Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as MSP-2017
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 nasal spray formulation of etripamil, a small molecule developed by Milestone Pharmaceuticals Inc. (ticker: MIST). It is being studied for the acute treatment of paroxysmal supraventricular tachycardia (PSVT), a condition characterized by episodes of rapid heart rate. Etripamil NS is also known as Etripamil NS 70 mg.
Etripamil NS is being developed for the termination of spontaneous episodes of paroxysmal supraventricular tachycardia (PSVT) in adults and pediatric patients. It is intended for self-administration by patients to rapidly convert PSVT to normal sinus rhythm. The drug is investigational and has not been approved by the FDA.
Etripamil NS targets the CAV1 calcium channel. By blocking this channel, etripamil is thought to slow conduction through the atrioventricular node, which can interrupt the reentrant circuit responsible for paroxysmal supraventricular tachycardia. This mechanism is being evaluated in clinical trials.
Etripamil NS is being developed by Milestone Pharmaceuticals Inc., a biopharmaceutical company with the ticker symbol MIST. Milestone is focused on developing therapies for cardiovascular conditions, including paroxysmal supraventricular tachycardia.
Etripamil NS is in Phase 3 clinical development. The program includes completed Phase 3 trials such as NCT05410860, NCT04952610, and NCT04072835, as well as an ongoing Phase 2 trial (NCT05763953) in pediatric patients. The drug is investigational and has not been approved for any indication.
Etripamil NS has been studied in several clinical trials, including the completed Phase 3 NODE-303 safety study (NCT04072835) with 1,116 patients, the completed Phase 3 efficacy and safety study NCT05410860 with 500 patients, and the completed Phase 3 study NCT04952610 with 130 patients. An ongoing Phase 2 trial, NODE-202 (NCT05763953), is recruiting pediatric patients.