Aspire Biopharma Files Provisional Patent Application for a Fast-Acting Sublingual Powder Formulation of Meclizine (Generic Dramamine(R))
Rhea-AI Summary
Aspire Biopharma (NASDAQ:ASBP) filed a provisional patent application for a proprietary sublingual powder formulation of meclizine on February 17, 2026. The formulation targets rapid-onset relief, aiming to cut typical oral onset from about 60 minutes to minutes and to support a 505(b)(2) regulatory path.
The company cites ~4.09 million U.S. prescriptions in 2023 and a $450M global meclizine market, projecting growth to $650M by 2032.
Positive
- Provisional patent filed for sublingual meclizine (USPTO filing)
- First-ever sublingual powder delivery claimed for meclizine
- Targets rapid onset—engineered to reduce action from ~60 minutes to minutes
- Plans 505(b)(2) pathway to potentially accelerate clinical development
Negative
- Provisional filing does not guarantee patent grant or enforceable rights
- No clinical efficacy data published yet to confirm faster onset or safety
- Market projection to $650M by 2032 is long-term and not guaranteed
Key Figures
Market Reality Check
Peers on Argus
Momentum scanner data flags ASBP moving opposite its biotech peers: the target was marked as down while peers like FBLG and XCUR showed moves up. Broader sector peers in the same industry show mixed single‑day changes, suggesting the move is stock‑specific to Aspire’s Meclizine patent news rather than a coordinated biotech rotation.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Feb 13 | Board appointment | Positive | +9.2% | New director with 25+ years capital markets experience joins board. |
| Feb 12 | Patent filing | Positive | -3.0% | Provisional patent for fast-acting sublingual ondansetron formulation. |
| Feb 11 | Private placement | Negative | -4.3% | Up to $21M Series A preferred private placement to strengthen balance sheet. |
| Feb 10 | Nasdaq compliance | Positive | -2.1% | Regained compliance with Nasdaq minimum $1.00 bid price rule. |
| Feb 05 | Product showcasing | Positive | -14.8% | Subsidiary showcasing BUZZ BOMB sublingual caffeine at industry summit. |
Recent Aspire news has often seen selling into positive announcements, with 3 divergences vs. 2 alignments between news tone and next‑day price moves.
Over the last two weeks, Aspire reported multiple milestones, including Nasdaq bid-price compliance on Feb 10, a $21.0M private placement, and patent work on a sublingual ondansetron formulation. Despite these strategic and financing updates, several positive or neutral items (compliance, product showcasing, new formulation) saw negative next‑day reactions. Today’s Meclizine patent filing continues the theme of leveraging Aspire’s sublingual platform across established drugs.
Market Pulse Summary
This announcement outlines Aspire’s strategy to apply its sublingual powder platform to Meclizine, targeting faster relief in a $450M global market projected to reach $650M by 2032. It follows recent financings and Nasdaq compliance steps, highlighting a shift toward reformulating widely used therapies. Investors may watch for clinical data validating the reduced onset versus the current 60-minute standard, regulatory progress under the 505(b)(2) pathway, and how this effort complements Aspire’s broader sublingual portfolio.
Key Terms
sublingual medical
first-pass metabolism medical
antiemetic medical
vestibular disorders medical
505(b)(2) regulatory pathway regulatory
AI-generated analysis. Not financial advice.
New delivery system targets rapid-onset relief for motion sickness and vertigo, modernizing the
Meclizine was the top-prescribed antiemetic/antivertigo agent in 2023, with approximately 4.09 million prescriptions.
ESTERO, FL / ACCESS Newswire / February 17, 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 U.S. Patent and Trademark Office (USPTO) for its proprietary sublingual powder formulation of Meclizine.
The application, titled "A Sublingual Powder Formulation of Meclizine and Methods of Use Thereof," represents a significant leap in antiemetic therapy. By introducing the first-ever sublingual powder delivery system for Meclizine, Aspire aims to eliminate the traditional "waiting period" associated with oral tablets, providing near-instant relief for nausea, vomiting, and vertigo.
Solving the One-Hour Delay
While Meclizine remains the gold standard for vestibular disorders, traditional tablet forms are hindered by a slow onset of action. Standard oral administration typically requires one hour to begin working and up to three hours to reach peak plasma levels. Aspire's sublingual platform is engineered to redefine this standard through:
Rapid Systemic Entry: By bypassing the gastrointestinal tract and first-pass metabolism, the formulation is designed to reduce the onset of action from 60 minutes to mere minutes. NIH
Enhanced Patient Compliance: The powder format provides a critical solution for patients suffering from severe emesis (vomiting) or gastric irritation who cannot tolerate swallowing traditional pills.
Strategic Market Opportunity
As the top-prescribed antiemetic of 2023 with over 4.09 million prescriptions in the U.S. alone, Meclizine represents a robust and growing market. ClinCalc
Market Expansion: The global Meclizine market, valued at
Streamlined Regulatory Path: Aspire intends to pursue the FDA's 505(b)(2) regulatory pathway. This strategy leverages existing safety data of the reference drug to significantly accelerate clinical development and reduce time-to-market.
CEO Commentary
"This filing marks a pivotal milestone in our mission to modernize essential medications," said Kraig Higginson, Interim CEO of Aspire. "For millions suffering from the sudden onset of vertigo or motion sickness, waiting an hour for a tablet to kick in is simply not an option. Our sublingual technology is designed to deliver the relief patients need, exactly when they need it."
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.
View the original press release on ACCESS Newswire
FAQ
What did Aspire Biopharma (ASBP) file with the USPTO on February 17, 2026?
How fast does Aspire claim the ASBP sublingual meclizine will act compared with tablets?
What regulatory route will ASBP pursue for the new sublingual meclizine formulation?
How large is the meclizine market cited by Aspire and why does it matter for ASBP?
What investor risks are associated with Aspire's ASBP provisional patent and claims?
