Aspire Biopharma Announces Top-Line Data From Crossover Bioavailability Trial To Assess Safety, Tolerability, PK And PD Of Aspire's New Sublingual Aspirin Product Compared To Chewed Uncoated Aspirin Tablets In Healthy Adults

Benzinga · 08/18/2025 12:33

According to the NIH, Acute myocardial infarction (AMI) is a major cause of death, affecting nearly 3 million Americans each year and resulting in over a million deaths

Trial demonstrates dramatically higher and more rapid therapeutic impact compared to standard chewed aspirin tablets in clinical trial

Aspire's sublingual aspirin was safe and well-tolerated

Aspire plans to review clinical trial results with the FDA to enable a potential regulatory submission for accelerated approval

ESTERO, FL / ACCESS Newswire / August 18, 2025 / Aspire Biopharma Holdings, Inc. (NASDAQ:ASBP) ("Aspire" or the "Company"), developer of a multi-faceted patent-pending drug delivery technology, today announced positive top-line data from its recent randomized, crossover bioavailability trial to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of Aspire's investigational new sublingual aspirin product compared to chewed uncoated aspirin tablets in healthy adults. Pharmacokinetics is the term that describes the four stages of absorption, distribution, metabolism, and excretion of drugs. Pharmacodynamics (sometimes described as what a drug does to the body) is the study of the biochemical, physiologic, and molecular effects of drugs on the body.

The Aspire sublingual aspirin product produced higher and more rapid mean plasma concentrations of acetylsalicylic acid (ASA, the active antiplatelet form of aspirin) compared to chewed aspirin tablets (p<0.05). Significant improvement in absorption was evident within five minutes and continued throughout the first half-hour after dosing. Higher and more rapid mean plasma concentrations imply that the drug is absorbed quickly and reaches a higher concentration in the bloodstream shortly after administration. The product was also safe and well-tolerated by patients, and no adverse events were reported.