Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Etripamil · 4 trials · 3 indications
The maximum reduction in ventricular rate, measured from ECG CMS recordings, within 30 minutes from first drug administration
Baseline ventricular rate is defined as the average heart rate over 5 minutes immediately prior to drug administration. Nadir is defined as the lowest moving average heart rate over 5 minutes recorded in the 60 minutes post drug administration.
The primary efficacy endpoint was the rate of successful PSVT conversion to sinus rhythm lasting at least 30 seconds within 15 minutes of study drug administration after a minimum of 5 minutes in sustained PSVT.
To measure Cmax of Etripamil after single dosing
To measure Cmax of MSP-2030 after single dosing
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Patients will self-administer an initial dose of placebo for a perceived episode of AF with RVR, followed by an optional second dose 10 minutes later if symptoms persist. |
| Etripamil | EXPERIMENTAL | Patients will self-administer an initial dose of etripamil for a perceived episode of AF with RVR, followed by an optional second dose 10 minutes later if symptoms persist. |
| Etripamil Nasal Spray 70mg | EXPERIMENTAL | Etripamil Nasal Spray 70mg single dose |
| Etripamil Placebo Nasal Spray 70mg | PLACEBO_COMPARATOR | Etripamil Placebo Nasal Spray 70mg single dose |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | The formulation of placebo will consist of water, sodium acetate, disodium EDTA, and sulfuric acid to reproduce the same pH as the etripamil formulation. |
| Etripamil | DRUG | The formulation of etripamil is for IN administration and will consist of etripamil, water, acetic acid, disodium ethylene-diamine-tetra-acetic acid (EDTA), and sulfuric acid. The dose of etripamil to be evaluated in this study is 70 mg with an optional second dose of 70 mg 10 minutes after the first dose if symptoms persist. |
| Etripamil Nasal Spray 70mg | DRUG | Etripamil NS 70 mg will be administered via the Aptar Pharma Nasal Spray Bidose System, supplied as prefilled devices packaged into child-resistant boxes with instructions for use provided in the study drug box. |
Inclusion Criteria: 1. Age 18 years and over. 2. Provision of written informed consent. 3. Documented history of symptomatic AF (paroxysmal, persistent, or permanent) with a ventricular rate of ≥110 bpm. * Documentation: electrocardiogram (ECG) tracing (including 12-lead ECG or ECG strip) showi...