Aspire Biopharma Initiates Phase 1 Trial for Fast-Acting High-Dose Aspirin Formulation, Aiming for Accelerated FDA Approval

Reuters
20 May
Aspire Biopharma Initiates Phase 1 Trial for Fast-Acting High-Dose Aspirin Formulation, Aiming for Accelerated FDA Approval

Aspire Biopharma Holdings Inc., headquartered in Humacao, Puerto Rico, has announced the dosing of the first patient in its Phase 1 clinical trial for an oral transmucosal fast-acting high-dose aspirin formulation. This trial is a single-center study conducted in the United States to evaluate the safety, pharmacokinetics, and pharmacodynamics of the company's lead therapeutic candidate. The trial involves healthy adult volunteers receiving a sublingual dose of 162.5 mg aspirin powder or granules, compared to control subjects given the same dose of oral aspirin. The primary outcome measure of the study will be plasma acetylsalicylic acid concentration over time. Aspire anticipates disclosing topline data from the trial early in the third quarter of 2025, which could potentially support accelerated approval, pending FDA review.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Aspire Biopharma Holdings Inc. published the original content used to generate this news brief via ACCESS Newswire (Ref. ID: 1029564) on May 20, 2025, and is solely responsible for the information contained therein.

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