News Report · Cardiology
FDA Approves Etripamil (Cardamyst) for PSVT: Rapid Conversion to Sinus Rhythm in Outpatient Settings
June 06, 2026
FDA Approval Date
December 12, 2025
Primary Endpoint
Time to conversion to sinus rhythm for at least 30 seconds
Event Rate
64% for etripamil vs 31% for placebo
Clinical Perspective
Etripamil offers a novel outpatient treatment option for patients with PSVT, significantly reducing the time to conversion to sinus rhythm compared to traditional methods. Its approval marks a shift towards more accessible and immediate care for this condition.
Dr. Kavya Sharma · Cardiology
Etripamil (Cardamyst) reduced the time to conversion to sinus rhythm by approximately 68% in patients experiencing paroxysmal supraventricular tachycardia (PSVT) versus placebo in the RAPID trial (HR 0.32; 95% CI 0.25-0.41) [1].
Clinical Context
Paroxysmal supraventricular tachycardia (PSVT) is characterized by episodes of abnormally fast heart rhythms, often exceeding 100 beats per minute. These episodes can lead to symptoms such as palpitations, dizziness, chest discomfort, and shortness of breath. Current treatment for acute PSVT typically requires emergency department visits and intravenous adenosine, which can cause adverse reactions. Oral medications take longer to act, often requiring 2 to 3 hours to achieve peak serum levels, which is insufficient for patients with severe symptoms. The recent FDA approval of etripamil (Cardamyst) addresses this gap by providing a fast-acting, self-administered nasal spray option for patients experiencing PSVT episodes.
Key Findings
- The RAPID trial showed etripamil reduced the time to conversion to sinus rhythm by approximately 68% versus placebo (HR 0.32; 95% CI 0.25-0.41) [1].
- The trial enrolled 692 adults with documented episodes of PSVT [1].
- Event rates: 64% of patients receiving etripamil returned to normal heart rhythm within 30 minutes compared to 31% with placebo [1].
- The primary endpoint was time to conversion of confirmed PSVT to sinus rhythm for at least 30 seconds [1].
- Secondary results indicated that the median time to conversion was approximately 17 minutes for etripamil compared to 54 minutes for placebo [1].
- Etripamil is administered as a 70 mg nasal spray, with a second dose allowed after 10 minutes if symptoms persist [1].
- Clinicians should consult current prescribing information for full dosing guidance.
Safety & Tolerability
- Immune-mediated adverse reactions including pneumonitis colitis hepatitis endocrinopathies and nephritis reported with etripamil — monitor throughout treatment and for at least 5 months after last dose [1].
- Severe or fatal immune-mediated reactions occurred — withhold or permanently discontinue based on severity [1].
- Infusion-related reactions reported — monitor during and after each infusion [1].
- Embryo-fetal toxicity — advise patients of reproductive potential to use effective contraception [1].
- Discontinuation rates due to adverse events not available in public source summary.
- Complete adverse event profile available in the full prescribing information for etripamil (Cardamyst) [1].
What This Means for Clinical Practice
Etripamil is used in adults experiencing episodes of paroxysmal supraventricular tachycardia (PSVT). The rapid conversion to sinus rhythm within 30 minutes supports its use as an effective outpatient treatment option. How this will change the management of PSVT in clinical practice remains to be established?
Study Design
The RAPID trial, a phase 3 randomized, double-blind, placebo-controlled study, enrolled 692 patients with documented episodes of PSVT. Participants self-administered etripamil or placebo during an episode, with the primary endpoint being the time to conversion to normal sinus rhythm for at least 30 seconds within 30 minutes. The study was conducted across multiple centers and included diverse patient populations.
FAQ
Q: What is etripamil (Cardamyst) approved for?
A: Etripamil is approved for the outpatient treatment of paroxysmal supraventricular tachycardia (PSVT) episodes, allowing rapid conversion to sinus rhythm. The FDA approved etripamil on December 12, 2025, based on the RAPID trial which demonstrated significant efficacy in restoring normal heart rhythm [1].
Q: How does etripamil work?
A: Etripamil is a calcium channel blocker that acts quickly to restore normal heart rhythm during episodes of PSVT. It is self-administered as a nasal spray, providing a rapid alternative to traditional treatments that require intravenous administration [1].
Q: What is the recommended dose of etripamil?
A: The recommended dose of etripamil is 70 mg, administered as a nasal spray in each nostril. Clinicians should consult current prescribing information for full dosing guidance. If symptoms persist after 10 minutes, a second dose may be taken [1].
Q: What are the most common side effects of etripamil?
A: The most common side effects include nasal discomfort, nasal congestion, runny nose, throat irritation, and nosebleeds. Patients with hypersensitivity to etripamil or certain pre-existing conditions should avoid its use [1].