Drug Update · Cardiology

FDA Approves Etripamil for PSVT: 64% 30‑min Conversion in RAPID

August 11, 2026

FDA approval date

December 12, 2025

Primary efficacy (30 min conversion)

64% with etripamil vs 31% with placebo (HR 2.62; 95% CI 1.66-4.15) [1][12]

Median time to conversion

17.2 min (etripamil) vs 53.5 min (placebo) [1][12]

Approved dose

70 mg intranasal (one spray each nostril); repeat 70 mg if needed after 10 minutes; max 140 mg/24h [4][10]

Pivotal trial

RAPID (randomized, double-blind, placebo-controlled) [1][12]

Clinical Perspective

Clinicians who manage adult patients with acute symptomatic PSVT now have an FDA-approved intranasal, self-administered option for conversion to sinus rhythm that is intended for use outside a health-care setting ^[4]^[5]. The RAPID data support more rapid conversion to sinus rhythm compared with placebo, with 64% versus 31% conversion by 30 minutes and a shorter median time to conversion ^[1]^[5]. How etripamil will be incorporated alongside existing acute treatments and which subsets of patients will benefit most from at-home self-administration remain practical questions for clinicians as post-approval experience accumulates.

Dr. Arjun Sharma · Cardiology

The FDA approved etripamil (CARDAMYST) nasal spray for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults on December 12, 2025, based on the RAPID trial showing higher conversion rates to sinus rhythm by 30 minutes with etripamil versus placebo ^[4]^[5]. The approved regimen is a 70 mg intranasal dose (one spray in each nostril) with an optional second 70 mg dose if symptoms persist after 10 minutes (maximum 140 mg per 24 hours) ^[2]^[3]. Clinicians should consult current prescribing information for full dosing guidance.

Clinical Context

Etripamil is an L-type calcium channel blocker developed as a fast-acting intranasal agent for on-demand, out-of-clinic conversion of atrioventricular-nodal-dependent PSVT to sinus rhythm ^[1]^[3]^[5]. Milestone Pharmaceuticals USA, Inc. markets CARDAMYST in the United States; the product is supplied as a single-use nasal spray device delivering 70 mg per device (two metered sprays per device) ^[2]^[3]. Clinicians should consult current prescribing information for full dosing guidance. The regulatory submission and label describe use in adults with acute symptomatic PSVT and include instructions for intranasal administration and a repeat-dose option for persistent symptoms at 10 minutes ^[2]^[3]^[5]. RAPID provided the primary evidence supporting the approval ^[1]^[4]^[5].

Key Findings

The RAPID study showed CARDAMYST achieved conversion to sinus rhythm by 30 minutes in 64% versus 31% with placebo in patients with confirmed atrioventricular-nodal-dependent PSVT in an event-driven randomized trial (hazard ratio 2.62; 95% CI 1.66-4.15) ^[1]^[5].
In RAPID, median time to conversion was 17.2 minutes (95% CI 13.4-26.5) with the etripamil regimen versus 53.5 minutes (95% CI 38.7-87.3) with placebo ^[1]^[5].
Of 692 patients randomized in RAPID, 255 self-administered study drug for a perceived PSVT episode and 184 episodes (99 etripamil, 85 placebo) were adjudicated as atrioventricular-nodal-dependent PSVT for the primary analysis; these confirmed-event results were the basis for the efficacy assessment ^[1]^[5].

Safety & Tolerability

Treatment-emergent adverse events occurred in 68 (50%) of 99 patients treated with etripamil and 12 (11%) of 85 patients in the placebo group; most were located at the administration site, were mild or moderate, and were transient and resolved without intervention ^[1].
Nasal discomfort occurred in 23% of etripamil-treated patients in RAPID ^[1].
Nasal congestion occurred in 13% of etripamil-treated patients in RAPID ^[1].
Rhinorrhea occurred in 9% of etripamil-treated patients in RAPID ^[1].
Pooled randomized studies listed throat irritation and epistaxis among the most frequent adverse reactions with incidence ≥5% ^[2]^[3].
No serious etripamil-related adverse events or deaths were reported in RAPID ^[1].

Study Design

The pivotal RAPID study (NODE-301 part 2) was a multicentre, randomized, double-blind, placebo-controlled, event-driven trial in which patients with a history of symptomatic PSVT who tolerated intranasal test dosing were randomized 1:1 to etripamil or placebo; patients self-administered a first 70 mg intranasal dose prompted by symptoms and could self-administer a second 70 mg dose if symptoms persisted after 10 minutes ^[1]^[5]. Clinicians should consult current prescribing information for full dosing guidance. The primary endpoint was time to conversion to sinus rhythm for at least 30 seconds within 30 minutes after the first dose in adjudicated atrioventricular-nodal-dependent events; Kaplan-Meier conversion estimates by 30 minutes were 64% with etripamil and 31% with placebo, HR 2.62 (95% CI 1.66-4.15) ^[1]^[5]. The FDA approved CARDAMYST on December 12, 2025 ^[4]^[5].

FAQ

Q1 What is etripamil (CARDAMYST) approved for?

CARDAMYST (etripamil) nasal spray is approved to convert acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults. The FDA approval specifies intranasal administration for acute symptomatic episodes in adult patients.

Q2 How does etripamil work?

Etripamil is an L-type calcium influx inhibitor (a calcium channel blocker) that modulates calcium entry in AV nodal cells; by interrupting AV-nodal reentry, etripamil can restore sinus rhythm in patients with AV-nodal-dependent PSVT, as described in the product labeling and pharmacology sections of the prescribing information.

Q3 What is the recommended dose of CARDAMYST?

The approved initial dose is 70 mg administered intranasally as two sprays (one spray into each nostril) delivered by a single CARDAMYST device; if symptoms persist after 10 minutes a second 70 mg dose (one spray into each nostril using a second device) may be administered, not to exceed 140 mg in a 24-hour period.

Q4 What are the most common side effects of etripamil?

Across randomized controlled studies and in RAPID, the most commonly reported adverse reactions were local nasal and upper-airway events. In RAPID, treatment-emergent adverse events occurred in 50% of etripamil-treated patients versus 11% of placebo; common named events in RAPID included nasal discomfort (23%), nasal congestion (13%), and rhinorrhea (9%); pooled randomized studies also list throat irritation and epistaxis among adverse reactions with incidence ≥5%. Most adverse events were reported as mild or moderate, localized to the administration site, transient, and resolved without intervention; no etripamil-related deaths or serious adverse events were reported in RAPID.

Clinicians should consult current prescribing information for complete dosing guidance.

FDA Approves Etripamil for PSVT: 64% 30‑min Conversion in RAPID

Direct Clinical Takeaway & Evidence Summary

FDA Approves Etripamil for PSVT: 64% 30‑min Conversion in RAPID

Clinical Perspective

Clinical Context

Key Findings

Safety & Tolerability

Study Design

FAQ

References

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