Sublingual Edaravone Dexborneol Study

Sublingual edaravone dexborneol can rapidly diffuse and be absorbed through the oral mucosa after sublingual exposure. It is a multitarget brain cytoprotection which contains antioxidant and anti-inflammatory ingredients edaravone and dexborneol.

An Original Investigation published in JAMA Neurology has concluded that sublingual edaravone dexborneol can enhance the chances of achieving favorable clinical outcomes at 90 days for individuals with acute ischemic stroke.

Study Overview

Researchers evaluated the efficacy and safety of sublingual edaravone dexborneol on functional outcomes in patients with acute ischemic stroke (AIS) in this double-blind, placebo-controlled, multicenter, parallel-group, phase 3 RCT (June 28, 2021, to August 10, 2022) with a 90-day follow-up.

The study included participants from 33 centres in China aged 18 to 80 years, with a National Institutes of Health Stroke Scale score between 6 and 20, a total motor deficit score of 2 or greater for upper and lower limbs, a clinically diagnosed AIS symptom within 48 hours, and a modified Rankin Scale (mRS) score of 1 or less before the stroke. Patients who did not meet the eligibility criteria or declined participation were excluded.

Patients were randomly assigned to receive sublingual edaravone dexborneol (edaravone, 30 mg; dexborneol, 6 mg) or a placebo (edaravone, 0 mg; dexborneol, 60 μg) twice daily for 14 days.

Key Findings

• Nine hundred fourteen patients of median age, 64 years, were randomly allocated to the edaravone dexborneol or placebo group.
• The edaravone dexborneol group had a significantly higher proportion of patients experiencing good functional outcomes on day 90 after randomization than the placebo group (64.4% vs 54.7% with a risk difference of 9.70% and an odds ratio of 1.50).
• The two groups had a similar adverse event rate (89.8% vs. 90.1%).

Concluding further, in AIS patients treated within 48 hours following the onset of symptoms, sublingual edaravone dexborneol improved 90-day functional outcomes by providing brain cytoprotection.

Reference

Fu Y et al. Sublingual Edaravone Dexborneol for the Treatment of Acute Ischemic Stroke: The TASTE-SL Randomized Clinical Trial. JAMA Neurol. Published online February 19, 2024. doi:10.1001/jamaneurol.2023.5716