Feature | Pharmaceuticals | May 16, 2017

First Nasal Spray Successfully Treats Supraventricular Tachycardia

HRS late-breaking study results show innovative medication has potential to change the way patients are treated for this rapid heart rate arrhythmia

May 16, 2017 – Results of a groundbreaking clinical trial demonstrate the effectiveness of a novel, fast-acting nasal spray therapy called Etripamil to stop a common rapid heart rate condition known as paroxysmal supraventricular tachycardia (PSVT). The multicenter, randomized trial enrolled of 104 patients from more than 35 centers across the U.S. and Canada and the results were presented today at Heart Rhythm 2017, the Heart Rhythm Society’s 38th Annual Scientific Sessions.

PSVT is a rapid heart rate condition that affects approximately 500,000 Americans resulting in more than 50,000 hospital visits every year. In order to restore normal heart rhythm, patients are often treated with adenosine, calcium channel blockers or beta-blockers, which must be administered through an IV in a hospital or monitored setting. There are no existing therapy options that can be administered by a patient at their home or without the presence of a trained medical professional. Etripamil, made by Milestone Pharmaceuticals, is a novel, potent, short-acting calcium channel blocker and is being developed as a fast-acting nasal spray that can be administered by the patient to acutely terminate PSVT episodes wherever and whenever they occur. 

The NODE-1 Trial is a phase two, multicenter, randomized, parallel-group, double-blind placebo-controlled study designed to evaluate the efficacy of different doses of Etripamil in terminating PSVT. The study included 104 patients that were randomized and received the drug in an electrophysiology (EP) lab setting. Following a 5-minute induced atrioventricular re-entry tachycardia (AVRT) or atrioventricular nodal reentrant tachycardia (AVNRT), types of PSVT, patients received a placebo or one of four doses of Etripamil at 35 milligrams (mg), 70 mg, 105 mg or 140 mg. The primary endpoint was the termination rate of PSVT within 15 minutes of study drug administration.

Etripamil at doses of 70 mg, 105 mg and 140 mg yielded conversion rates of 87%, 75% and 95%, respectively that were all significantly better than the 35% conversion rate in the placebo group. The mean conversion time ranged from 2.60 minutes to 3.37 minutes in the Etripamil groups. Times were faster with patients given higher doses. The most common adverse event that occurred to patients who used the Etripamil therapy 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,” said lead author Bruce Stambler, M.D., a cardiac electrophysiologist at Piedmont Heart Institute in Atlanta, Ga. “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 authors of this study call for further assessment to test Etripamil in a “real-world” situation of patient self-administration outside of the hospital environment. 

Watch the VIDEO interview with Bruce S. Stambler, M.D., FHRS, as he reviews the Heart Rhythm 2017 Late-Breaking Clinical Trial: "Intranasal Etripamil For Conversion Of Paroxysmal Supraventricular Tachycardia (Psvt). NODE-1 Trial".

Read the article in Heart Rhythm Journal: heartrhythmjournal.com/article/S1547-5271(17)30587-8/fulltext

For more information: www.hrssessions.org, www.HRSonline.org

Related Content

Biotronik Announces U.S. Launch of Edora HF-T QP CRT Pacemaker
Technology | Cardiac Resynchronization Therapy Devices (CRT)| August 21, 2017
Biotronik announced U.S. Food and Drug Administration (FDA) approval and commercial availability of Edora HF-T QP, an...
Medtronic Announces Global Resolute Onyx DES One-Month DAPT Study
News | Antiplatelet and Anticoagulation Therapies| August 18, 2017
Medtronic plc announced a global randomized clinical trial that will evaluate one-month dual antiplatelet therapy (DAPT...
The FDA is concerned about cybersecurity of ICDs and cyber security of other medical devices.
Feature | Cybersecurity| August 16, 2017 | Dave Fornell
There is growing concern among patients and regulators that medical devices, especially implantable electrophysiology
Bivalirudin exhibited an improvement in 30-day all-cause mortality when injected post PCI.
News | Antiplatelet and Anticoagulation Therapies| August 16, 2017
August 16, 2017 — A study has examined the efficacies of various post-percutaneous coronary intervention (PCI) bivali
ESC 2017 late breaking trial hot line study presentations.
News | Clinical Study| August 16, 2017
Aug. 16, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking Clinic
News | Drug-Eluting Balloons| August 15, 2017
Surmodics Inc. announced receipt of an investigational device exemption (IDE) from the U.S. Food and Drug...
The Vascular Dynamics MobiusHD device enhances the carotid baroreceptors to reduce resistant hypertension.
News | Hypertension| August 15, 2017
Aug. 15, 2017 — The U.S. Food and Drug Administration (FDA) has approved the Vascular Dynamics Inc.
Abbott Initiates First Clinical Trial of Clip-Based Tricuspid Repair System
News | Heart Valve Technology| August 09, 2017
Abbott announced that the first patient has been enrolled in a clinical study to evaluate a minimally invasive clip-...
Overlay Init