RAPID: Positive Top-line Results for Etripamil Nasal Spray in Paroxysmal SVT

A nasal spray containing etripamil, an investigational calcium channel blocker, significantly benefits patients with paroxysmal supraventricular tachycardia (PSVT), according to top-line results of the RAPID trial released Monday.

Drugmaker Milestone Pharmaceuticals said the phase III trial met its primary endpoint, demonstrating a higher rate of conversion to normal sinus rhythm within 30 minutes in patients who self-administered the active spray compared with placebo (64.3% vs 31.2%; HR 2.62; 95% CI 1.66-4.15). The median time to conversion was “three times faster” with etripamil.

Safety and tolerability were consistent with what has been seen in prior studies, with the most-common adverse events related to nasal administration. Nearly all of the randomized treatment-emergent adverse events were deemed mild (68%) or moderate (31%). There were no serious adverse events related to etripamil.

Moreover, an analysis pooling data from RAPID and the previous NODE-301 study indicated that the nasal spray significantly reduces medical interventions and emergency department visits.

“These data further support the potential for etripamil to deliver a clinically meaningful benefit to patients and an important and valuable tool for their physicians,” Bruce Stambler, MD (Piedmont Heart Institute, Atlanta, GA), said in a company press release.

The RAPID trial, conducted at centers in the US and Europe, randomized 706 patients to a nasal spray containing etripamil or placebo. The spray was self-administered, and patients were instructed to give themselves a second dose if the first didn’t provide symptom relief within 10 minutes.

The results are slated to be presented next month during a late-breaking science session at the American Heart Association 2022 Scientific Sessions in Chicago, IL.

Milestone Pharmaceuticals said it is still enrolling patients in an open-label safety trial (NODE-303) and plans to submit a new drug application to the US Food and Drug Administration in the middle of next year “pending agency feedback.”