China-based Simcere Pharmaceutical Group Limited (HKG: 2096) has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its edaravone and borneol sublingual tablets. These tablets are designed to improve neurological symptoms, daily living activities, and functional impairments caused by acute ischemic stroke (AIS).
Rapid Dissolution and Absorption for Swift AIS Treatment
The edaravone and borneol sublingual tablet, a solid oral preparation, contains both edaravone and borneol, which can rapidly disintegrate under the tongue. This allows for absorption by the sublingual venous plexus and swift entry into the central nervous system. The drug’s effects include anti-inflammation, anti-free radicals, and protection of the blood-brain barrier, thereby reducing neuronal damage caused by stroke. The injectable dosage form of the drug was approved for marketing in 2020, and the sublingual tablets were co-developed by Neurodawn Pharmaceutical Co., Ltd.
Phase III TASTE-SL Study Results
The Phase III TASTE-SL study demonstrated that edaravone and borneol sublingual tablets can significantly reduce brain cell damage caused by AIS. On the 90th day after treatment, the proportion of patients with good functional outcomes (mRS at 0-1, indicating restoration of independent living function) was significantly higher in the treatment group compared to the placebo group (64.4% vs 54.7%). The study also showed that the drug has a good safety profile.-Fineline Info & Tech
