Ji Xing Pharmaceuticals has unveiled positive results from its Phase III clinical trial of etripamil nasal spray for treating paroxysmal supraventricular tachycardia (PSVT).
The trial was a randomized, multi-center, double-blind, placebo-controlled study conducted at over 40 hospitals across China. It involved 500 participants who were tested to evaluate the effectiveness and safety of the self-administered nasal spray.
Participants were randomly assigned to receive either etripamil (70 mg) or a placebo in a 1:1 ratio without medical supervision. They had the option to take a second dose after ten minutes if they did not experience relief.
Analysis using Kaplan-Meier curves showed that a significantly higher percentage of patients using etripamil converted to a normal heart rhythm within 30 minutes compared to those using the placebo (40.5% vs. 15.9%). Secondary endpoints also showed positive results at various times up to 60 minutes after administration.
The incidence of treatment-emergent adverse events (TEAEs) was similar between the etripamil and placebo groups. No serious adverse events related to etripamil were reported. Most common side effects, observed within 24 hours of administration, were associated with the nasal delivery method.
Yuan Li, Chief Medical Officer of Cardiovascular at Ji Xing Pharmaceuticals, stated, “We will work with regulatory authorities to advance the new drug application for etripamil, aiming to bring this innovative treatment to PSVT patients in China as soon as possible. We believe that once approved, etripamil will empower patients to manage their PSVT episodes independently and reduce the need for emergency department visits, thereby benefiting the entire healthcare system.”
