Aspire Biopharma Files Provisional Patent Application for Industry-First Sublingual Formulation of Alprazolam - Generic Xanax(R) - for Rapid Anxiety Relief

Rhea-AI Summary

Aspire Biopharma (NASDAQ:ASBP) filed a provisional patent application for a first-ever sublingual powder formulation of alprazolam, aiming to improve bioavailability and accelerate onset versus oral tablets. The filing covers a sublingual delivery system designed to absorb alprazolam under the tongue to bypass first-pass metabolism and potentially shorten onset from about 30 minutes to minutes.

The company said it plans a Phase 1 clinical trial in mid-2026 and intends to pursue commercialization via the FDA 505(b)(2) pathway. Aspire framed this program as part of a broader pipeline of reformulated approved therapeutics targeting patients needing rapid relief or who have difficulty swallowing.

Positive

• Filed a provisional patent application for a novel sublingual alprazolam formulation
• Plans a Phase 1 clinical trial in mid-2026 to evaluate the new formulation
• Intends to use the 505(b)(2) regulatory pathway to commercialize reformulated therapeutics

Negative

• No clinical efficacy or safety data yet; human testing is planned for mid-2026
• Provisional patent filing is an early-step protection and does not guarantee issued patent rights
• Claims of much faster onset are unproven until pharmacokinetic and clinical results are available

News Market Reaction

-9.05%

15 alerts

-9.05% News Effect

+5.5% Peak Tracked

-17.6% Trough Tracked

-$591K Valuation Impact

$6M Market Cap

1.3x Rel. Volume

On the day this news was published, ASBP declined 9.05%, reflecting a notable negative market reaction. Argus tracked a peak move of +5.5% during that session. Argus tracked a trough of -17.6% from its starting point during tracking. Our momentum scanner triggered 15 alerts that day, indicating notable trading interest and price volatility. This price movement removed approximately $591K from the company's valuation, bringing the market cap to $6M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Prescription volume: 15.8 million prescriptions Usage ranking: 37th most commonly prescribed Phase 1 timing: Mid-2026 +2 more

5 metrics

Prescription volume 15.8 million prescriptions Alprazolam combined branded and generic prescriptions in 2023 (U.S.)

Usage ranking 37th most commonly prescribed Alprazolam’s rank among U.S. medications by prescriptions

Phase 1 timing Mid-2026 Planned Phase 1 clinical trial start for sublingual alprazolam

505(b)(2) pathway Section 505(b)(2) Intended FDA regulatory pathway for sublingual alprazolam and related products

Oral onset time 30 minutes or more Typical onset for traditional oral alprazolam tablets cited in article

Market Reality Check

Price: $1.81 Vol: Volume 1,164,580 is rough...

normal vol

$1.81 Last Close

Volume Volume 1,164,580 is roughly in line with the 1,259,766 20-day average (relative 0.92). normal

Technical Price at $2.21 is trading below the 200-day MA of $13.00 and 99.44% below the 52-week high.

Peers on Argus

ASBP gained 6.45% on the patent news, while peers showed mixed moves, with examp...

1 Down

ASBP gained 6.45% on the patent news, while peers showed mixed moves, with examples like CRIS at +4.79%, QTTB at +1.41%, and XCUR at -1.27%, suggesting a stock-specific reaction rather than a broad sector shift.

Historical Context

5 past events · Latest: Jan 14 (Negative)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 14	Reverse stock split	Negative	-26.4%	1-for-40 reverse split to address Nasdaq minimum bid price compliance.
Jan 07	Regulatory meeting	Positive	+19.6%	Supportive FDA pre-IND feedback for high-dose sublingual aspirin 505(b)(2) path.
Dec 18	Marketing partnership	Positive	+4.6%	Appointment of elite ultra-runner as BUZZ BOMB® global brand ambassador.
Dec 12	Nasdaq extension	Negative	-9.1%	Nasdaq panel extension with conditions to regain bid price and equity compliance.
Dec 04	Business update	Positive	+2.5%	Q3 update on sublingual aspirin bioavailability and BUZZ BOMB™ production ramp.

Pattern Detected

Recent ASBP news has mostly seen price moves align with the apparent news tone, with both positive regulatory updates and negative compliance events reflected in subsequent trading.

Recent Company History

Over the past months, Aspire Biopharma has balanced regulatory and strategic milestones with listing-compliance pressure. A 1-for-40 reverse split on Jan 16, 2026 followed Nasdaq bid-price challenges, while a positive pre-IND FDA meeting for its high-dose sublingual aspirin program on Jan 7, 2026 boosted shares. Earlier updates highlighted BUZZ BOMB® commercialization and a Q3 2025 business update focused on sublingual technology progress. Today’s alprazolam sublingual patent filing extends this same reformulation and delivery-platform narrative.

Market Pulse Summary

The stock moved -9.1% in the session following this news. A negative reaction despite positive-sound...

Analysis

The stock moved -9.1% in the session following this news. A negative reaction despite positive-sounding IP news would fit a profile where structural risks carry significant weight. Aspire’s recent reverse split and Nasdaq compliance pressures, along with going-concern language and heavy reliance on external financing in prior filings, have framed a cautious backdrop. In that context, traders may focus less on pipeline extensions like sublingual alprazolam and more on dilution, balance-sheet repair, and execution risk around upcoming clinical milestones.

Key Terms

sublingual, bioavailability, pharmacokinetic, api, +4 more

8 terms

sublingual medical

"New sublingual delivery system designed to enhance bioavailability"

Sublingual describes a way to take a drug or supplement by placing it under the tongue so active ingredients are absorbed through the thin tissue there directly into the bloodstream. Like taking a shortcut compared with swallowing a pill, this can produce faster effects, simpler dosing and sometimes more predictable delivery. Investors watch for sublingual formulations because they can affect a product’s market appeal, regulatory pathway, pricing and competitive positioning.

bioavailability medical

"delivery system designed to enhance bioavailability and speed of onset"

Bioavailability is the measure of how much and how quickly a substance, such as a medication or nutrient, enters the bloodstream and becomes available for use by the body. For investors, it matters because it influences how effectively a product works and how quickly results are seen, which can impact a company's success and the potential value of related investments. Think of it like how much of a medicine actually reaches your bloodstream after taking it—that determines how well it can do its job.

pharmacokinetic medical

"engineered to optimize the pharmacokinetic performance of alprazolam"

Pharmacokinetic describes how a drug moves through and leaves the body — how it is absorbed, spread to tissues, broken down and excreted — like tracking a package from pickup to delivery and disposal. For investors, these properties determine effective dose, safety risks, how often a medicine must be taken, and how reliably it works, which in turn influence clinical trial success, regulatory approval chances, production complexity and a drug’s commercial value.

api medical

"alprazolam, the active pharmaceutical ingredient (API) in the widely prescribed"

An API, or Application Programming Interface, is a set of rules that allows different software programs to communicate and work together smoothly, much like a waiter translating your order into the kitchen and then bringing your meal back. For investors, APIs are important because they enable real-time access to financial data, trading systems, and other digital services, making it easier to make informed decisions quickly and efficiently.

benzodiazepine medical

"standard-of-care generic benzodiazepine medication taken by millions"

A benzodiazepine is a type of prescription drug that calms the brain and body to relieve anxiety, help sleep, stop seizures or relax muscles — think of it as a temporary dimmer switch for overactive nerve signals. For investors, benzodiazepines matter because their demand, safety profile, regulatory restrictions, generic competition and litigation risk can directly affect drug makers’ sales, development plans and healthcare costs.

first-pass metabolism medical

"intended to bypass the gastrointestinal tract and first-pass metabolism"

First-pass metabolism is the process by which a drug taken by mouth is partly broken down in the gut wall and liver before it reaches the bloodstream, so less active medicine is available to the body. For investors, it matters because a high first-pass effect can force higher doses, different formulations or alternative delivery methods, increasing development cost, regulatory complexity and the commercial attractiveness of a drug—think of it as a filter that removes part of the product before it reaches customers.

505(b)(2) regulatory

"via the FDA's 505(b)(2) regulatory pathway"

A 505(b)(2) is an FDA drug approval pathway that lets a company win approval by relying partly on existing studies or published data instead of doing all new clinical trials. Think of it like building a renovated house using the original foundation: it can be faster and less costly than a full new-drug route, reducing development risk and expense. Investors care because it can speed market entry, lower capital needs, and offer opportunities for exclusivity or competitive advantage.

uspto regulatory

"filing of a new provisional patent application with the United States Patent and Trademark Office (USPTO)"

United States Patent and Trademark Office (USPTO) is the federal agency that reviews and issues patents for inventions and registers trademarks for brand names and logos. For investors, USPTO decisions act like a gatekeeper for a company’s legal right to exclude competitors — similar to a property deed for ideas and brands — which can protect revenue, support pricing power, and affect a company’s long‑term value and risk profile.

AI-generated analysis. Not financial advice.

• New sublingual delivery system designed to enhance bioavailability and speed of onset for major depressive and generalized anxiety disorders

• 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

• 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.

View the original press release on ACCESS Newswire

FAQ

What did Aspire Biopharma (ASBP) announce about a sublingual alprazolam formulation?

Aspire filed a provisional patent for a first-ever sublingual powder formulation of alprazolam designed to increase bioavailability and speed onset compared with oral tablets.

When is Aspire planning a Phase 1 trial for the ASBP sublingual alprazolam program?

Aspire plans to initiate a Phase 1 clinical trial in mid-2026 to evaluate the formulation's pharmacokinetics and safety.

How does Aspire say the sublingual alprazolam could affect time to relief compared to tablets?

The company claims the sublingual route could reduce onset from about 30 minutes to minutes by absorbing drug under the tongue and bypassing first-pass metabolism.

What regulatory pathway will Aspire use to commercialize the sublingual alprazolam (ASBP)?

Aspire intends to pursue the FDA 505(b)(2) pathway to seek approval for the reformulated alprazolam product.

Does the provisional patent filing mean Aspire has full patent protection for the ASBP formulation?

No; a provisional patent application secures a filing date but does not by itself confer an issued patent or long-term patent rights.

What investor-relevant milestones should shareholders watch for on ASBP's alprazolam program?

Key near-term milestones are the Phase 1 trial start and readouts, follow-up patent prosecution steps, and any regulatory interactions regarding the 505(b)(2) pathway.