Sanbexin Sublingual Tablets Receive FDA Breakthrough Therapy Designation
Simcere Pharmaceuticals Group Ltd. has announced that its Sanbexin Sublingual Tablets, containing edaravone and dexborneol, have been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for treating Acute Ischemic Stroke (AIS).
This designation aims to speed up the development and review of drugs for serious conditions with unmet medical needs.
The decision is based on results from a previous clinical study, where the sublingual tablets showed significant improvements in efficacy. Data from a multicentre, Phase III clinical trial in China, which was randomised, double-blind, and placebo-controlled, demonstrated that the tablets significantly enhanced neurological recovery and patients' ability to live independently after an AIS, compared to the placebo.
Sanbexin sublingual tablets are the first drug for stroke treatment to receive the FDA’s Breakthrough Therapy designation. Sanbexin is a brain cytoprotective agent, combining edaravone and dexborneol, which together have antioxidant and anti-inflammatory effects that help reduce brain cell damage caused by AIS.
The sublingual formulation dissolves quickly in the mouth and is absorbed into the bloodstream, potentially making stroke treatment more adaptable. This formulation complements the existing Sanbexin injection solution, allowing patients to complete a full course of treatment both in the hospital and at home.
The first indication for the drug is aimed at improving neurological symptoms, daily functioning, and reducing impairment from AIS. Phase I clinical trials of the sublingual tablets in healthy volunteers have already been completed in the United States.
