Data from a 100-patient clinical trial showed that a fast-acting nasal spray therapy, etripamil, was effective at stopping a common rapid heart rate condition, researchers said today at the annual Heart Rhythm Society conference in Chicago.
Paroxysmal supraventricular tachycardia is traditionally treated with adenosine, calcium channel blockers or beta blockers, which is administered using an IV in a clinical setting. There are no available treatments that can be administered by a patient at home.
Milestone Pharmaceutical‘s etripamil is a short-acting calcium channel blocker that is being designed as a fast-acting nasal spray to quickly stop PSVT episodes wherever and whenever they occur.
The Node-1 trial randomized 104 patients to receive the drug in an electrophysiology lab setting. After a 5-minute induced atrioventricular re-entry tachycardia or atrioventricular nodal reentrant tachycardia, patients received either a placebo or one of 4 doses of etripamil.
The study’s primary endpoint was the PSVT termination rate within 15 minutes of drug administration.
At doses of 70 milligram, 105 mg, and 140 mg, etripamil demonstrated conversion rates of 87%, 75% and 95%, respectively. The placebo group achieved a 35% conversion rate.
The mean time to conversion ranged from 2.6 minutes to 3.4 minutes among the patients in the Etripamil groups.
The most common adverse event for patients treated with Entripamil was transient nasal congestion or irritation.
“This study introduces a completely novel therapy that has never been used before, and has the potential to alter how we treat patients with PSVT,” lead author Dr. Bruce Stambler said in prepared remarks. “Many patients who suffer from PSVT can experience sudden episodes anytime and anywhere. This fast-acting nasal spray therapy could give patients the convenience to self-administer treatment no matter the location and without having to go to the hospital.”
The study’s authors said the next assessment should evaluate etripamil in a real-world situation, where patients self-administer the nasal spray outside of a clinical environment.
Correction: An earlier version of the article misspelled the name of Milestone’s product as “entripamil”. The error has been corrected.