Aspire Biopharma Announces Breakthrough Clinical Trial Results for Sublingual Aspirin, Aiming for Accelerated FDA Approval
Reuters
Sep 03
<a href="https://laohu8.com/S/ASBPW">Aspire Biopharma</a> Announces Breakthrough Clinical Trial Results for Sublingual Aspirin, Aiming for Accelerated FDA Approval
Aspire Biopharma Holdings, Inc. (NASDAQ:ASBP) has announced positive final results from its randomized, crossover bioavailability trial involving its investigational new sublingual aspirin product. The study assessed the safety, tolerability, pharmacokinetics, and pharmacodynamics of the sublingual aspirin compared to chewed uncoated aspirin tablets. Results demonstrated that the sublingual aspirin produced higher and more rapid mean plasma concentrations of acetylsalicylic acid, indicating faster inhibition of serum thromboxane B2 (TxB2), a biomarker for platelet aggregation. This rapid action is crucial during suspected heart attacks to prevent permanent heart muscle damage. Aspire plans to review these results with the U.S. Food and Drug Administration (FDA) for a potential regulatory submission for accelerated approval in the third quarter of 2025.
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