Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Etripamil NS · 4 trials · 2 indications
The primary efficacy endpoint is defined as an adjudicated termination of a positively adjudicated episode of PSVT (AV nodal reentrant tachycardia or AV reentrant tachycardia determination if possible) and conversion to sinus rhythm (SR) for at least 30 seconds within 30 minutes of start of study drug dosing.
Number of participants with any adverse events experienced from baseline up to the final study visit including the treatment of up to 4 perceived PSVT episodes.
A successful conversion is defined as conversion of PSVT to SR that is maintained for at least 30 seconds
| Arm | Type | Description |
|---|---|---|
| Etripamil NS 70 mg with Optional Second Dose | EXPERIMENTAL | Dosing regimen that permits a second dose of Etripamil NS 70 mg |
| Placebo with Optional Second Dose | EXPERIMENTAL | Dosing regimen that permits a second dose of placebo |
| Etripamil NS 70 mg | EXPERIMENTAL | Self- administration of a dose of 70 mg of etripamil. Patients will be provided with a maximum of 4 pre-filled devices at a time. If the symptoms of PSVT persist 10 minutes after the first dose of etripamil NS 70 mg, a second dose of etripamil NS 70 mg can be self-administered by the patient. A second dose of etripamil NS 70 mg should be taken not earlier than 10, and not later than 15 minutes after the first dose. |
| Etripamil NS | EXPERIMENTAL | Participants self-administered etripamil NS 70 mg. After implementation of protocol amendment 2.1 (16 March 2021), participants had the option to administer a second dose of etripamil 70 mg 10 minutes after the first dose, if PSVT symptoms persisted |
| Not Treated | NO_INTERVENTION | Participants not treated with etripamil NS for a PSVT episode. |
| Etripamil NS 70mg | EXPERIMENTAL | Patients will be administered by study site personnel |
| Name | Type | Description |
|---|---|---|
| Etripamil NS 70 mg | 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. |
| Placebo | DRUG | Placebo 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. |
| Aptar Pharma Nasal Spray Bidose System | DEVICE | Aptar Pharma Nasal Spray Bidose System will be supplied as prefilled devices packaged into child-resistant boxes with instructions for use provided in the study drug box. |
| Etripamil NS | DRUG | Participants were provided with an ambulatory Cardiac Monitoring System (CMS) to help document PSVT episodes. The CMS was self-applied by the participant, when PSVT symptoms begin. Participants self-administered etripamil NS if vagal maneuver was ineffective. After implementation of protocol amendment 2.1, participants had the option to administer a second dose of etripamil 70 mg 10 minutes after the first dose, if symptoms persisted. After an episode of PSVT where drug was administered, the participant returned to the investigative site for a study visit and was given the option to continue in NODE-303 and manage up to three subsequent episodes of PSVT with etripamil NS for a maximum of four episodes. |
Inclusion Criteria: Patients who meet all of the following criteria will be eligible to participate in the study: 1. Male or female patients at least 18 years of age; 2. Electrographically documented history of PSVT (e.g., diagnosis based on ECG , Holter monitoring, etc.). If patient had a prior a...
Etripamil NS is an investigational small molecule nasal spray being developed for paroxysmal supraventricular tachycardia (PSVT) and supraventricular tachycardia. It is designed for patients to self-administer during episodes of rapid heart rate to terminate the arrhythmia. The drug is currently in Phase 3 clinical development.
Etripamil NS is being developed by Milestone Pharmaceuticals Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol MIST. The company is conducting clinical trials to evaluate the safety and efficacy of this nasal spray formulation for the treatment of paroxysmal supraventricular tachycardia.
Etripamil NS is in Phase 3 clinical development for paroxysmal supraventricular tachycardia and supraventricular tachycardia. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. Multiple Phase 3 trials have been completed, and a Phase 2 trial in pediatric patients is currently recruiting.
Etripamil NS has been studied in several clinical trials. Completed Phase 3 trials include NODE-303 (NCT04072835) with 1,116 patients, NCT04952610 with 130 patients, and NCT05410860 with 500 patients in China. An ongoing Phase 2 trial, NODE-202 (NCT05763953), is recruiting pediatric patients aged 6 years and older.
Etripamil NS is not FDA approved. It is an investigational drug currently in clinical development for paroxysmal supraventricular tachycardia. The drug has completed Phase 3 trials, but regulatory approval has not been granted. Milestone Pharmaceuticals continues to evaluate its safety and efficacy through ongoing clinical studies.
Etripamil NS is a small molecule nasal spray designed to act on the heart to terminate episodes of paroxysmal supraventricular tachycardia. While the specific molecular target is not disclosed, the drug is formulated for rapid absorption through the nasal mucosa to provide quick relief during arrhythmia episodes. Its exact mechanism of action is under clinical investigation.