#China #Nanjing #Simcere #Sanbexin #Stroke Treatment

Sanbexin® Sublingual Tablets: A Breakthrough in Stroke Treatment

On November 2, 2024, the National Medical Products Administration (NMPA) in China granted approval to Simcere Pharmaceutical's innovative Sanbexin® sublingual tablets, marking a significant advancement in the treatment of acute ischemic stroke (AIS). This new formulation, which contains the active ingredients edaravone and dexborneol, aims to enhance recovery from neurological symptoms, promote daily activity, and reduce functional impairment following a stroke.

Understanding Sanbexin®

Sanbexin® functions as a dual-target brain cytoprotective agent with a novel sublingual delivery system. This unique method allows the tablets to dissolve quickly under the tongue, facilitating rapid absorption into the bloodstream. This approach significantly bypasses the first-pass hepatic metabolism seen with traditional oral drugs. As a result, patients can experience quicker relief with improved bioavailability of the active ingredients.

This approval follows the earlier launch of Sanbexin® in injection form in 2020, which has already benefited over 3 million stroke patients in China. This latest innovation further establishes Sanbexin® as the only novel drug approved for stroke in the past decade, with encouraging clinical outcomes reported since its inception.

Clinical Trials and Effectiveness

Extensive clinical trials have substantiated the effectiveness of Sanbexin®. Under the leadership of Professor Fan Dongsheng from Peking University Third Hospital, phase III trials demonstrated that patients receiving Sanbexin® sublingual tablets exhibited a 64.4% functional independence rate at 90 days post-treatment, compared to 54.7% in those given a placebo. These results, published in JAMA Neurology, highlight the promising safety profile and therapeutic impact of Sanbexin® in improving recovery from stroke.

Professor Fan asserted the value of Sanbexin® sublingual tablets, stating their ability to stabilize cerebral health during the acute phase of stroke while also providing a feasible treatment option at home. This aligns well with current hospital practices, where the average hospitalization period for stroke patients is approximately one week, even though effective treatment typically requires longer administration of cytoprotective drugs.

Accessibility and Cost-Effectiveness

One of the standout features of the Sanbexin® sublingual tablets is their accessibility. With the ability for patients to administer the medication at home, this reduces the burden on both healthcare facilities and patients themselves. Experts estimate that this could ultimately translate into lower medical costs and improved quality of life for individuals recovering from stroke.

In addition to its approval in China, Sanbexin® has already garnered recognition from the U.S. Food and Drug Administration (FDA), receiving Breakthrough Therapy Designation for acute ischemic stroke, positioning it as a revolutionary treatment option in international markets. A global multi-centered clinical trial is currently in the pipeline, aiming to expand Sanbexin®'s availability beyond China.

Global Impact and Future Directions

The approval of Sanbexin® sublingual tablets is viewed as a critical step towards reducing stroke-related disabilities not only in China but globally. Experts like Professor Gregory W. Albers from Stanford University are eager to replicate the positive outcomes observed in China through extensive trials in the United States and elsewhere. If successful, Sanbexin® could play a pivotal role in reshaping the treatment landscape of acute ischemic stroke.

As the world continues to face a rising number of stroke cases, the introduction of Sanbexin® sublingual tablets offers renewed hope for patients seeking effective and accessible treatment options, highlighting the importance of innovation in healthcare.

In conclusion, the Sanbexin® sublingual tablet represents a significant leap in pharmaceutical development, combining convenience with efficacy and setting a new standard for stroke care, both in China and worldwide.