Milestone Pharmaceuticals to Present Data on CARDAMYST™ (etripamil) Nasal Spray at the 2026 American College of Cardiology Annual Scientific Session
MONTREAL and CHARLOTTE, N.C., March 16, 2026 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (NASDAQ:MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced that a moderated poster presentation titled "Minimal Blood Pressure Effects of Intranasal Etripamil in Trials for Paroxysmal Supraventricular Tachycardia (PSVT)" will be featured at the 2026 American College of Cardiology Annual Scientific Session (ACC.26), March 28-30th in New Orleans, La. An Expert Theater will also be conducted at ACC.26, providing a deeper look at this new treatment option for adults with symptomatic PSVT.
"Although potential hypotension is a known class effect of calcium channel blockers, this analysis from Milestone's etripamil Phase 3 program shows that etripamil had a minimal impact on blood pressure after test dosing and very low rates of hypotension," said David Bharucha, M.D., PhD, Chief Medical Officer of Milestone Pharmaceuticals. "We believe these data support the potential for safe self-administration by patients of intranasal etripamil for PSVT outside the clinical setting."
Data Highlights
- Etripamil (CARDAMYST™), a novel calcium channel blocker (CCB) nasal spray, was FDA-approved as the first and only self-administered treatment for adults with symptomatic PSVT in December 2025 and is under investigation for atrial fibrillation with rapid ventricular rate. The Phase 3 trials that evaluated the product in PSVT included NODE-301 parts 1-3, NODE-302, and NODE-303.
- CCBs are associated with a risk of hypotension, therefore blood pressure (BP) or symptoms of hypotension were diligently assessed.
- Mean heart rate (HR) and BP change from baseline were analyzed for 30 to 45 minutes post-test dose of etripamil 70 mg in NODE 301 parts 1-3. Patients self-administered either a single or repeat TD (2 x 70 mg). 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).
- Among 1,610 patients, TEAEs of hypotension and syncope within 24 hours were 0.4% (N=7) and 0.2% (N=4), respectively. Two of the four AEs of syncope occurred prior to drug administration. All TEAEs resolved without medical intervention.
- The authors concluded that although CCBs generally carry a potential risk of hypotension, these data demonstrate minimal BP reduction during test dose and rare symptoms of hypotension or syncope, supporting the potential safe self-administration of etripamil for PSVT treatment.
| Presentation Details | |
| Moderated Poster Presentation Title: | Minimal Blood Pressure Effects of Intranasal Etripamil in Trials for Paroxysmal Supraventricular Tachycardia |
| Presenter: | Narendra Singh, M.D., Clinical Assistant Professor, Medical College of Georgia at Augusta University and Mercer University, Atlanta. Director, Clinical Research-NSC Research |
| Date and Time: | Sunday, March 29, 2026, 10:06 – 10:13am CT |
| Location: | Moderated Poster Theater 10, Posters, Hall E |
| Presentation Number: | 1089-09 |
| 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. | |
| Presentation Details: | |
| Expert Theater: | Discover the First and Only FDA-Approved Nasal Spray to Treat PSVT in Adults* |
| Presenter: | Farhad Rafii, M.D., Clinical Study Investigator |
| Date and Time: | Monday, March 30, 2026, 12:00-1:00pmCT |
| Location: | IET #3 (Booth 2863) |
| *This event is not part of ACC.26, as planned by its Program Committee, and does not qualify for continuing medical education (CME), continuing nursing education (CNE) or continuing education (CE) credit. | |
Attendees can learn more about CARDAMYST by visiting Booth #319.
About CARDAMYST
CARDAMYST™ (etripamil) nasal spray is approved by the U.S. Food and Drug Administration (FDA) for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults. It is a novel calcium channel blocker nasal spray designed as a self-administered rapid response therapy for patients, thereby bypassing the need for immediate medical oversight. The product is intended to provide health care providers with a new treatment option to enable on-demand care and patient self-management. This portable treatment may provide patients with active management and a greater sense of control over their condition. CARDAMYST is well studied with a robust clinical trial program that includes a completed Phase 3 clinical-stage program for the treatment of PSVT. Currently, etripamil is in Phase 2 development for treatment of PSVT in pediatric patients and Phase 3 development for acute control of atrial fibrillation with rapid ventricular rate (AFib-RVR) in adults. For more information, please visit CARDAMYST.com.
Indication
CARDAMYST is indicated for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults.
IMPORTANT SAFETY INFORMATION FOR CARDAMYST (etripamil)
What is CARDAMYST?
CARDAMYST is a prescription medicine used to help restore normal sinus heart rhythm in adults who have symptoms of sudden episodes of fast heartbeat called paroxysmal supraventricular tachycardia (PSVT).
It is not known if CARDAMYST is safe and effective in children.
Do not use CARDAMYST if you:
- are allergic to CARDAMYST or any of its ingredients. See the Patient Information for a complete list of ingredients in CARDAMYST.
- have limitations in activities due to heart failure (moderate to severe heart failure).
- have Wolff-Parkinson-White (WPW) syndrome, Lown-Ganong-Levine syndrome, or an abnormal heart rhythm pattern called pre-excitation (delta wave) on an electrocardiogram (ECG).
- have sick sinus syndrome without a permanent pacemaker.
- have second degree or higher atrioventricular (AV) block.
Before using CARDAMYST, tell your healthcare provider about all of your medical conditions, including if you:
- have a history of fainting.
- have low blood pressure.
- are pregnant or plan to become pregnant. It is not known if CARDAMYST will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if CARDAMYST passes into your breast milk. You should stop breastfeeding for 12 hours after treatment with CARDAMYST. During this time, pump and throw away your breast milk. Talk to your healthcare provider about the best way to feed your baby after using CARDAMYST.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What are the possible side effects of CARDAMYST?
CARDAMYST may cause serious side effects, including:
- Fainting due to CARDAMYST effects on blood pressure, heart rate, and electrical activity of the heart. CARDAMYST may cause dizziness and fainting, especially in people with a history of fainting and certain heart problems, or people with a history of fainting during an episode of PSVT. Use CARDAMYST while sitting in a safe area where you will not fall if you become dizzy or lightheaded. Lie down if you feel dizzy or lightheaded after using CARDAMYST. If fainting occurs after using CARDAMYST, caregivers should place you on your back and seek medical help.
The most common side effects of CARDAMYST include:
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These are not all of the possible side effects for CARDAMYST. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Please see the full Prescribing Information https://milestonepharma.com/etripamilprescribinginformation.pdf for CARDAMYST.
About Milestone Pharmaceuticals
Milestone Pharmaceuticals Inc. (NASDAQ:MIST) is an emerging commercial-stage biopharmaceutical company advancing innovative cardiovascular medicines to benefit people living with certain heart conditions. Milestone's lead product is CARDAMYST™ (etripamil) nasal spray, a novel calcium channel blocker, which is FDA approved for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults. Etripamil is also in development for the control of symptomatic episodic attacks associated with AFib-RVR.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "believe," "continue," "could," "demonstrate," "designed," "develop," "estimate," "expect," "may," "pending," "plan," "potential," "progress," "will", "intend" and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Milestone's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding: Milestone's exp expectations in regards to etripamil's efficacy and its safe self-administration by patients outside the clinical setting; Milestone's research, development and regulatory plans for etripamil; and other statements not related to historical facts. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, but are not limited to, whether Milestone's future interactions with the EMA will have satisfactory outcomes; whether and when, if at all, Milestone's MMA for etripamil will be approved by the EMA; uncertainties related to the timing of initiation, enrollment, completion, evaluation and results of Milestone's clinical trials; risks and uncertainty related to the complexity inherent in cleaning, verifying and analyzing trial data; and whether the clinical trials will validate the safety and efficacy of etripamil for PSVT or other indications, among others, general economic, political, and market conditions, including deteriorating market conditions due to investor concerns regarding inflation, international tariffs, Russian hostilities in Ukraine and ongoing disputes in the Middle East and overall fluctuations in the financial markets in the United States and abroad, risks related to pandemics and public health emergencies, and risks related the sufficiency of Milestone's capital resources and its ability to raise additional capital in the current economic climate. These and other risks are set forth in Milestone's filings with the U.S. Securities and Exchange Commission (SEC), including in its annual report on Form 10-K for the year ended December 31, 2025 and its quarterly report on Form 10-Q for the quarter ended September 30, 2025, in each case under the caption "Risk Factors," as such discussions may be updated from time to time by subsequent filings Milestone may make with the SEC. Except as required by law, Milestone assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.
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