"Clearing clinical and regulatory hurdles in the development of a fast-acting nasal spray for a heart condition has given Milestone Pharmaceuticals its first FDA approval in its 22-year history.
The U.S. regulator has signed off on Cardamyst (etripamil) to quell symptomatic episodes from paroxysmal supraventricular tachycardia (PSVT), which is a type of abnormal heart rhythm. Cardamyst becomes the first self-administered treatment patients can use to manage their PSVT symptoms.The calcium channel blocker is a convenient alternative to an emergency room visit, where patients receive an intravenous dose of a drug that “basically reboots your heart,” Milestone CEO Joe Oliveto said in an interview.“It’s only a few seconds but nevertheless, these people really don’t like it,” Oliveto said, adding that patients have told him receiving the IV treatment is “like a near death experience.”
Nearly as traumatizing for PSVT patients are the heart racing episodes which come sporadically and without warning. Oliveto said some patients have described even just a 10-minute attack of palpitations as feeling like they had run a marathon.
PSVT occurs when a short circuit rhythm develops in the upper chamber of the heart. It causes rapid heartbeat that starts and stops abruptly. The heart rate can run up to 230 beats per minute.
The only treatments used to counter PSVT are prophylactics such as beta blockers, anti-arrhythmic drugs and other calcium channel blockers that are taken orally and provide mixed results in curbing the episodes.
With its ability to provide potentially speedy relief, Oliveto believes Cardamyst can give patients peace of mind and more flexibility as they plan their activities. Oliveto calls it “insurance in my pocket.”
“Seventy percent of patients report anxiety even when they’re not in an event and that’s because they don’t know when an event is going to come,” Oliveto said. “Is it going to happen when I’m with my grand-kids or I’m at work at an important presentation or I’m on a plane to Europe. It’s like they’re walking on eggshells. It’s always there on their minds and the current solution is not great—a trip to the emergency department.”