Cardamyst (etripamil) / Milestone - LARVOL DELTA

Self-Administered Etripamil and Emergency Department Visits in Supraventricular Tachycardia: A Secondary Analysis of a Randomized Clinical Trial. (PubMed, JAMA Cardiol) - No abstract available

Clinical • Journal • Cardiovascular • Ventricular Tachycardia

THE SAFETY AND EFFICACY OF ETRIPAMIL IN PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA (PSVT) - Alexander Sacher (ACC 2025) - "This meta-analysis concludes that etripamil can be a safe and effective non-parenteral option for treating cardiac arrhythmias. ."

Clinical • Atrial Fibrillation • Cardiovascular • Ventricular Tachycardia

CONSISTENCY AND PREDICTIVENESS OF CONVERSION AMONG MULTIPLE EPISODES OF PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA (PSVT) TREATED WITH ETRIPAMIL: OUTCOMES FROM NODE-303 - James E. Ip (ACC 2025) - "Conversion of PSVT to SR with etripamil occurred in the majority of patients over multiple episodes, and conversion in earlier episodes was consistently predictive of conversion in subsequent episodes. These data support potential efficacy of etripamil to treat successive episodes of PSVT."

Cardiovascular • Ventricular Tachycardia

Cardiovascular and Pharmacokinetic Profiles of Intravenous Etripamil in Conscious Telemetered Cynomolgus Monkeys. (PubMed, Int J Toxicol) - "Results were consistent with data from subsequent intranasal preclinical and clinical studies. Intravenous etripamil demonstrated the desired targeted pharmacokinetic and pharmacodynamic profiles in conscious cynomolgus monkeys."

Journal • PK/PD data • Cardiovascular • Ventricular Tachycardia

FDA Issues Complete Response Letter for Etripamil for PSVT (GlobeNewswire) - "Milestone Pharmaceuticals Inc...announced the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding its New Drug Application (NDA) for CARDAMYST (etripamil) nasal spray, a prescription medication in development for the conversion of acute episodes of PSVT to sinus rhythm in adults. The FDA did not raise any concerns regarding etripamil clinical safety or efficacy data and highlighted two key Chemistry, Manufacturing and Controls (CMC) issues to be addressed: Company to submit additional information on nitrosamine impurities based on new draft guidance issued after the NDA submission; and An inspection is required at a facility that performs release testing for etripamil, to ensure it is in compliance with Current Good Manufacturing Practices. The facility changed ownership during the review of the NDA."

CRL • Atrial Fibrillation • Cardiovascular • Ventricular Tachycardia

Milestone Pharmaceuticals to Present Clinical Data on Etripamil at the American College of Cardiology (GlobeNewswire) - "Milestone Pharmaceuticals Inc...today announced that it will present a moderated poster presentation at the American College of Cardiology annual meeting (ACC25), to be held March 29th to 31st, 2025 in Chicago, Illinois....This presentation highlights the potential ability of etripamil to successfully convert multiple episodes of Paroxysmal Supraventricular Tachycardia (PSVT) to restore normal sinus rhythm."

P3 data • Ventricular Tachycardia

Milestone Pharmaceuticals Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Regulatory and Corporate Update (GlobeNewswire) - "Poster on Etripamil to be presented at American College of Cardiology Annual Meeting (ACC.25) The poster...is scheduled to be presented on March 30, 2025 by James Ip, M.D., Division of Cardiology, Weill Cornell Medicine, New York Presbyterian Hospital...Milestone is on track to initiate a Phase 3 trial evaluating etripamil in AFib-RVR in 2025."

New P3 trial • P3 data • Atrial Fibrillation • Cardiovascular • Ventricular Tachycardia

Self-administered intranasal etripamil: a new treatment to keep SVT out of the ED? (PubMed, CJEM) - No abstract available

Journal

Milestone Pharmaceuticals Notice of Allowance on New U.S. Patent for Etripamil (GlobeNewswire) - "Milestone Pharmaceuticals Inc...today announced that it has received Notice of Allowance from the United States Patent and Trademark Office (USPTO) on a new Method of Use patent for etripamil nasal spray (proposed trade name CARDAMYST), its lead investigational product for the management of paroxysmal supraventricular tachycardia (PSVT)....The issuance of the Notice of Allowance potentially extends our intellectual property protection for CARDAMYST in the United States until July 2042, which is an additional 6 years of potential protection for our intellectual property portfolio."

Patent • Ventricular Tachycardia

Milestone Pharmaceuticals to Host Commercial Launch Plan Investor Event in New York on February 25, 2025 - "Milestone Pharmaceuticals Inc...announced further details on its in-person and virtual Commercial Launch Plan investor event to take place in New York on Tuesday, February 25, 2025 from 10:30 AM to 12:30 PM ET...Featuring presentations by Joseph Oliveto, President and Chief Executive Officer, and Lorenz Muller, Chief Commercial Officer, the event will provide an overview of Milestone’s commercial strategy for etripamil nasal spray (proposed trade name CARDAMYST), its lead investigational product for the management of paroxysmal supraventricular tachycardia (PSVT)....Milestone currently expects to launch in PSVT mid-2025."

Launch US • Ventricular Tachycardia

Milestone Pharmaceuticals Provides 2025 Corporate Outlook and Will Host Investor Event on February 25 in NYC (GlobeNewswire) - "FDA Prescription Drug User Fee Act (PDUFA) target date is March 27, 2025...Launch in PSVT targeted for mid-2025...The company will host a live investor event to provide an overview of its commercial strategy for CARDAMYST....Upcoming Medical Conferences. Assuming approval on the PDUFA date, Milestone will have its first branded product presence at ACC.2025 (American College of Cardiology annual meeting, March 29 to 31, 2025 in Chicago) and the Heart Rhythm Society Annual Meeting (April 24 to 27, 2025 in San Diego)."

Launch US • PDUFA • Cardiovascular • Ventricular Tachycardia

Etripamil for patients with atrial fibrillation with rapid ventricular rate (AFib-RVR) (GlobeNewswire) - "Phase 3 pivotal trial in AFib-RVR expected to begin enrollment in H1 2025. Milestone plans to initiate a trial of etripamil nasal spray in patients with AFib-RVR in the at-home setting. The protocol has been finalized, incorporating FDA feedback, and the study is sized based on achieving approximately 150 events in patients with symptomatic episodes. A self-administered, repeat-dose regimen of 70 mg/dose will be evaluated (the same approach that was studied in the successful RAPID trial in PSVT)."

New P3 trial • Atrial Fibrillation

Efficacy and Safety Study of Etripamil Nasal Spray Self-Administration for the Termination of Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia (clinicaltrials.gov) - P3 | N=500 | Completed | Sponsor: Corxel Pharmaceuticals | Active, not recruiting ➔ Completed

Trial completion • Cardiovascular • Ventricular Tachycardia

Quality of Life Measures with Etripamil Self-Administration for Acute Episodes of Paroxysmal Supraventricular Tachycardia in a Medically Unsupervised Setting: Patient-Reported Outcomes from NODE-303 (CVCT USA 2024) - No abstract available

Clinical • HEOR • Patient reported outcomes • Cardiovascular • Ventricular Tachycardia

Concomitant Antiarrhythmic Use Among Patients Who Received Etripamil For Atrial Fibrillation With Rapid Ventricular Rate (CVCT USA 2024) - No abstract available

Clinical • Atrial Fibrillation • Cardiovascular

ReVeRA-301: Etripamil in Atrial Fibrillation Phase 3 (clinicaltrials.gov) - P3 | N=750 | Not yet recruiting | Sponsor: Milestone Pharmaceuticals Inc.

New P3 trial • Atrial Fibrillation • Cardiovascular

Self-Administered Etripamil Nasal Spray Relieved Symptoms, Decreased Heart Rate, and Reduced Medical Interventions During Atrioventricular Nodal-Dependent Paroxysmal Supraventricular Tachycardia. (PubMed, Circ Arrhythm Electrophysiol) - No abstract available

Journal • Cardiovascular • Ventricular Tachycardia

Frequency and Patterns of Paroxysmal Supraventricular Tachycardia Episodes Among Patients Opting For Acute Drug Treatment: Analysis of the NODE-303 Open-Label Etripamil Trial (AHA 2024) - "This analysis aimed to assess the annualized use of etripamil NS in a real-world setting, by analyzing how often patients would self-administer the drug for PSVT episodes. Of patients that self-administered etripamil (n=503), the majority treated >1 episode and the annualized frequency of episodes treated with etripamil was 3.2 episodes/yr."

Clinical • Cardiovascular • Ventricular Tachycardia

Nasal Etripamil Spray efficacy for Acute Paroxysmal Supraventricular Tachycardia: A Systematic Review, Meta-Analysis and Trial Sequential Analysis. (AHA 2024) - "Nasal Etripamil is effective and safe for the treatment of acute PSVT, offering a non-invasive alternative to traditional therapies. Larger-scale RCTs are warranted to confirm these findings and explore long-term outcomes."

Retrospective data • Review • Cardiovascular • Ventricular Tachycardia

Concomitant Antiarrhythmic Use Among Patients Who Received Etripamil For Atrial Fibrillation With Rapid Ventricular Rate (HFSA 2024) - "Patients with symptomatic AF-RVR who received etripamil NS had less frequent use of NDHP CCBs, BB, and digoxin in the 24 hours following treatment than patients who received placebo."

Clinical • Atrial Fibrillation • Cardiovascular • Ventricular Tachycardia

Etripamil Use In Atrial Fibrillation With Rapid Ventricular Rate (HFSA 2024) - "In both studies, etripamil NS significantly reduced VR rapidly after drug administration, which is consistent with its pharmacologic profile."

Atrial Fibrillation • Cardiovascular • Ventricular Tachycardia

Quality of life measures with etripamil self-administration for acute episodes of paroxysmal supraventricular tachycardia in a medically unsupervised setting: patient-reported outcomes from NODE-303 (ESC 2024) - "Etripamil self-administration was associated with patient-reported improvements in degree of disease severity, decreased anxiety and stress over future PSVT episodes, and levels of treatment satisfaction, effectiveness, and convenience considered favorable for respective PRO instrument. Using a symptom-prompted, self-administered treatment for PSVT could potentially improve QoL measures and reduce healthcare resource utilization."

Clinical • HEOR • Patient reported outcomes • Cardiovascular • Ventricular Tachycardia

Efficacy of etripamil nasal spray for acute conversion of supraventricular tachycardia: a network meta-analysis. (PubMed, Cardiol J) - No abstract available

Journal • Retrospective data • Cardiovascular • Ventricular Tachycardia

Efficacy and Safety Study of Etripamil Nasal Spray Self-Administration for the Termination of Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia (clinicaltrials.gov) - P3 | N=500 | Active, not recruiting | Sponsor: Ji Xing Pharmaceuticals (Shanghai) Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular • Ventricular Tachycardia

Preclinical Safety Evaluation of Etripamil Nasal Spray in Cynomolgus Macaques (Macaca fascicularis) to Assess for Safety in Patients With Paroxysmal Supraventricular Tachycardia. (PubMed, Int J Toxicol) - "The NOAEL for local toxicity was 1.9 mg/kg/dose. Collectively, these data support further study of etripamil in human trials as a potential treatment for PSVT."

Journal • Preclinical • Cardiovascular • Ventricular Tachycardia