Aspire Biopharma Submits Pre-IND Meeting Request and Briefing Package to U.S. FDA for Sublingual Aspirin Product for Treatment of Suspected Acute Myocardial Infarction (Heart Attack)

ESTERO, FLORIDA / ACCESS Newswire / December 2, 2025 / Aspire Biopharma Holdings, Inc. (NASDAQ:ASBP) ("Aspire" or the "Company"), a developer of a multi-faceted patent-pending drug delivery technology, is pleased to announce that on November 3, 2025, it submitted its Pre-IND meeting request and briefing package to the U.S. Food and Drug Administration (FDA). The submission concerns the Company's lead product candidate, a fast-acting, high-dose sublingual aspirin formulation for the treatment of suspected acute myocardial infarction (AMI) and represents a significant milestone on the path to potential FDA approval.

The Pre-IND meeting initiates formal dialogue with the FDA and is intended to gain agency guidance on the clinical development strategy and confirm the proposed 505(b)(2) regulatory pathway for Aspire's sublingual aspirin. Gaining this clarity is a critical step toward the Company's goal of submitting a New Drug Application (NDA).

"Our clinical data is not just promising; it's a breakthrough in MCI treatment. We demonstrated that our sublingual formulation begins to inhibit platelet aggregation in under two minutes, acting approximately four to five times as fast as chewed aspirin," said Kraig Higginson, Interim CEO of Aspire Biopharma. "This rapid action, confirmed with a statistical significance of p

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