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)
Rhea-AI Summary
Aspire Biopharma (NASDAQ:ASBP) said it submitted a Pre-IND meeting request and briefing package on November 3, 2025 to the U.S. FDA for its lead product: a fast-acting, high-dose sublingual aspirin for suspected acute myocardial infarction (AMI).
Company-reported trial results claim the formulation begins to inhibit platelet aggregation in under two minutes, acting 4–5× faster than chewed aspirin, with higher mean plasma ASA and reduced serum TxB2 within two minutes; the product was described as safe and well-tolerated. Aspire intends to pursue a 505(b)(2) regulatory pathway toward a future NDA.
Positive
- Pre-IND submission dated November 3, 2025
- Onset of platelet inhibition in under 2 minutes
- Pharmacologic action reported 4–5× faster than chewed aspirin
- Higher mean plasma ASA and reduced serum TxB2 within 2 minutes
- 505(b)(2) pathway targeted to streamline development
- Product described as safe and well-tolerated in trial
Negative
- Regulatory status: Pre-IND only; no FDA approval or NDA submitted yet
- Press release omits complete statistical details (exact p‑values not provided)
Insights
Pre‑IND submission and claimed rapid pharmacology are a clear regulatory milestone with potentially positive clinical and programmatic implications.
Aspire Biopharma has requested a formal Pre‑IND meeting with the FDA (submission dated
The company reports clinical results showing faster ASA plasma levels and earlier reduction in serum TxB2 versus chewed aspirin and states statistical significance and acceptable tolerability. The writeup omits exact p‑values and full data details, so the claim of superior onset and safety must be treated as an asserted result pending review of the complete dataset and FDA feedback; the Pre‑IND will likely focus on bridging pharmacology, dosing, and safety data to support a 505(b)(2) approach.
Near‑term dependencies include the FDA's Pre‑IND response, any requested additional pharmacokinetic/pharmacodynamic or safety studies, and the company providing full trial datasets. Watch for formal FDA meeting minutes or agreed written guidance and any clear requests for additional trials or endpoints over the next 3–12 months (
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<0.02, represents a clear and potentially life-saving advantage over the current standard of care. In a heart attack, every second saved translates to preserved heart muscle. We are eager to present this compelling evidence to the FDA and define an efficient path to bring this superior treatment to patients."
Aspire's confidence is rooted in the breakthrough final results of its recent clinical trial. The study showed that Aspire's investigational product produced significantly higher and more rapid mean plasma concentrations of acetylsalicylic acid (ASA), the active form of aspirin, compared to chewed aspirin tablets (p<0.05). This was demonstrated clearly in the recent trial by the lowered levels of serum thromboxane B2 (TxB2), a key biomarker for reduced platelet accumulation, within the first two minutes after dosing (p<0.02) with Aspire's sublingual aspirin, acting approximately four to five times faster than chewed conventional aspirin. This rapid pharmacological action demonstrates a clear and clinically meaningful superiority over the current standard of care.
The product was also observed to be safe and well-tolerated. These results underscore the potential for Aspire's sublingual aspirin to provide a more rapid and reliable treatment for the 800,000+ people in the U.S. who suffer a heart attack each year.
The Company intends to pursue a 505(b)(2) regulatory pathway for its sublingual aspirin product. This streamlined pathway allows the FDA to consider data from previous studies on an already-approved drug, such as aspirin, which can potentially reduce the time and cost of development.
This milestone for the lead aspirin program also serves as a key validation of Aspire's versatile sublingual delivery platform, which is being applied to a pipeline of other high-value programs.
About Aspire Biopharma Holdings, Inc.
Aspire Biopharma has developed a patent-pending sublingual delivery technology that can deliver drugs to the body rapidly and precisely. This technology offers the potential to improve effectiveness and reduce side effects by going directly to the bloodstream and avoiding the gastrointestinal tract. Aspire Biopharma's delivery technology can be applied to many different active pharmaceutical ingredients (APIs) and other bioactive substances, spanning both small and large molecule therapeutics, nutraceuticals and supplements.
For more information, please visit www.aspirebiolabs.com
Safe Harbor Statement
This press release contains "forward-looking statements" within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended, which are intended to be covered by the "safe harbor" provisions created by those laws. Aspire's forward-looking statements include, but are not limited to, statements regarding our or our management team's expectations, hopes, beliefs, intentions or strategies regarding our future operations. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words "anticipate," "believe," "contemplate," "continue," "estimate," "expect," "intends," "may," "might," "plan," "possible," "potential," "predict," "project," "should," "will," "would," and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements represent our views as of the date of this press release and involve a number of judgments, risks and uncertainties. We anticipate that subsequent events and developments will cause our views to change. We undertake no obligation to update forward-looking statements to reflect events or circumstances after the date they were made, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. Accordingly, forward-looking statements should not be relied upon as representing our views as of any subsequent date. As a result of a number of known and unknown risks and uncertainties, our actual results or performance may be materially different from those expressed or implied by these forward-looking statements. Some factors that could cause actual results to differ include general market conditions, whether clinical trials demonstrate the efficacy and safety of our drug candidates to the satisfaction of regulatory authorities, or do not otherwise produce positive results which may cause us to incur additional costs or experience delays in completing, or ultimately be unable to complete the development and commercialization of our drug candidates; the clinical results for our drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; our ability to achieve commercial success for our drug candidates, if approved; our limited operating history and our ability to obtain additional funding for operations and to complete the development and commercialization of our drug candidates; and other risks and uncertainties set forth in "Risk Factors" in our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q. In addition, statements that "we believe" and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this press release, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and you are cautioned not to rely unduly upon these statements. All information in this press release is as of the date of this press release. The information contained in any website referenced herein is not, and shall not be deemed to be, part of or incorporated into this press release.
Aspire Biopharma Holdings, Inc.
Contact
Brett Maas
Hayden IR: (646) 536-7331
brett@haydenir.com
James Carbonara
Hayden IR: (646)-755-7412
james@haydenir.com
SOURCE: Aspire Biopharma Holdings, Inc.
View the original press release on ACCESS Newswire
FAQ
What did Aspire Biopharma (ASBP) file with the FDA on November 3, 2025?
How quickly did Aspire report its sublingual aspirin works in the trial?
What regulatory pathway is Aspire targeting for ASBP's sublingual aspirin?
Did Aspire report safety data for the sublingual aspirin in the trial?
What clinical biomarkers did Aspire cite to support efficacy for ASBP's product?
Does Aspire's November 2025 filing mean FDA approval is imminent for ASBP?
