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Preclinical Safety Evaluation of Etripamil Nasal Spray in Cynomolgus Macaques () to Assess for Safety in Patients With Paroxysmal Supraventricular Tachycardia.
Int J Toxicol
September 2024
Milestone Pharmaceuticals, Montreal, QC, Canada.
Etripamil is a calcium channel blocker currently in Phase 3 trials for the treatment of paroxysmal supraventricular tachycardia (PSVT). Systemic and local toxicity following once-weekly intranasal administration of etripamil was evaluated in cynomolgus macaques to support clinical development. Groups of animals (N = 8, 4 males and 4 females) were administered etripamil into the left nostril weekly at dose levels of 0 (vehicle), 1.
View Article and Find Full Text PDFIntranasal etripamil for rapid treatment of paroxysmal supraventricular tachycardia.
Future Cardiol
June 2024
Liverpool Centre for Cardiovascular Science at University of Liverpool, Liverpool John Moores University & Liverpool Heart & Chest Hospital, Liverpool, L14 3PE, United Kingdom.
Paroxysmal supraventricular tachycardia (PSVT) is a common arrhythmia that, although usually benign, can occur unpredictably, cause disabling symptoms and significantly impair quality of life. If spontaneous resolution does not occur, the only current self-treatment is for the patient to attempt vagal maneuvers, however, these are frequently unsuccessful. Hospital attendance is then required for intravenous therapy.
View Article and Find Full Text PDFPharmacokinetics and Pharmacodynamics of Etripamil, an Intranasally Administered, Fast-Acting, Nondihydropyridine Calcium Channel Blocker.
Clin Pharmacol Drug Dev
April 2024
Piedmont Heart Institute, Atlanta, GA, USA.
Etripamil, a fast-acting nondihydropyridine L-type calcium channel blocker, is under investigation for potential self-administration for the acute treatment of supraventricular tachyarrhythmias in a medically unsupervised setting. We report detailed pharmacokinetics and pharmacodynamics of intranasally administered etripamil in healthy adults from 2 Phase 1, randomized, double-blind studies: Study MSP-2017-1096 (sequential dose-escalation, crossover study design, n = 64) and NODE-102 (single dose, 4-way crossover study, n = 24). Validated bioanalytical assays determined plasma concentrations of etripamil and its inactive metabolite.
View Article and Find Full Text PDFRationale and design of the NODE-303 study: evaluating the safety of symptom-prompted, self-administered etripamil for paroxysmal supraventricular tachycardia episodes in real-world settings.
Am Heart J
April 2024
Piedmont Healthcare, Atlanta, GA.
Background: Paroxysmal supraventricular tachycardia (PSVT) is a common episodic arrhythmia characterized by unpredictable onset and burdensome symptoms including palpitations, dizziness, chest pain, distress, and shortness of breath. Treatment of acute episodes of PSVT in the clinical setting consists of intravenous adenosine, beta-blockers, and calcium channel blockers (CCBs). Etripamil is an intranasally self-administered L-type CCB in development for acute treatment of AV-nodal dependent PSVT in a nonmedical supervised setting.
View Article and Find Full Text PDFNose-to-Heart Approach: Unveiling an Alternative Route of Acute Treatment.
Biomedicines
January 2024
Medical School, University of Cyprus, Nicosia 2029, Cyprus.
Intranasal (IN) administration has emerged as a novel approach for rapid systemic absorption, with potential applicability in the management of acute cardiovascular events. This review explores the evolution of IN cardiovascular pharmacotherapy, emphasizing its potential in achieving systemic effects and bypassing the first-pass metabolism associated with oral administration. The extensive vascularization of nasal mucosa and a porous endothelial basement membrane facilitate efficient drug absorption into the bloodstream.
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