FDA Grants Breakthrough Therapy Designation to Sanbexin for Acute Ischemic Stroke
The FDA granted breakthrough therapy designation to edaravone and dexborneol sublingual tablets (Sanbexin; Simcere Pharmaceuticals) for acute ischemic stroke. The phase 3 trial showed significant neurological recovery and independent living ability improvement compared to placebo. The sublingual formulation allows rapid absorption, with 64.4% achieving mRS score of 1 or less on day 90 in the study drug group versus 54.7% in the placebo group. Adverse events were similar between groups.
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Sanbexin sublingual tablets, developed by Simcere and NeuroDawn, received FDA 'breakthrough therapy' designation for Acute Ischemic Stroke (AIS). The sublingual form offers rapid absorption, better safety than injections, and flexibility in treatment. The NDA for Sanbexin sublingual tablets was accepted by China's NMPA on June 28, 2023, targeting AIS-related neurological symptoms and functional impairment.
FDA grants breakthrough therapy designation to Simcere's edaravone and dexborneol sublingual tablets (Sanbexin) for acute ischemic stroke, based on TASTE-SL phase 3 study data showing improved functional outcomes within 48 hours. The study, led by Dongsheng Fan, demonstrated a 64.4% good functional outcome rate in treated patients vs 54.7% in placebo, with similar safety profiles. Craig S. Anderson highlights the potential implications of this low-cost, easily administered treatment, though its relevance may be limited to Chinese populations.
The FDA granted breakthrough therapy designation to edaravone and dexborneol sublingual tablets (Sanbexin; Simcere Pharmaceuticals) for acute ischemic stroke. The phase 3 trial showed significant neurological recovery and independent living ability improvement compared to placebo. The sublingual formulation allows rapid absorption, with 64.4% achieving mRS score of 1 or less on day 90 in the study drug group versus 54.7% in the placebo group. Adverse events were similar between groups.
Simcere's Sanbexin Sublingual Tablets granted Breakthrough Therapy designation by FDA for Acute Ischemic Stroke treatment. Chengdu's cross-border e-commerce sees 276% growth in import-export declarations, driven by mature China Europe Express Railway and expanding trade corridors.
Simcere Pharmaceuticals' Sanbexin Sublingual Tablets, an innovative stroke treatment, received FDA Breakthrough Therapy designation for Acute Ischemic Stroke, based on significant efficacy improvements in a Phase III clinical study. The sublingual formulation aims to expedite treatment and improve patient outcomes.