Aspire Biopharma Advances FDA Discussions for Sublingual Aspirin

Aspire Biopharma Holdings, Inc. has submitted a Pre-IND meeting request and briefing package to the FDA. The company's lead product is a fast-acting, high-dose sublingual aspirin for treating suspected acute myocardial infarction. This submission marks a pivotal step towards potential FDA approval. The Pre-IND meeting seeks guidance on clinical strategy and confirms the proposed 505(b)(2) regulatory pathway.

Aspire's recent clinical trial results showed rapid platelet aggregation inhibition in under two minutes, significantly faster than traditional aspirin. The product demonstrated higher mean plasma concentrations of ASA, achieving notable superiority in action speed. It was also safe and well-tolerated.

The sublingual aspirin product aims to serve over 800,000 heart attack sufferers annually in the U.S. This development validates Aspire's advanced sublingual delivery platform, extending its potential to other drug programs.