Ji Xing Pharmaceuticals has announced positive topline data from its Phase III clinical trial of the etripamil nasal spray to treat paroxysmal supraventricular tachycardia (PSVT).
The randomised, multi-centre, double-blind, placebo-controlled trial was conducted across more than 40 hospitals in China.
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It enrolled 500 subjects to assess the efficacy and safety of the self-administered nasal spray.
Subjects were randomised into a 1:1 ratio to receive a nasal spray of either etripamil (70mg) or placebo without medical supervision.
They had an option to self-administer a second dose after ten minutes if symptom relief was not achieved.
According to the findings, the primary endpoint of the trial was met.
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By GlobalDataA Kaplan Meier analysis indicated a statistically significant greater proportion of subjects converted to a normal rhythm within 30 minutes when using etripamil versus placebo (40.5% vs. 15.9%).
Secondary efficacy endpoints were also met at various time points up to 60 minutes post-administration.
The treatment-emergent adverse events (TEAEs) were comparable between the etripamil and placebo arms in the trial.
Furthermore, no serious adverse events linked to etripamil were reported.
The majority of common adverse events, occurring within 24 hours of administration, were associated with the nasal delivery method.
Ji Xing Pharmaceuticals Cardiovascular chief medical officer Yuan Li said: “We will engage with the regulatory authorities to advance the new drug application for etripamil with the aim of bringing this innovative therapy to patients with PSVT in China as soon as possible.
“Once etripamil gains approval, we are confident that it will not only empower patients to self-manage their PSVT episodes but will also create significant value for the entire healthcare system by reducing the frequency of emergency department visits.”
