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FDA Breakthrough: A Nasal Spray That Stops a Racing Heart in Minutes #heart #fda #news

In this video it is defined that
According to an article published in fiercepharma.com By Kevin Dunleavy on Dec 15, 2025 that
Milestone Pharmaceuticals has gained its first FDA approval, winning a nod for Cardamyst, a nasal spray to treat sudden episodes of the heart racing condition paroxysmal supraventricular tachycardia.
Paroxysmal supraventricular tachycardia — or PSVT — is a condition caused by a short-circuit rhythm in the upper chambers of the heart.
When it strikes, the heart suddenly begins beating extremely fast, sometimes up to 230 beats per minute, then stops just as abruptly.
Patients describe even a 10-minute episode as feeling like they’ve just run a marathon.
And the worst part?
It can happen anytime.
At work.
On a plane.
With family.
Until now, treatment options were far from ideal.
Patients relied on:
Daily preventive medications like beta blockers
Anti-arrhythmic drugs
Or calcium channel blockers taken orally
But these often provided mixed results.
When an episode became severe, the only real solution was a trip to the emergency room, where patients receive an intravenous drug that, in the words of Milestone’s CEO…
A fast-acting nasal spray containing etripamil, a calcium channel blocker.
With this FDA approval, Cardamyst becomes the first self-administered treatment for sudden PSVT episodes.
No ER visit.
No IV.
No waiting.
Just one spray in each nostril.
And if symptoms don’t stop within 10 minutes?
Patients can take a second dose.
As Oliveto calls it:
“Insurance in my pocket.”
The science backs it up.
In clinical trials:
64% of patients using Cardamyst successfully terminated their PSVT episode
Compared to just 31% on placebo
That’s twice as effective. And three times faster than placebo. These results came after Milestone refined its Phase 3 trial — allowing a second dose and shortening the evaluation window to 30 minutes. That change boosted success rates by an additional 10 to 15 percent.
But this approval isn’t just about numbers. It’s about peace of mind.
According to Milestone, nearly 70% of PSVT patients experience anxiety even when they’re not having an episode — simply because they don’t know when the next one will strike.
Will it happen during an important meeting?
While traveling?
With their grandkids?
Cardamyst gives patients control, confidence, and freedom they’ve never had before.