Practical NeurologyFDA Grants Breakthrough Therapy Designation to Sublingual Treatment for Acute Ischemic Stroke

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The FDA has granted Breakthrough Therapy designation to Sanbexin, a novel sublingual treatment for acute ischemic stroke (AIS). This designation, based on positive phase 3 clinical trial results, could expedite the development and review process for this promising therapy. Sanbexin’s unique formulation and administration route may offer new options for AIS treatment outside hospital settings.

Key Points:

• Sanbexin, a combination of edaravone and dexborneol, received FDA Breakthrough Therapy designation for AIS treatment.
• The TASTE-SL phase 3 trial demonstrated statistically significant improvements in functional outcomes for Sanbexin vs placebo.
• 64.4% of Sanbexin-treated patients achieved a modified Rankin Scale score ≤1 at day 90, compared to 54.7% in the placebo group.
• Sanbexin’s sublingual administration allows for flexible treatment outside the hospital setting.
• The drug’s synergistic antioxidant and anti-inflammatory effects may reduce impairment after AIS.
• Sanbexin showed consistent effects across multiple subgroups in the trial.
• Adverse event rates were similar between Sanbexin (89.8%) and placebo (90.1%) groups.

More than 12 million people worldwide will have their first stroke this year and 6.5 million will die as a result. (World Stroke Organization)

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