FDA Approves CARDAMYST Nasal Spray as First Self-Administered Treatment for PSVT in Over 30 Years
核心洞察
The FDA has approved CARDAMYST (etripamil) nasal spray, marking the first new treatment option for paroxysmal supraventricular tachycardia (搜索) (PSVT (搜索)) in over 30 years for more than 2 million Americans with the condition.
The novel calcium channel blocker allows patients to self-administer treatment outside healthcare settings, potentially avoiding emergency department visits and providing greater control over unpredictable PSVT (搜索) episodes.
Clinical trials demonstrated that patients using CARDAMYST were twice as likely to convert to normal heart rhythm within 30 minutes compared to placebo, with a median conversion time of 17 minutes versus 54 minutes for placebo.
Milestone Pharmaceuticals announced that the U.S. Food and Drug Administration has approved CARDAMYST (etripamil) nasal spray for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (搜索) (PSVT (搜索)) to sinus rhythm in adults. This approval represents the first new treatment option for PSVT in more than 30 years, offering over 2 million Americans with the condition a rapid-acting therapy they can self-administer outside emergency departments or healthcare facilities.
CARDAMYST is expected to be available in retail pharmacies in the first quarter of 2026, providing patients with an at-the-ready treatment option for managing the unpredictable episodes characteristic of PSVT (搜索).
Novel Self-Administration Approach
The approval addresses a significant unmet medical need for patients with PSVT (搜索), who previously required intravenous treatments administered in healthcare settings. CARDAMYST nasal spray is a novel calcium channel blocker designed to rapidly resolve PSVT episodes and restore normal heart rhythm when self-administered at symptom onset.
"Some people with PSVT (搜索) have endured years of anxiety, fearing their next episode and the stress and disruption of emergency department visits," said James Ip, M.D., FACC, FHRS, an etripamil investigator. "CARDAMYST will give many of them the ability to administer a medication themselves that can quickly stop their PSVT episode and potentially avoid a hospital trip or a call to emergency services."
Robust Clinical Evidence
The FDA approval is supported by comprehensive clinical trial data from more than 1,800 participants and over 2,000 episodes of PSVT (搜索). The pivotal Phase 3 RAPID trial, published in The Lancet in 2023, demonstrated significant efficacy compared to placebo in a global, randomized, double-blind study.
In the RAPID trial, 64% of participants who self-administered CARDAMYST (N=99) converted from supraventricular tachycardia to sinus rhythm within 30 minutes compared to 31% on placebo (N=85), achieving a hazard ratio of 2.62 (p<0.001). At one hour, the benefit was demonstrated in 73% of participants treated with CARDAMYST.
The treatment effect was evident early and sustained, with a median time to conversion of 17 minutes (95% CI: 13.4, 26.5) for CARDAMYST versus 54 minutes (95% CI: 38.7, 87.3) for placebo. Patients using CARDAMYST were twice as likely to convert symptomatic PSVT (搜索) to sinus rhythm and did so more than three times faster compared with placebo.
Safety Profile and Tolerability
Clinical studies demonstrated a consistent safety profile across all patient subgroups, including those concurrently taking beta blockers or calcium channel blockers. The most frequent adverse events occurring in ≥5% of participants were mild-to-moderate and transient, including local-site nasal discomfort, nasal congestion, rhinorrhea, throat irritation, and epistaxis. Less than 2% of trial participants discontinued therapy due to adverse events.
A collective analysis of the NODE program trials, presented at the American Heart Association's 2025 Scientific Sessions, showed that 59.6% of patients exposed to etripamil converted to normal sinus rhythm within 30 minutes, with a median time to conversion of 18.5 minutes (95% CI, 15.7-21). Test dose failure occurred in only 1.4% of patients, highlighting the treatment's favorable tolerability profile.
Addressing Significant Disease Burden
PSVT (搜索) affects an estimated 2 million people in the United States and is characterized by episodes of sudden onset rapid heartbeats often exceeding 150 to 200 beats per minute. These unpredictable episodes may last several hours and cause disabling symptoms including severe palpitations, shortness of breath, chest discomfort, dizziness, and distress, forcing patients to limit daily activities.
The uncertainty of when episodes will occur can provoke anxiety and negatively impact quality of life between episodes. Many healthcare providers have been dissatisfied with the lack of effective treatment options, which often require prolonged, burdensome, and costly emergency department visits or invasive cardiac ablation procedures.
Commercial Launch and Future Development
Milestone is well-capitalized to launch and commercialize CARDAMYST with existing capital and royalty financing. As of September 30, 2025, the company had cash, cash equivalents, and short-term investments of $82.6 million. Additionally, Milestone has a $75.0 million royalty purchase agreement with RTW Investments (搜索) that is expected to be triggered by the FDA approval.
"Our goal is that CARDAMYST will become a trusted and essential solution for healthcare providers and their patients," said Lorenz Muller, Chief Commercial Officer of Milestone. "Our team is focused on making CARDAMYST available to adults with PSVT (搜索) as quickly as possible, including actively working to secure insurance coverage and begin the distribution of the product through retail pharmacies."
The company is also positioned to advance etripamil development for atrial fibrillation with rapid ventricular rate (搜索) (AFib-RVR (搜索)), leveraging the successful ReVeRA Phase 2 trial results published in Circulation: Arrhythmia and Electrophysiology. Milestone plans to pursue a supplemental New Drug Application pathway for this potential second indication, utilizing a single pivotal Phase 3 study in AFib-RVR patients.