Cardamyst (etripamil) / Milestone, Everest Medicines - LARVOL DELTA

Milestone Pharmaceuticals Enrolls First Canadian Study Participant in ReVeRA-301 Phase 3 Pivotal Trial Evaluating Etripamil Nasal Spray for AFib-RVR (GlobeNewswire) - "The expansion into Canada advances the multinational study toward its target of 150 patients with treated AFib-RVR events. ReVeRA-301 is evaluating the same 70 mg repeat-dose regimen that is U.S. Food and Drug Administration (FDA)-approved for paroxysmal supraventricular tachycardia (PSVT) as CARDAMYST (etripamil) nasal spray."

Enrollment open • Atrial Fibrillation

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

Enrollment open • Atrial Fibrillation • Cardiovascular

Everest Medicines…announced that China’s National Medical Products Administration (NMPA) has approved CARDAMYST (etripamil) for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults. (Macau Business) - "The approval of CARDAMYST was supported by the global pivotal Phase III RAPID trial and the Phase III JX02002 study in China. Both studies met their primary endpoints."

China approval • Cardiovascular • Ventricular Tachycardia

Milestone Pharmaceuticals Announces NMPA Approval of Etripamil Nasal Spray for PSVT in China, Marking First Regulatory Approval of Etripamil Outside of the United States (The Manila Times) - "The NMPA decision marks the first regulatory approval of etripamil outside the United States and triggers a $2.0 million milestone payment to Milestone Pharmaceuticals...The NMPA approval was based on data from the global pivotal Phase 3 RAPID study and the Phase 3 JX02002 study conducted in China."

China approval • Commercial • Ventricular Tachycardia

Regulatory and Clinical Updates (Yahoo Finance) - "Regulatory review of the marketing authorization application for etripamil for PSVT in Europe remains on track for a decision from the European Medicines Agency (EMA) in the first half of 2027. The New Drug Application for etripamil for PSVT in China is currently under review by China's National Medical Products Administration (NMPA). Our partner, Everest Medicines, is responsible for engagement with the NMPA for the program."

China filing • EMA approval • Ventricular Tachycardia

Phase 3 registrational trial in atrial fibrillation with rapid ventricular rate (AFib-RVR) is now open and enrolling patients. (Yahoo Finance) - "ReVeRA-301 Phase 3 registrational trial evaluating self-administered etripamil as a potential treatment for patients with AFib-RVR is now open, with several sites activated and evaluating patients for enrollment. Previously announced plans to enroll the first patient in the second half of 2026 remain on track. The Company intends to follow the supplemental New Drug Application (sNDA) regulatory approval pathway and expects to leverage the initial PSVT indication and its safety database along with the results from the planned Phase 3 study in AFib-RVR."

Trial status • Atrial Fibrillation

Launch Progress for CARDAMYST (Yahoo Finance) - "More than 800 unique prescribers have started patients on CARDAMYST through June 30, compared to approximately 200 at the end of Q1; More than 1,500 scripts for CARDAMYST have been filled for more than 1,300 patients with PSVT through June 30, 2026, compared to approximately 300 scripts for 300 patients at the end of Q1; Commercial lives covered remained relatively unchanged through Q2 at approximately 25%; however, covered lives have significantly grown to approximately 50% to date as a result of recently reported formulary coverage for CARDAMYST from UnitedHealthcare and several other prominent commercial insurers; CARDAMYST has been nominated for the 2026 Prix Galien USA Awards for 'Best Pharmaceutical Product.'"

Commercial • Ventricular Tachycardia

Paroxysmal Supraventricular Tachycardia Treatment: Evaluating the Evidence for Established and Newly Approved Options. (PubMed, JACC Adv) - "Approved in late 2025, etripamil nasal spray represents a promising advancement that may provide a safe, effective, self-administered therapy used outside of health care setting. In this review, we examine the existing evidence and practical limitations of current PSVT treatments and discuss the potential clinical implications of etripamil as a novel, rapidly acting, self-administered therapy for the termination of acute symptomatic PSVT."

Journal • Review • Cardiovascular • Ventricular Tachycardia

Etripamil: The First FDA-Approved Intranasal L-Type Calcium Channel Blocker for Acute Termination of Paroxysmal Supraventricular Tachycardia. (PubMed, Ann Pharmacother) - "Etripamil is an effective and well-tolerated intranasal medication for the acute treatment of PSVT in adults, providing rapid conversion to sinus rhythm and offering a safe, patient-administered option to reduce symptom burden and potentially decrease emergency department utilization."

FDA event • Journal • Review • Atrial Fibrillation • Cardiovascular • Ventricular Tachycardia

Minimal Blood Pressure Effects of Intranasal Etripamil for Paroxysmal Supraventricular Tachycardia. (PubMed, JACC Adv) - No abstract available

Journal • Cardiovascular • Ventricular Tachycardia

The present and future of antiarrhythmic drugs. (PubMed, JRSM Cardiovasc Dis) - "Flecainide, propafenone, and dronedarone have demonstrated their reliable efficacy and safety, even in patients with structural heart disease, which should allow clinicians to reduce their reliance on amiodarone. Previous concerns regarding the proarrhythmic risk of dofetilide and ibutilide are currently managed through careful patient selection and adequate QT interval monitoring. Novel targeted AADs are advancing through the development pipeline, of which etripamil and landiolol have already been approved. Other emerging drugs, such as SK channel blockers (AP30663 and AP31969), RyR2 blockers, CaMKII inhibitors, and TASK-1 blockers (doxapram), are aligned with the new paradigm of atrial fibrillation that focuses on triggers and re-entry...Developing concepts such as atrial cardiomyopathy allows clinicians to characterize substrate objectively, in order to assess disease severity and individualize antiarrhythmic treatment. The future of antiarrhythmic therapy will be..."

Journal • Atrial Fibrillation • Cardiomyopathy • Cardiovascular • Heart Failure

Etripamil Nasal Spray in Patients With Paroxysmal Supraventricular Tachycardia (clinicaltrials.gov) - P3 | N=130 | Completed | Sponsor: Milestone Pharmaceuticals Inc. | Enrolling by invitation ➔ Completed

Trial completion • Cardiovascular • Ventricular Tachycardia

Launch Progress for CARDAMYST (Yahoo Finance) - "A total of approximately 600 scripts for CARDAMYST have been filled for 560 patients with PSVT through April; Approximately 400 unique prescribers have started patients on CARDAMYST; Over 25% of commercially insured lives in the U.S. now have coverage for CARDAMYST."

Commercial • Ventricular Tachycardia

Etripamil global expansion advancing in Europe… (Yahoo Finance) - "The MAA incorporates the global clinical data package that supported the FDA approval of etripamil for the treatment of PSVT. TACHYMIST is the conditionally approved brand name for etripamil nasal spray in Europe. A European decision on approval is expected by the first half of 2027."

EMA approval • Ventricular Tachycardia

Etripamil: First Approval. (PubMed, Drugs) - "Additional global regulatory filings of etripamil for PSVT in adults, a phase II trial of etripamil in pediatrics, and a phase III trial for AF-RVR are in progress. This article summarizes the milestones in the development of etripamil leading to this first approval for PSVT."

Journal • Atrial Fibrillation • Cardiovascular • Pediatrics • Ventricular Tachycardia

Milestone Pharmaceuticals Announces RESET-PSVT Registry to Generate Real-World Evidence on CARDAMYST (etripamil) Nasal Spray in Patients With PSVT (The Manila Times) - "Registry Study Design Presented at the Preventive Cardiovascular Nurses Association 2026 Cardiovascular Nursing Symposium...The study will be led by the Duke Clinical Research Institute (DCRI)...RESET-PSVT is expected to enroll an estimated 450 adult patients across approximately 20 electrophysiology and cardiology sites, with enrollment beginning by the end of 2026. The registry is designed to evaluate patients who have been prescribed CARDAMYST as well as patients prescribed or given other therapies, with enrolled patients and their healthcare providers completing patient- and provider-outcome surveys, respectively."

New P4 trial • Ventricular Tachycardia

Cardiovascular pharmacotherapy in year in 2025. (PubMed, Eur Heart J Cardiovasc Pharmacother) - "Here, we summarize the most relevant advances in cardiovascular pharmacotherapy in 2025, including the approval of four new drugs (aficamten, etripamil, lerodalcibep, and plozasiran), the label expansions for five already approved drugs, and the results of major randomized clinical trials with already approved drugs, including those that met the prespecified primary endpoints (positive trials) representing new pharmacological options for cardiovascular diseases, those with neutral or negative results which did not confirm the primary endpoints and the withdrawal from the U.S. market of Andexanet-alfa for safety concerns. Finally, we present the most promising experimental cardiovascular drugs currently being investigated in ongoing phase 2 and 3 clinical trials."

Clinical • Journal • Cardiovascular

Etripamil nasal spray (Cardamyst) for paroxysmal supraventricular tachycardia. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Cardiovascular • Ventricular Tachycardia

Milestone Pharmaceuticals Inc...announced that Express Scripts, one of the nation’s largest pharmacy benefit managers, has added CARDAMYST (etripamil) nasal spray to its commercial national formularies, effective March 27, 2026. (Yahoo Finance) - "This inclusion makes CARDAMYST broadly accessible and affordable for their commercially insured lives across the United States."

Launch US • Ventricular Tachycardia

Everest Medicines Enters into Asset Purchase Agreement with Corxel Pharmaceuticals to Develop and Commercialize CARDAMYST (Etripamil) Nasal Spray in Greater China (The Manila Times) - "Under the terms of the agreement, Everest will pay CORXEL an upfront payment of US$30 million (equivalent to approximately RMB344,895,000), as well as potential development milestone payments of up to US$20 million (equivalent to approximately RMB137,958,000). As part of this agreement, Everest will be assigned and transferred rights, interests, claims, duties, obligations and liabilities (other than certain excluded liabilities) under the Milestone License Agreement entered into by CORXEL in May 2021 and certain related ancillary agreements....In China, the New Drug Application (NDA) for etripamil nasal spray...is expected to receive approval in the third quarter of 2026."

China approval • Licensing / partnership • Atrial Fibrillation • Ventricular Tachycardia

Milestone Pharmaceuticals Reports Fourth Quarter and Full Year 2025 Financial Results... (Milestone Pharma Press Release) - "The MAA incorporates the global clinical data package that supported the FDA approval of etripamil for the treatment of PSVT. A European decision on approval is expected by the first half of 2027...The Company has developed a Phase 3 registrational program (incorporating the FDA’s guidance) to evaluate self-administered etripamil as a potential treatment for patients with AFib-RVR. The Company intends to follow the supplemental New Drug Application (sNDA) regulatory approval pathway and expects to leverage the initial PSVT indication along with the results from the planned single Phase 3 study."

EMA approval • Trial status • Atrial Fibrillation • Ventricular Tachycardia

Milestone Pharmaceuticals to Present Data on CARDAMYST (etripamil) Nasal Spray at the 2026 American College of Cardiology Annual Scientific Session (GlobeNewswire) - "The Phase 3 trials that evaluated the product in PSVT included NODE-301 parts 1-3, NODE-302, and NODE-303...The authors report a descriptive analysis of symptoms of potential hypotension or syncope treatment-emergent adverse events (TEAEs) across Phase 3 trials of PSVT episodes, self-treated outside of the clinical setting; Minimal change from baseline HR and BP was observed following an etripamil test dose, while the patients were in sinus rhythm. Mean systolic BP change was 1.8 mmHg (SD 11.2) over 30 min for single 70 mg dose (N=440) and 0.0 mmHg (SD 12.0) over 45 min for repeat doses (N=714)...Separately, a sponsored Expert Theater will be held at ACC.26 to explore the potential role of CARDAMYST as an emerging therapy to treat symptomatic episodes of PSVT in adults."

P3 data • Ventricular Tachycardia

MINIMAL BLOOD PRESSURE EFFECTS OF INTRANASAL ETRIPAMIL IN TRIALS FOR PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA (ACC 2026) - "Though CCBs carry a potential risk of hypotension, these data demonstrate minimal BP reduction during TD and rare symptoms of hypotension or syncope, supporting the potential safe, self-administration of etripamil for PSVT treatment."

Atrial Fibrillation • Cardiovascular • Hypotension • Ventricular Tachycardia

Self-Administered Etripamil Nasal Spray Slows Ventricular Rate in Patients With Atrial Fibrillation: A Post Hoc Analysis of the NODE-303 Study. (PubMed, J Cardiovasc Electrophysiol) - P3 | "Self-administered etripamil may help to acutely control symptomatic AF-RVR episodes outside of the healthcare setting."

Journal • Retrospective data • Atrial Fibrillation • Cardiovascular • Ventricular Tachycardia

Advances in Antiarrhythmic Drug Therapy: Pharmacologic Management of Supraventricular Tachycardia. (PubMed, Card Electrophysiol Clin) - "Emerging self-administered therapies-particularly intranasal etripamil and selective A1 agonists-promise convenient, rapid conversion outside hospital settings. An individualized, guideline-driven strategy balancing efficacy, safety, and patient preference remains central to optimal supraventricular tachycardia care."

Journal • Review • Cardiovascular • Ventricular Tachycardia