HONG KONG—Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096) has announced that it has received Breakthrough Therapy Designation (BTD) from the US Food and Drug Administration (FDA) for its edaravone, borneol sublingual tablet, intended for the treatment of acute ischemic stroke (AIS).
The edaravone, borneol sublingual tablet is a solid oral preparation that contains both edaravone and borneol, designed to rapidly disintegrate under the tongue. This allows for absorption through the sublingual venous plexus and entry into the central nervous system, where it can exert effects such as anti-inflammation, anti-oxidative activity, and protection of the blood-brain barrier. These actions are expected to mitigate the neuronal damage associated with stroke.
The product is anticipated to be used in combination with the already listed edaravone, borneol injection, offering a sequential therapy approach for patients. This combination therapy has the potential to enhance treatment outcomes and provide a more comprehensive treatment option for stroke patients.
Currently awaiting regulatory approval in China, the product has successfully completed a Phase I study in healthy subjects in the US, marking a significant step towards its potential launch in the global market. The FDA’s BTD highlights the drug’s potential to address an unmet medical need and offers an expedited pathway for development and review. – Flcube.com
