Novel Brain Cytoprotection Combination Therapy Associated with Improved Functional Outcomes in People with Acute Ischemic Stroke

The use of Sanbexin (edaravone and dexborneol; Simcere, Nanjing, China) sublingual tablets, a formulation combining edaravone and dexborneol, was found to result in statistically significant improvements in functional outcomes for people with acute ischemic stroke (AIS) compared with placebo. The finding is based on results of the TASTE-SL clinical trial (NCT04950920), conducted in China, and published in JAMA Neurology.

TASTE-SL was a randomized, double-blind, placebo-controlled, multicenter, parallel-group, phase 3 clinical trial that included 914 adult participants aged 18 to 80 years with clinically diagnosed AIS symptoms within 48 hours. Eligibility criteria included:

• A National Institutes of Health Stroke Scale (NIHSS) score between 6 and 20
• A total motor deficit score of the upper and lower limbs of ≥2
• A modified Rankin Scale (mRS) score of ≤1 before stroke

The participants were randomly assigned 1:1 to receive either Sanbexin at 36 mg (30 mg of edaravone, 6 mg of dexborneol) (n=450) or placebo (n=464) twice daily for 14 days with 90 days of follow up. The primary efficacy outcome was the proportion of participants with an mRS score of ≤1 on day 90 after randomization.

The proportion of participants achieving an mRS of ≤1 was greater in the Sanbexin group (64.4%) compared to the placebo group (54.7%), suggesting that Sanbexin was effective in improving functional outcomes after AIS (risk difference, 9.70%; 95% CI, 3.37% to 16.03%; odds ratio, 1.20; 95% CI, 1.15 to 1.95; P=.003). The risk of adverse events was similar in the Sanbexin group (89.8%) and placebo group (90.1%).

“In the field of stroke treatment, the continued exploration of brain cell protection therapy is beginning to show promise,” said Professor Wang Yongun, President of Beijing Tiantan Hospital of Capital Medical University. “Following the TASTE study, which validated the clinical benefit of edaravone dexamethasone injection, the TASTE-SL study further confirmed the efficacy and safety of the sublingual dosage form in the AIS population, and a more convenient way of administering the drug is expected to push the brain cell protection to home treatment."