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letter
. 2023 Nov 10;12(4):545–555. doi: 10.1007/s40119-023-00335-4
Paroxysmal supraventricular tachycardia (PSVT) is a recurrent episodic condition in which patients suffer from sudden-onset symptoms inducing palpitations, dyspnea, syncope, and psychological distress; current approved treatments require medical supervision.
The phase 3 RAPID trial, NODE-301 part 2, was designed to evaluate a symptom-prompted, optional repeat dose of etripamil, an investigative calcium channel blocker (CCB) that can be self-administered intranasally; RAPID assessed the safety and efficacy of etripamil while noting safety effects from one or two doses that were self-administered by patients.
Eligible adults with a history of PSVT were randomized to etripamil or placebo groups, and they self-administered the study drug upon perceiving PSVT symptoms; significantly superior conversion rates of PSVT to sinus rhythm were observed within 30 min in participants treated with etripamil (64%) versus those treated with placebo (31%).
The increased drug exposure achieved with RAPID’s repeat-dose protocol was well tolerated, without any additional safety signals beyond the transient mild and moderate treatment-emergent adverse events observed with a single dose of etripamil, which were mostly associated with the medication administration site.
These data support the potential use of etripamil as a fast-acting, convenient medication that can be used by patients with PSVT to quickly and safely terminate episodes outside a clinical setting without medical supervision.