Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096) has announced that the National Medical Products Administration (NMPA) has accepted for review its New Drug Application (NDA) for edaravone, borneol sublingual tablets, a treatment for acute ischemic stroke (AIS).
Edaravone, Borneol Sublingual Tablets: A Rapid-Acting Oral Preparation for AIS
The edaravone, borneol sublingual tablet is a solid oral preparation that contains both edaravone and borneol. This innovative formulation can be rapidly disintegrated under the tongue, allowing for absorption through the sublingual venous plexus and entry into the central nervous system. The tablets are designed to produce effects such as anti-inflammation, anti-free radicals, and protection of the blood-brain barrier, thereby reducing neuronal damage caused by stroke.
Phase III Data and Safety Profile
Phase III clinical data demonstrated that edaravone, borneol sublingual tablets significantly improved neurological recovery and the ability for patients with AIS to live independently after treatment, compared to a placebo. The study also showed a good safety profile, indicating the potential therapeutic benefits of this treatment approach for stroke patients.-Fineline Info & Tech
