전한울
2024년 9월 7일
- Edaravone dexborneol is a multi-target medication with both antioxidant and anti-inflammatory characteristics.
According to a recent announcement, the FDA has granted breakthrough therapy designation to Simcere Pharmaceuticals’ edaravone and dexborneol sublingual tablets (Sanbexin) for the treatment of acute ischemic stroke (AIS), becoming the first innovative drug globally to be given this designation in stroke by the agency.1 The formulation of the brain cytoprotective agent, composed of 2 active ingredients with synergistic anti-oxidant and anti-inflammatory effects, can quickly disintegrate once in contact with salvia placed under the tongue, being absorbed into the blood.
This designation was based on the data published in JAMA Neurology from the phase 3 TASTE-SL study (NCT04950920) which demonstrated that treatment with the medication improved the rate of functional outcomes in patients with AIS who presented within 48 hours.2 In the trial, investigators randomly assigned those with AIS to edaravone dexborneol (n = 450) or placebo (edaravone, 0 mg; dexborneol, 60 ug) twice daily for 14 days with follow-up that lasted until 90 days. At the conclusion of the study, good functional outcome, defined as modified Rankin Scale (mRS) scores of 1 or less, were achieved in 64.4% of those on active treatment vs 54.7% of those on placebo (OR, 1.50; 95% CI, 1.15-1.95; P = .003).
"Sanbexin sublingual tablets is effective in improving neurological function recovery and independent living ability of ischemic stroke patients after treatment and apply to a variety of treatment scenarios,” senior author Dongsheng Fan, MD, PhD, the director of the neurological department at Peking University Third Hospital and a professor of neurology at Peking University, said in a statement.3 “This phase 3 study of Sanbexin sublingual tablet also provides a high-quality evidence-based basis for clinical brain cell protection, which provides a strong guarantee for stroke treatment."
TASTE-SL was a phase 3 multicenter, randomized, double-blind, parallel, placebo-controlled study comprised of patients aged 18 to 80 years old with a National Institutes of Health Stroke Scale score between 6 and 20, a total motor deficit score of the upper and lower limbs of 2 or greater, a clinically diagnosed AIS symptom within 48 hours, and an mRS score of 1 or less before stroke. All patients included in the trial were of Chinese Han ethnicity.
<연관된 논문 및 clinical trial 정보>
https://clinicaltrials.gov/study/NCT04950920
https://www.ahajournals.org/doi/10.1161/STROKEAHA.120.031197
<해당 약물에 대한 기초논문> https://doi.org/10.1016/j.intimp.2022.109315
•Edaravone dexborneol is a multi-target medication with both antioxidant and anti-inflammatory characteristics.
•Edaravone dexborneol plays a protective role in ischemic brain injury by regulating microglia pyroptosis.
•Edaravone dexborneol produces neuroprotective benefits by suppressing the NF-κB/NLRP3/GSDMD signaling pathway.
•Edaravone dexborneol may have a significant role in extending the therapeutic window for acute ischemic stroke.