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New sublingual delivery system designed to enhance bioavailability and speed of onset for major depressive and generalized anxiety disorders
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Alprazolam, sold under the brand name Xanax® among others, was the 37th most commonly prescribed medication in the United States, with more than 15.8 million combined branded and generic prescriptions in 2023
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Phase 1 clinical trial planned for mid-2026
ESTERO, FLORIDA / ACCESS Newswire / January 20, 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 new provisional patent application with the United States Patent and Trademark Office (USPTO). The application, titled “A Sublingual Powder Formulation of Alprazolam and Methods of Use Thereof,” covers the first-ever sublingual powder formulation of alprazolam, the active pharmaceutical ingredient (API) in the widely prescribed anti-anxiety medication Xanax®. This development represents a series of sublingual powder-based therapeutic alternatives the Company intends to commercialize via the FDA’s 505(b)(2) regulatory pathway. Aspire’s strategic pipeline focuses on reformulating approved therapeutics to address unmet needs where no powder alternatives currently exist.
Alprazolam is a standard-of-care generic benzodiazepine medication taken by millions of patients globally for the management of anxiety disorders and panic attacks. While effective, the traditional oral administration of alprazolam tablets typically requires considerable time to take effect, often 30 minutes or more – as the pill must pass through the digestive system and liver before entering the bloodstream.
Advancing Pharmacokinetic Performance With Aspire’s Sublingual Formulation
The patent filing seeks protection for Aspire’s advanced sublingual delivery system. This technology is engineered to optimize the pharmacokinetic performance of alprazolam by improving its absorption into the bloodstream, increasing bioavailability, and significantly accelerating the speed of onset compared to traditional oral tablets. Alprazolam is widely prescribed – ranking as the 37th most common medication in the U.S. with over 15.8 million prescriptions in 2023, combined branded and generic prescriptions, according to ClinCalc. Traditionally administered in tablet form, Aspire’s sublingual powder alprazolam is designed to provide a critical alternative for patients requiring rapid relief. By utilizing a unique sublingual mechanism of action, the Company’s formulation allows the drug to be absorbed rapidly under the tongue. This method is intended to bypass the gastrointestinal tract and first-pass metabolism, potentially reducing the onset of action from approximately half-an-hour to just minutes, offering a transformational solution for patients requiring immediate relief during acute episodes.
CEO Commentary
“Today marks another vital milestone as we introduce another unique formulation of a widely utilized therapeutic,” said Kraig Higginson, Interim CEO of Aspire. “We believe this dosage form could offer patients a faster onset of action, which is crucial for managing acute panic attacks or severe anxiety episodes where swift relief is essential. Furthermore, it provides a much-needed solution for adult patients who suffer from dysphagia or have difficulty swallowing traditional capsules and tablets. By applying our technology to alprazolam, we are not inventing a new drug; we are making an existing, proven drug potentially work faster and more effectively.”
Higginson added, “This initiative follows the recent positive FDA response regarding our high-dose aspirin candidate and aligns with our broader strategy to expand our pipeline of 505(b)(2) branded products.”
About Alprazolam
Alprazolam is a benzodiazepine indicated for the management of generalized anxiety disorder (GAD), panic disorders, and symptoms of depression. While the first generic immediate-release tablets were FDA-approved in 1993, the market has lacked a fast-acting powder formulation. Aspire’s 505(b)(2) strategy aims to bridge this gap by leveraging the established safety profile of alprazolam while introducing a superior delivery mechanism.
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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