Aspire Biopharma Initiates Phase 1 Trial for High-Dose Aspirin

Aspire Biopharma Holdings, Inc. has commenced a Phase 1 clinical trial for its new oral transmucosal high-dose aspirin formulation. This study aims to evaluate the safety, pharmacokinetics, and pharmacodynamics of the product. The trial, set in a single clinical location, targets enrolling six to eight participants in April. Initial results are anticipated by the end of the second quarter.

The study compares the pharmacokinetic and pharmacodynamic responses of 162.5 mg sublingual aspirin powder in healthy adults versus the same dose of oral aspirin. Aspire will use the results to support a request for FDA "fast track" approval, aiming to facilitate rapid approval for treating suspected acute myocardial infarction.

The innovation could benefit patients with its fast absorption, potentially offering a quick response during cardiovascular emergencies while minimizing gastrointestinal side effects. Aspire is strategically approaching the FDA to discuss further development plans.