Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096) announced that a Phase III clinical study for its edaravone, borneol sublingual tablets in acute ischemic stroke (AIS) has reached the pre-set efficacy endpoint. Preliminary analysis showed that, compared with a placebo, edaravone, borneol sublingual tablets could significantly improve the neurological recovery and independent living ability of patients with AIS after treatment, with a good safety profile.
Study Design and Results
The multicenter, randomized, double-blind, parallel, placebo-controlled Phase III study, designed to assess the efficacy and safety of the drug in AIS, enrolled upwards of 900 AIS patients with onset time ≤ 48 hours from nearly 40 centers in China. The study completed all patient treatment and visits in August, having completed patient enrollment in May 2022.
Product Mechanism and Future Plans
The edaravone, borneol sublingual tablet, a solid oral preparation, contains edaravone and borneol which can be rapidly disintegrated under the tongue, absorbed by the sublingual venous plexus, and enter the central nervous system to produce effects including anti-inflammation, anti-free radicals, and protection of the blood-brain barrier, thus reducing the neuronal damage caused by stroke. The product is expected to be sold alongside Simcere’s marketed edaravone, borneol concentrated solution for injection in the future.-Fineline Info & Tech
