FDA Fast-Tracks Sublingual Therapy for Acute Ischemic Stroke Following Promising Trial Results

The FDA has granted Breakthrough Therapy designation to Sanbexin, a sublingual tablet containing edaravone and dexborneol, for the treatment of acute ischemic stroke (AIS). This decision comes in light of strong data from the TASTE-SL phase 3 clinical trial, where Sanbexin demonstrated a significant improvement in functional recovery for stroke patients compared to placebo. With this designation, the development of Sanbexin will be accelerated, potentially expanding the treatment landscape for AIS.

Sanbexin stands out due to its sublingual administration, offering the flexibility for use in settings outside of hospitals. This could enable faster intervention in stroke cases, where every minute counts in preventing long-term damage. In the TASTE-SL trial, which enrolled 914 participants, 64.4% of those treated with Sanbexin achieved favorable scores on the modified Rankin Scale (mRS) at 90 days post-treatment, compared to 54.7% in the placebo group. This difference (P=.003) underscores the drug's potential in reducing disability following stroke. Additionally, the rates of adverse events were nearly identical between the Sanbexin and placebo groups, indicating a similar safety profile.

This breakthrough could be transformative for healthcare providers, as AIS remains one of the leading causes of disability worldwide. Current stroke treatments are limited to hospital settings, but Sanbexin’s sublingual formulation could change that by allowing for quicker, more accessible treatment outside traditional environments. With the Breakthrough Therapy designation, Sanbexin’s path toward clinical use has been fast-tracked, presenting a new opportunity to improve outcomes for stroke patients.