Aspire Biopharma Files Provisional Patent Application for a Fast-Acting Sublingual Powder Formulation of Ondansetron (Generic Zofran(R))

New sublingual delivery system designed to provide more rapid relief from nausea caused by cancer medicines

Ondansetron, currently sold under the brand name Zofran^®, was the 53rd most commonly prescribed medication in the U.S. in 2023

Global ondansetron market size valued at approximately $1.4 billion in 2023

ESTERO, FL / ACCESS Newswire / February 12, 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 filing of a provisional patent application with the United States Patent and Trademark Office (USPTO). The application, titled “A Sublingual Powder Formulation of Ondansetron and Methods of Use Thereof,” marks the first-ever sublingual powder delivery system for ondansetron-the active ingredient in Zofran^®. Aspire’s formulation is designed to provide rapid relief for patients suffering from nausea and vomiting induced by chemotherapy, radiation, or surgery.

Redefining Nausea Relief: IV Speed Without the Needle

Ondansetron is currently limited by a roughly 30-minute delay when taken as a tablet. NIH

Aspire’s sublingual platform is engineered to deliver:

• Near-Instant Absorption: Bypasses the gastrointestinal tract and first-pass metabolism, potentially reducing onset of action from 30 minutes to just minutes.

• Clinical Comparability: Designed to mirror the speed of intravenous (IV) administration without the need for hospital-based injections or professional assistance.

• Patient Compliance: Specifically addresses the “unmet need” for patients who cannot swallow tablets due to severe emesis (vomiting) or gastric irritation.

Strategic Market Positioning

• Significant and Growing Utilization: Ondansetron was the 53rd most prescribed medication in the U.S. in 2023, with over 12.5 million prescriptions, according to ClinCalc.

• Market Growth: The global ondansetron market is projected to grow from $1.4 billion (2023) to $2.4 billion by 2032, driven by rising cancer incidences and expanded surgical procedures, according to DATAINTELO.

• Accelerated Approval Path: Aspire intends to utilize the FDA’s 505(b)(2) regulatory pathway, which leverages existing safety data to streamline clinical development and reduce time-to-market.

CEO Commentary

“This product candidate exemplifies the real-world clinical benefits of our sublingual drug delivery technology, providing fast relief when minutes matter most. By making existing, trusted medications work better and faster, we aim to provide a treatment solution for anyone facing the debilitating effects of acute nausea-from chemotherapy side effects to post-operative recovery,” said Kraig Higginson, Interim CEO of Aspire.

About Zofran^® and Ondansetron
Zofran^®, developed by GlaxoSmithKline, was approved by the FDA in 1991, with a generic version approved in July 2007. Ondansetron is used to prevent nausea and vomiting that is caused by cancer medicines (chemotherapy) or radiation therapy. It is also used to prevent nausea and vomiting that may occur after surgery. Ondansetron works in the stomach to block the signals to the brain that cause nausea and vomiting.

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

Aspire Biopharma Holdings, Inc.

Contact

PCG Advisory
Kevin McGrath
+1-646-418-7002
kevin@pcgadvisory.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 an 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; 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.

SOURCE: Aspire Biopharma Holdings, Inc.

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