranasal L- type calcium channel blocker during paroxysmal supraventricular tachycardia (PSVT) was well tolerated as a self-treatment for recurrent episodes of PSVT without medical supervision.
An open-label extension trial including patients from the phase 3 NODE-301 trial named the NODE-302 study, results suggest users had a 60.2% probability of conversion within 30 minutes of administration, with a median time to conversion of less than 16 minutes.1
“This is a potential new and exciting option for patients to safely self-treat their rapid heartbeat without direct medical supervision to avoid emergency room visits and medical interventions,” said lead investigator James E. Ip, MD, an associate professor of clinical medicine at Weill Cornell Medicine at New York-Presbyterian Hospital.2
Occurring in around 1 in every 300 adults, PSVT represents a common, but often overlooked form of arrhythmia. characterized by the sudden onset of a rapid regular rhythm with rates between 150 and 250 beats per minute, resolution of PSVT represents a challenge for many patients.3,4
An investigational fast-acting, nondihydropyridine, L-type calcium channel blocker, designed for unsupervised self-administration, etripamil nasal spray was developed by Milestone Pharmaceuticals for the management of PSVT without medical supervision. In recent years, the medical community has been the recipient of results from multiple trials examining the agent, including the phase 3 NODE-301 trial.
A double-blind, placebo controlled trial, NODE-301 enrolled 419 patients who underwent randomization in a 2:1 ratio to etripamil 70 mg or placebo. Per trial protocol, when PSVT symptoms developed, patients applied a cardiac monitor and attempted a vagal maneuver. If symptoms persisted, they self-administered blinded treatment.5
Published in Circulation: Arrhythmia and Electrophysiology in November 2022, results of the phase 3 trial indicated it had missed its primary 5-hour efficacy endpoint, but suggested etripamil nasal spray was effective at terminating PSVT at earlier timepoints. Of the 419 patients who were randomized to etripamil or placebo, 198 developed symptoms perceived by the patient to be due to PSVT that did not terminate with a vagal maneuver and administered the randomized intervention.5
From this group, 169 patients rolled in the NODE-302 open-label follow-up. Patients were considered eligible for inclusion in NODE-302 if they continued to meet the NODE-301 inclusion criteria and lacked exclusion criteria. Overall, the study cohort had a mean age of 58 years, 62% were women, and 83% were non-Hispanic White.1
In total, 105 of the 169 patients self-administered etripamil at least 1 time for perceived PSVT.Upon analysis, results indicated the probability of conversion within 30 minutes of etripamil administration was 60.2% among 188 positively adjudicated cases of PSVT, with a median time to conversion of 15.5 minutes. Analysis of a subgroup of patients who self-treated 2 episodes suggested 30 experienced a significantly consistent response by 30 minutes, 9 did not convert on either episode, and 21 converted on both episodes (X2= 8.09; P = .0045).1
When assessing the safety profile, investigators found 42.9% of the 105 patients who self-administered etripamil at least 1 time for perceived PSVT experienced at least 1 treatment-emergent adverse event. Investigators pointed out adverse events were generally transient and mild‐to‐moderate, with the most common being nasal congestion (14.3%), nasal discomfort (14.3%), or rhinorrhea (12.4%). Investigators also pointed out there were no serious cardiac safety events observed within 24 hours of etripamil administration.1
In a release from the American Heart Association, the organization noted etripamil nasal spray is being examined in a separate study starting this year among a patient population of children aged 6-17 years with PSVT. The release also pointed out plans to investigate etripamil for slowing the heart rate in patients with atrial fibrillation.1
”There are no great options for patients to self-treat paroxysmal supraventricular tachycardia, and this condition can cause significant distress and anxiety,” Ip added.2 “Similar to an albuterol inhaler for asthma patients or an epinephrine pen for patients that have severe allergies or anaphylaxis, etripamil nasal spray may be a great option for people who have paroxysmal supraventricular tachycardia.”