Open-label safety data in patients with PSVT who had not received a test dose of CARDAMYST (n=503)¹

Within 24 hours of CARDAMYST use, 776 treatment-emergent adverse events were reported by 269 patients (53.5%). A total of 22 events in 16 patients (3.2%) were considered severe. No serious treatment-related adverse events were reported¹
In NODE-303, most treatment-emergent adverse events within 24 hours of CARDAMYST administration were localized to the nasal administration site (nasal discomfort, 30.2%; nasal congestion, 13.9%; rhinorrhea, 13.1%; epistaxis, 7.4%)¹

Conversion to sinus rhythm in patients with confirmed PSVT (n=312)¹

Chart showing conversion to sinus rhythm in patients with confirmed PSVT across 1 to 4 episodes.

All ECGs were validated to confirm PSVT as the presenting arrhythmia, with subsequent conversion to sinus rhythm that persisted for at least 30 seconds.¹

Across all episodes, the median times to conversion was 17.0 minutes¹
Among patients with at least 2 confirmed PSVT episodes (n=151), 71.5% (108/151) successfully converted to sinus rhythm with CARDAMYST by 60 minutes in the first episode. Of these, 80.6% (87/108) converted with CARDAMYST during their second episode¹
Even if the previous attempt was unsuccessful, over half (55.8%) of patients who didn’t convert in their first episode successfully converted on the second episode¹
Of patients who experienced a fourth PSVT episode, 94.4% (17/18) had converted to sinus rhythm within 60 minutes with CARDAMYST on at least 1 of their prior 3 episodes¹

Study Limitations¹:

NODE-303 was an open-label single-arm study
There was no formal statistical testing for efficacy endpoints. Data from the safety population were limited to summary descriptive statistics
Limitations of the recording device (eg, 2-lead configuration, recording quality) introduced the possibility of misclassifying some PSVT episodes as AV nodal-dependent when they were not
Conclusions regarding safety and efficacy cannot be made based on this data
This information is not included in the CARDAMYST Prescribing Information

NODE-303 Study Design¹

The NODE-303 study was a multi-center, open-label, single-arm phase 3 study that evaluated the safety and efficacy of CARDAMYST in adults with a history of symptomatic PSVT. NODE-303 had a “real-world” design, with no supervised test dose requirement and no exclusion of patients with a history of atrial fibrillation/flutter, and allowed up to 4 PSVT episodes to be treated.

PSVT treatment
Patients applied an ECG monitor at symptom onset and self‐administered a single dose of CARDAMYST if a vagal maneuver was unsuccessful. A repeat dose of CARDAMYST was administered if symptoms persisted 10 minutes after the first dose.

Patient populations 
The study enrolled 1116 patients, of whom 503 treated ≥1 perceived PSVT episode (safety population). Among 312 patients, 552 treated events were independently confirmed to be AV—nodal-dependent PSVT episodes with evaluable ECG data (efficacy population).

Key baseline patient characteristics from the safety population
Patients had a median age of 56 years (range, 19-88 years) and were 68% female. The majority of patients, 71%, were taking a concomitant beta blocker or calcium channel blocker.