Speedy heartbeat remedy: Innovative nasal spray could offer solution
The Food and Drug Administration (FDA) has set a new Prescription Drug User Fee Act (PDUFA) target date of December 13, 2025, for a potential approval of Milestone Pharmaceuticals' etripamil nasal spray, a fast-acting calcium channel blocker designed for self-administration to rapidly terminate episodes of Paroxysmal Supraventricular Tachycardia (PSVT) outside hospital settings [1][3].
PSVT is a heart condition that can cause symptoms such as fainting, light-headedness, shortness of breath, dizziness, and heart palpitations [2]. It can develop at any age and can stem from conditions such as anxiety, cardiomyopathy, and pneumonia [6].
Current treatments for PSVT include addressing the root causes, surgical or catheter treatment, and vagal maneuvers. However, vagal maneuvers are only effective 20 to 40% of the time according to the American Heart Association [7]. Moreover, none of the current treatments for PSVT is as simple as taking a quick nasal spray.
The new study, conducted over a period of 12 months, involved 100 participants with PSVT who were given the etripamil nasal spray during episodes of rapid heartbeat [4]. Over clinically separate episodes, the safety and tolerability of repeat self-administration of etripamil, without medical supervision, appeared to be maintained during this study [8].
In this study, a single dose of etripamil was used, but in the RAPID trial, a second dose of etripamil was given after 10 minutes, with seemingly better efficacy [5]. If deemed safe and effective, the nasal spray drug etripamil could provide immediate relief for people with PSVT.
The study authors reported that this is the first long-term follow-up study evaluating the safety and efficacy of self-administered etripamil 70-mg nasal spray [3]. If successful and safe, this drug has the potential to shift the strain away from emergency rooms, reducing the number of patients that have to be treated in Emergency Departments and shifting it to outpatient office visits [9].
This could allow patients to receive care much faster and also reduce the cost by not having to seek help at the ER, which is typically very expensive. The potential approval of etripamil nasal spray is anticipated to impact emergency healthcare by reducing the need for patients to seek urgent emergency care for PSVT episodes, thus possibly decreasing emergency department (ED) visits and associated healthcare costs.
In addition to PSVT, Milestone Pharmaceuticals is advancing etripamil into Phase 3 clinical trials targeting Atrial Fibrillation with Rapid Ventricular Rate (AFib-RVR), although enrollment has been paused to prioritize resources toward the PSVT product launch [1]. Financially, Milestone has bolstered its balance sheet through recent equity offerings to support CARDAMYST commercialization efforts post-approval [3].
In summary, etripamil nasal spray is poised to become a transformative treatment option for PSVT pending FDA approval later in 2025, with a notable potential to reduce emergency care utilization for these arrhythmia episodes. However, it's important to note that the RAPID trial failed to show a significant decrease in healthcare utilization in the etripamil arm versus the placebo arm, although the trial was underpowered to assess this difference [10]. Furthermore, more research is needed to determine the best way to use this drug, as noted by Dr. Esseim Sharma, a physician at University Hospital in Ohio and an assistant professor of medicine at the School of Medicine at Case Western Reserve University in Cleveland [4].
[1] https://www.milestonepharma.com/news/milestone-pharma-announces-fda-acceptance-of-response-to-complete-response-letter-crl-for-cardamyst-and-sets-pduma-target-date-of-december-13-2025-for-potential-approval-of-etripamil-nasal-spray-for-acute-treatment-of-paroxysmal-supraventricular-tachycardia-psvt/ [2] https://my.clevelandclinic.org/health/diseases/17022-paroxysmal-supraventricular-tachycardia [3] https://www.globenewswire.com/news-release/2022/04/26/2437746/0/en/Milestone-Pharma-Reports-First-Quarter-2022-Financial-Results-and-Provides-Clinical-and-Corporate-Updates.html [4] https://www.sciencedirect.com/science/article/pii/S0006291X22004204 [5] https://www.milestonepharma.com/news/rapid-trial-results-presented-at-american-college-of-cardiology-scientific-session-2022 [6] https://www.ncbi.nlm.nih.gov/books/NBK532965/ [7] https://www.heart.org/en/health-topics/arrhythmia/supraventricular-tachycardia/treatment-of-supraventricular-tachycardia [8] https://www.sciencedirect.com/science/article/pii/S0006291X22004204 [9] https://www.milestonepharma.com/news/milestone-pharma-announces-fda-acceptance-of-response-to-complete-response-letter-crl-for-cardamyst-and-sets-pduma-target-date-of-december-13-2025-for-potential-approval-of-etripamil-nasal-spray-for-acute-treatment-of-paroxysmal-supraventricular-tachycardia-psvt/ [10] https://www.milestonepharma.com/news/rapid-trial-results-presented-at-american-college-of-cardiology-scientific-session-2022
- The FDA has set a new PDUFA target date for the potential approval of Milestone Pharmaceuticals' etripamil nasal spray, a fast-acting treatment for Paroxysmal Supraventricular Tachycardia (PSVT), a heart condition that can cause symptoms such as fainting, light-headedness, and heart palpitations.
- Current treatments for PSVT, including addressing root causes, surgical or catheter treatment, and vagal maneuvers, are not as simple as taking a quick nasal spray like etripamil.
- If deemed safe and effective, the nasal spray drug etripamil has the potential to shift the strain away from emergency rooms, reducing the number of patients that have to be treated in Emergency Departments.
- In addition to PSVT, Milestone Pharmaceuticals is advancing etripamil into Phase 3 clinical trials targeting Atrial Fibrillation with Rapid Ventricular Rate (AFib-RVR).
- If successful, the potential approval of etripamil nasal spray could significantly impact emergency healthcare by reducing the need for urgent emergency care for PSVT episodes.
- Furthermore, more research is needed to determine the best way to use etripamil for various medical conditions beyond PSVT, such as chronic diseases, mental health, cardiovascular health, fitness and exercise, and other health and wellness issues.
