A nasal spray containing the investigational calcium channel blocker etripamil is efficacious and safe in patients with paroxysmal supraventricular tachycardia, topline results suggest.
The RAPID trial met its primary endpoint demonstrating a “statistically significant and clinically meaningful” difference in the proportion of patients who converted to normal sinus rhythm within 30 minutes of using etripamil vs placebo (64.3% vs 31.2%; hazard ratio, 2.62; 95% CI, 1.66 – 4.15),” Milestone Pharmaceuticals said in a news release.
Safety and tolerability findings were consistent with those seen in prior trials, with the most common treatment-emergent adverse event related to the nasal administration site, the company notes. Most adverse events were reported as mild (68%), 31% were moderate, and none were serious.
In addition, pooled data from the previously reported NODE-301 trial and RAPID “show that etripamil treatment provided a statistically significant reduction in the use of additional medical interventions, and a statistically significant reduction in visits to the emergency department,” Milestone said.
Full results of the RAPID trial, which enrolled 706 patients at centers in the US and Europe, will be presented November 7 in a late-breaking science session at the American Heart Association 2022 Scientific Sessions.
Milestone continues to enroll patients in the open label NODE-303 safety trial and said it plans to submit an new drug application in mid-2023 pending agency feedback.
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