Sanbexin sublingual tablet is a new drug jointly developed by Chinese pharmaceutical companies Simcere and NeuroDawn based on the clinical demands of Acute Ischemic Stroke (AIS) patients for more timely and sufficient treatment after stroke onset.
The sublingual dose form is designed for direct absorption by the sublingual mucosa that bypasses the first-pass metabolism and hence facilitates rapid absorption of the drug into the systemic circulation. More importantly, sublingual tablet has better safety and accessibility than injections, therefore is potentially more suitable for timely rescue of AIS patients before they reach hospital or medication at home after being discharged from hospital.
On September 2 last, Simcere Pharmaceuticals Group Ltd announced that Sanbexin Sublingual tablets (Edaravone and Dexborneol sublingual tablets), an innovative drug for stroke, has been granted the 'breakthrough therapy' designation by the U.S. Food and Drug Administration (FDA) for the treatment of Acute Ischemic Stroke (AIS).
Sanbexin sublingual tablets is the first innovative drug in the world designated with the breakthrough therapy by the FDA for the treatment of stroke.
The breakthrough therapy designation stems from the provisions of FDA's Safety and Innovation Act. It is designed to expedite the development and regulatory review of drugs for treating serious diseases and addressing significant unmet medical needs.
Sanbexin sublingual tablets is a brain cytoprotective agent composed of edaravone and dexborneol, two active ingredients with synergistic anti-oxidant and anti-inflammatory effects, which can significantly reduce brain cell injury or impairment caused by AIS. Such unique sublingual formulation can quickly disintegrate once in contact with the saliva once place under the tongue and can be absorbed into the blood through the sublingual venous plexus, which is expected to increase the flexibility of stroke treatment. Sequential therapy consisting of the marketed Sanbexin concentrated solution for Injection. These two formulae enable patients to receive a complete course of treatment in and outside of the hospital.
On June 28, 2023, the new drug application (NDA) for Sanbexin sublingual tablets in China is accepted by the National Medical Products Administration.
The first indication is for the improvement of neurological symptoms, daily activities, and functional impairment due to AIS. Phase I clinical trials for Sanbexin sublingual tablets on healthy volunteers have been completed in the United States.
