Simcere Pharmaceutical Group's Sanbexin sublingual tablets, a combination of edaravone and dexborneol, have been granted Breakthrough Therapy designation by the FDA for the treatment of acute ischemic stroke (AIS). This designation, the first for a brain cytoprotection agent, is based on the promising results from the Phase 3 TASTE-SL study, highlighting the potential of Sanbexin to improve neurological outcomes in stroke patients. The sublingual formulation allows for rapid absorption and ease of use, addressing critical needs in emergency stroke interventions.
Clinical Evidence from TASTE-SL Study
The TASTE-SL study, a Phase 3 multicenter, randomized, double-blind, placebo-controlled trial, evaluated the efficacy of Sanbexin in patients with AIS. The results demonstrated statistically significant improvements in functional outcomes compared to placebo. Specifically, 64.4% of patients in the Sanbexin group achieved a modified Rankin Scale (mRS) score of 0 or 1 on day 90, compared to 54.7% in the placebo group (odds ratio, 1.50; 95% CI, 1.15-1.95, p = 0.003). These improvements indicate enhanced neurological recovery and activities of daily living (ADL). The study enrolled patients aged 18 to 80 with a National Institute of Health Stroke Scale score between 6 and 20, and a clinically diagnosed AIS symptom within 48 hours.
Mechanism of Action and Cytoprotective Effects
Sanbexin's combination of edaravone and dexborneol acts as a multi-target brain cytoprotective agent, reducing cascade damages caused by brain ischemic reperfusion. Edaravone is a free radical scavenger, while dexborneol is believed to enhance cerebral circulation and protect neurons. This dual mechanism aims to salvage the ischemic penumbra, the area of brain tissue susceptible to damage during a stroke.
Global Stroke Burden and Unmet Needs
Stroke is a leading cause of death and disability worldwide, with AIS accounting for approximately 70% of all stroke cases. According to The Lancet, there are 12 million new stroke cases and 6.6 million deaths annually. Without urgent measures, global deaths due to stroke are predicted to rise by 50% by 2050, reaching 9.7 million annually, with economic losses potentially amounting to US$2.3 trillion. The FDA Breakthrough Therapy designation highlights the urgent need for more effective stroke treatments.
Regulatory Approval and Future Directions
In addition to the FDA Breakthrough Therapy designation, Sanbexin sublingual tablets have been approved for market in China by the National Medical Products Administration for improving neurological symptoms, ADL impairments, and functional impairments caused by AIS. Sanbexin (edaravone and dexborneol concentrated solution for injection) was previously approved in China in 2020 and included in China’s medical insurance directory, treating over 3 million AIS patients. Phase 2 clinical trials are currently underway in the U.S. to assess the sublingual tablets for post-stroke cognitive impairment (PSCI).
