Sanbexin is the first innovative drug for stroke treatment with Breakthrough Therapy designation in the world. Clinical trial results demonstrated that the fast-acting sublingual tablets led to statistically significant improvements in functional outcomes in patients compared with placebo.
The Sanbexin sublingual tablets (edaravone and dexborneol) developed by the Chinese pharmaceutical company Simcere have been granted the Breakthrough Therapy designation by FDA for the treatment of acute ischemic stroke (AIS) recently.
This prestigious designation is backed by significant improvements in efficacy endpoints in the TASTE-SL study, a Phase 3 multicenter, randomized, double-blind, parallel-group, placebo-controlled trial. The results showed improvements in neurological recovery and activities of daily living (ADL) achieved by Sanbexin compared with placebo.
“The FDA Breakthrough Therapy designation not only recognizes the innovation and potential efficacy of Sanbexin, but also highlights the urgent global needs for more effective stroke treatments,” stated Dr. Felix Wang, Senior Vice President of Simcere Pharmaceutical Group Limited. “This designation will expedite the development and review processes, which is essential for a novel drug designed to treat serious, life-threatening conditions.”
In parallel with the FDA Breakthrough Therapy designation in the U.S., Sanbexin sublingual tablets have been approved for market in China by the National Medical Products Administration on December 1, with the first indication aiming at the improvement of neurological symptoms, ADL impairments, and functional impairments caused by AIS.
According to The Lancet, stroke ranks as the second leading cause of death and disability worldwide, with an incidence of 12 million new cases and 6.6 million deaths annually. AIS is the most prevalent type of stroke, accounting for about 70% of all stroke cases, underscoring the importance of timely intervention. As highlighted in “Pragmatic Solutions to Reduce the Global Burden of Stroke”, a report published by The Lancet Neurology in collaboration with the World Stroke Organization, if no urgent measures are taken, the 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 major goal of intervention in AIS is to salvage the ischemic penumbra—a vital area of brain tissue susceptible to damages. Effective brain cytoprotection has the capability of reducing ischemic brain injury by antagonizing detrimental molecule cascades.
The TASTE-SL study recruited patients from 33 centers aged 18 and 80 who had a National Institute of Health Stroke Scale score of between 6 and 20. They also had a motor deficit score of the upper and lower limbs of 2 or greater, a clinically diagnosed AIS symptom within 48 hours, and a modified Rankin Scale (mRS) score of 1 or less before stroke. Of 956 patients, 42 were excluded.
Among the 914 patients included, the median age was 64 and 66.5% were male. Approximately 49.2% of the patients received Sanbexin sublingual tablets, while the remainder received placebo tablets.
A favorable outcome of an mRS score of 1 or less on day 90 occurred in 64.4% of the patients in the edaravone dexborneol group and 54.7% in the placebo group (odds ratio, 1.50; 95%CI, 1.15-1.95, p = 0.003). Adverse reactions (AR) were comparable between Sanbexin and placebo groups, with metabolic and nutrition disorders being the most common AR.
“The combination of edaravone and dexborneol as active ingredients enables Sanbexin to serve as a multi-target brain cytoprotective agent, significantly reducing cascade damages caused by brain ischemic reperfusion,” Dr. Felix Wang added, emphasizing the drug’s effect on patient recovery.
Professor Dongsheng Fan from Peking University Third Hospital, the principal investigator of this study project, noted, “The TASTE-SL study has provided high-quality evidence-based data for clinical brain cytoprotection, offering robust support for stroke treatment.”
“Breakthrough Therapy designation from FDA is a very big deal. This is the first time it’s happened for a brain cytoprotection agent,” said Dr. Gregory W. Albers, the director of Stanford Stroke Center, Stanford Medical Center. “The sublingual formulation is very easy to give in any stroke setting. A larger number of patients were less disabled because of the medication. With efficacy, a long time window to treatment, and without significant adverse effects, this medication has tremendous potential.”
The designation was granted also due to the sublingual route of administration of the tablets. Unlike other systemic administration drugs which have to travel a longer route to reach liver, reducing the amount and potential potency of the drug being administered, Sanbexin sublingual tablets quickly enters the brain and circulation system once it contacts with saliva beneath the tongue.
As early as 2020, Sanbexin (edaravone and dexborneol concentrated solution for injection) was approved for marketing in China and included in China’s medical insurance directory. Over the past four years, it has treated more than 3 million AIS patients and received wide recognition among clinicians and patients. At current stage, the injection and sublingual formulations are expected to be combined as a sequential therapy, facilitating a complete course of brain cytoprotection for stroke patients to achieve better efficacy.
Yongjun Wang, president of Beijing Tiantan Hospital, emphasized, “The Sanbexin sublingual tablets after marketing will provide patients with further brain cytoprotection and neuroprotection after hospital discharge, making it easier to complete the full course of treatment, thereby simplifying the treatment process for patients and lowering the economic burdens.”
As the first innovative drug globally to receive FDA Breakthrough Therapy designation for stroke treatment, Sanbexin sublingual tablets have already completed Phase 1 clinical trials in healthy volunteers in the U.S. Additionally, Phase 2 clinical trials assessing the sublingual tablets for post-stroke cognitive impairment (PSCI) are currently underway. Looking ahead, Sanbexin sublingual tablets is positioned to not only serve as acute stroke treatments, but also to address subacute and chronic cerebrovascular diseases, thereby benefiting a wider patient population.
“With its rapid absorption and ease of use, Sanbexin sublingual tablets address the crucial needs for effective stroke interventions in emergency settings, benefiting patients worldwide,” concluded Dr. Felix Wang.
