FDA feedback supports 505(b)(2) filing in H2 2026; No additional studies required beyond current planned 32-subject clinical trial
ESTERO, FL / ACCESS Newswire / January 7, 2026 / Aspire Biopharma Holdings, Inc. (Nasdaq:ASBP) (“Aspire” or the “Company”), a biopharmaceutical company developing multi-faceted patent-pending drug delivery technology, today announced the successful outcome of a Type B pre-Investigational New Drug (IND) meeting with the U.S. Food and Drug Administration (FDA). The meeting provided a clear regulatory roadmap for the Company’s investigational new drug, acetylsalicylic acid 162 mg sublingual powder (OTASA), designed for the emergency treatment of suspected acute myocardial infarction (heart attack).
The FDA’s written responses provide the necessary guidance to finalize the Company’s clinical and regulatory development strategy. Based on FDA’s feedback, Aspire anticipates completing a currently planned multicenter crossover clinical trial and then submitting a Section 505(b)(2) New Drug Application. The clinical trial will evaluate serum thromboxane B2 (TxB2) inhibition in 32 healthy volunteers, comparing OTASA (162 mg) against the current standard of care-two chewed 81 mg aspirin tablets.
“The FDA’s constructive feedback validates our development path and brings us one step closer to providing a faster-acting intervention for heart attack patients,” said Kraig Higginson, Interim CEO of Aspire. “Aligning with the Agency on our clinical requirements significantly de-risks our timeline and we believe the FDA’s response leaves the door open for Aspire to obtain breakthrough therapy status for our OTASA product. We believe OTASA has the potential to become the market-leading emergency treatment, and this regulatory clarity is a vital milestone as we engage in active discussions with potential commercial partners.”
Clinical Data Highlights
The pre-IND submission was supported by data from a pilot, proof-of-concept clinical trial demonstrating:
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Rapid Absorption: OTASA produced higher and faster mean plasma concentrations of acetylsalicylic acid (ASA) compared to chewed aspirin tablets.
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Rapid Platelet Inhibition: The sublingual formulation inhibited serum TxB2-a key biomarker for platelet aggregation-within the first two minutes of administration.
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Safety Profile: In initial evaluations, the product was safe and well-tolerated, with no reported adverse events.
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; Aspire’s acetylsalicylic acid sublingual powder, 162 mg (OTASA) is an investigational new drug and has not been approved for marketing for any indication, our limited operating history and our ability to obtain additional funding for operations and to complete the development and commercialization of our drug candidates; that the Company will be able to meet the deadlines or conditions imposed by the Hearings Panel or regain compliance with all applicable requirements for continued listing, 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:
PCG Advisory
Kevin McGrath
+1-646-418-7002
kevin@pcgadvisory.com
SOURCE: Aspire Biopharma Holdings, Inc.
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