CARDAMYST™ (etripamil) nasal spray is now available in U.S. pharmacies as a self-administered treatment for acute PSVT episodes in adults. Learn who can use it, key safety warnings, side effects, and details on FDA approval and EMA review.
Written By: Pharmacally Medical News Desk
Milestone Pharmaceuticals has announced that CARDAMYST™ (Etripamil) nasal spray is now available through retail pharmacies across the United States. This marks an important step for adults living with paroxysmal supraventricular tachycardia (PSVT), a condition that causes sudden episodes of abnormally fast heart rhythm.
CARDAMYST is a prescription nasal spray designed to help convert acute symptomatic PSVT episodes back to a normal rhythm (sinus rhythm), offering patients a convenient treatment that can be used wherever an episode occurs. The U.S. FDA approved CARDAMYST on December 12, 2025, making it the first FDA-approved treatment for PSVT in more than 30 years.
What is PSVT and Why is CARDAMYST Important?
PSVT is a type of rapid heart rhythm that often begins suddenly and may cause symptoms such as:
Palpitations or racing heartbeat
Chest discomfort
Dizziness or fainting
Shortness of breath
Anxiety during episodes
Many patients with PSVT have traditionally relied on emergency visits or hospital-based treatments. CARDAMYST provides a self-administered option, allowing patients to manage episodes more quickly outside of the hospital setting.
Availability and Commercial Launch Plan
Milestone confirmed that CARDAMYST is now being distributed through U.S. pharmacies, with a rapid commercialization plan underway. A national sales force is expected to be deployed by mid-February 2026 to support awareness and access.
CEO Joseph Oliveto highlighted that patients have been waiting for a treatment that helps them take greater control of unpredictable PSVT episodes.
Patient Support and Copay Assistance Program
To improve affordability and reduce barriers to treatment, CARDAMYST is launching alongside a dedicated patient assistance platform, which includes:
- Insurance benefits verification
- Reimbursement support
- Administrative assistance
- Copay support for eligible patients
For most commercially insured patients, copays are expected to be capped at $25, reinforcing Milestone’s commitment to access and affordability.
Who Should NOT Use CARDAMYST?
CARDAMYST is not appropriate for everyone. Do not use this medication if you:
- Are allergic to Etripamil or any ingredient in CARDAMYST
- Have moderate to severe heart failure limiting activity
- Have Wolff-Parkinson-White (WPW) syndrome or related abnormal rhythm patterns
- Have sick sinus syndrome without a permanent pacemaker
- Have second-degree or higher AV block
Always review the full prescribing information with your healthcare provider.
Important Precautions Before Using CARDAMYST
Tell your healthcare provider if you have:
- History of fainting
- Low blood pressure
- Pregnancy or plans to become pregnant
- Breastfeeding plans
Breastfeeding patients are advised to pump and discard breast milk for 12 hours after using CARDAMYST. Also inform your provider about all medications and supplements you take, including herbal products.
Possible Side Effects: What Patients Should Watch For
CARDAMYST may cause serious side effects, especially related to blood pressure and heart rhythm.
Risk of dizziness or fainting
Some patients may experience:
- Light-headedness
- Dizziness
- Fainting (syncope)
For safety:
- Use CARDAMYST while seated
- Lie down if you feel dizzy
- Caregivers should seek urgent medical help if fainting occurs
This risk may be higher in patients with previous fainting episodes or certain heart conditions.
EMA Acceptance for Review: Global Regulatory Progress
In addition to U.S. approval, Milestone has also announced that the European Medicines Agency (EMA) has accepted the marketing application for etripamil nasal spray for review in PSVT.
If approved, it could become the first self-administered therapy for PSVT in Europe, with a regulatory decision expected in 2027.
References
Milestone Pharmaceuticals Announces U.S. Availability of CARDAMYST™ (etripamil) Nasal Spray, the First and Only FDA-Approved Self-Administered Treatment for Adults with Paroxysmal Supraventricular Tachycardia (PSVT), 26 January 2026, Milestone Pharmaceuticals Announces U.S. Availability of CARDAMYST™ (etripamil) Nasal Spray, the First and Only FDA-Approved Self-Administered Treatment for Adults with Paroxysmal Supraventricular Tachycardia (PSVT) | Milestone Pharmaceuticals, Inc.
FDA Approves CARDAMYST™ (Etripamil) as First Self-Administered Nasal Spray for Paroxysmal Supraventricular Tachycardia, 14 December 2025, https://pharmacally.com/fda-approves-cardamyst-etripamil-as-first-self-administered-nasal-spray-for-paroxysmal-supraventricular-tachycardia/
Milestone’s Etripamil Nasal Spray Accepted for EMA Review in PSVT, 10 January 2026, https://pharmacally.com/milestones-etripamil-nasal-spray-accepted-for-ema-review-in-psvt/