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Abuse-deterrent fentanyl patch at Nutriband (NASDAQ: NTRB) targets $80M-$200M

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(High)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Nutriband Inc. filed a current report to share a press release under Regulation FD. The company has selected a commercial worldwide brand name candidate for its lead product, an abuse-deterrent fentanyl transdermal patch built on its AVERSA™ technology, and will submit the name and labeling to the FDA and other regulators for review and approval. The name is also being filed with the U.S. Patent and Trademark Office to secure trademark protection. Nutriband cites a market analysis suggesting its abuse-deterrent fentanyl transdermal system could reach peak annual U.S. sales between $80 million and $200 million, while it continues development for major global markets and highlights AVERSA’s patent coverage across 46 countries.

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Item 7.01 Regulation FD Disclosure Disclosure
Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Peak annual U.S. sales potential $80 million-$200 million Market analysis for abuse-deterrent fentanyl transdermal system
Patent countries 46 countries AVERSA abuse-deterrent transdermal technology IP portfolio
Brand Institute global drug name approval share 75% Share of drug name approvals globally over 20+ years
Brand Institute FDA name approvals in 2024 87% Portion of FDA-approved names in 2024 attributed to Brand Institute
Regulation FD Disclosure regulatory
"Item 7.01. Regulation FD Disclosure. See attached press release"
abuse deterrent fentanyl transdermal system medical
"lead product, an abuse deterrent fentanyl transdermal system"
AVERSA™ abuse-deterrent transdermal technology medical
"This product utilizes Nutriband’s AVERSA™ abuse deterrent transdermal technology"
transdermal patches medical
"incorporate aversive agents into transdermal patches to prevent the abuse"
forward-looking statements regulatory
"constitute “forward-looking statements” within the meaning of the Private Securities"
Forward-looking statements are predictions or plans that companies share about what they expect to happen in the future, like estimating sales or profits. They matter because they help investors understand a company's outlook, but since they are based on guesses and assumptions, they can sometimes be wrong.
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SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported); March 30, 2026

 

Nutriband Inc.

 

Nevada   000-40854   81-1118176

(State or Other Jurisdiction

of Incorporation)

  (Commission File Number)  

(I.R.S. Employer

Identification No.)

 

121 S. Orange Ave. Suite 1500

Orlando, Florida

  32801
(Address of Principal Executive Offices)   (Zip Code)

 

(407) 377-6695

Registrant’s Telephone Number, Including Area Code

 

 

(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). 

 

Emerging growth company 

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. 

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading Symbol(s)   Name of each exchange on which registered
Common Stock   NTRB   The Nasdaq Stock Market LLC 
Warrants   NTRBW   The Nasdaq Stock Market LLC

 

 

 

 

 

 

Item 7.01. Regulation FD Disclosure.

 

See attached press release dated March 30, 2026.

 

Item 9.01 Financial Statements and Exhibits

 

(d) Exhibits

 

The following exhibits are being filed with this Current Report on Form 8-K:

 

99.1   Press Release issued March 30, 2026.
104   Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

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SIGNATURES

 

PURSUANT TO THE REQUIREMENTS OF THE SECURITIES EXCHANGE ACT OF 1934, THE REGISTRANT HAS DULY CAUSED THIS REPORT TO BE SIGNED ON ITS BEHALF BY THE UNDERSIGNED THEREUNTO DULY AUTHORIZED.

 

  NUTRIBAND, INC.
     
Date: April 7, 2026 By: /s/ Gareth Sheridan
    R: Gareth Sheridan
    Chief Executive Officer

 

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Exhibit 99.1

 

NUTRIBAND SELECTS COMMERCIAL BRAND NAME FOR ITS ABUSE DETERRENT FENTANYL PATCH

 

Nutriband has selected the commercial worldwide brand name for its lead product, an abuse deterrent fentanyl transdermal system, and will submit to the FDA for approval per FDA Guidance.

 

Nutriband partnered with Brand Institute, Inc, the global leader in pharmaceutical and healthcare-related brand name and identity development.

 

ORLANDO, FL / ACCESSWIRE / March 30, 2026 / Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW), a company engaged in the development of prescription transdermal pharmaceutical products, today announced that it has selected the commercial worldwide brand name candidate for its lead product, an abuse deterrent fentanyl transdermal system. The proposed brand name and product labeling will be submitted to the FDA and other international regulatory agencies for review and approval. In addition, the selected name is being submitted to the United States Patent and Trademark Office for trademark registration and to secure full intellectual property rights in the United States and internationally.

 

The company engaged Brand Institute, Inc, the global leader in pharmaceutical and healthcare-related brand name and identity development services to develop the worldwide commercial brand name and visual identity for the product. This product utilizes Nutriband’s AVERSA™ abuse deterrent transdermal technology and has the potential to be the world’s first abuse-deterrent patch designed to deter the abuse and misuse and reduce the risk of accidental exposure of transdermal fentanyl.

 

Nutriband’s abuse deterrent fentanyl transdermal system has the potential to reach peak annual US sales of $80 million to $200 million.1 While initially concentrating on the US market, the unmet medical need for adequate pain management is a global problem, and the product is in development for all major medical markets worldwide.

 

Developing a proprietary brand name for a prescription drug product is a critical element in drug product development because the end users (doctors, pharmacists, patients) must be able to easily distinguish a proprietary name from other drug names that are phonetically similar (sound-alike names) or similar in their spelling or appearance (look-alike names). In addition, if the drug name is otherwise confusing or misleading, the patient might receive the wrong product and the subsequent medication error could lead to significant harm to the patient.

 

 

 

Brand Institute has been leading the market for over 20 years with a 75% share of drug name approvals globally, including 87% of FDA approved names in 2024. In addition, Brand Institute has been responsible for many of the opioid chronic pain product brand names and specifically a majority of the abuse deterrent opioid product brand names approved by FDA for sale in the United States.

 

Drug Safety Institute (DSI), a wholly owned regulatory subsidiary of Brand Institute, will provide regulatory services, solutions and support on the project. DSI is led by former officials from US Food & Drug Administration (FDA), European Medicines Agency (EMA), Health Canada (HC), United States Adopted Name Council (USAN), and World Health Organization (WHO) who co-authored the naming guidance documents while with their former respective agencies.

 

Nutriband’s AVERSA™ abuse-deterrent technology is utilized to incorporate aversive agents into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential including opioids and stimulants. The AVERSA™ abuse deterrent technology is protected by a broad international intellectual property portfolio with patents issued in 46 countries including the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia.

 

Health Advances Aversa Fentanyl market analysis report 2022

 

About AVERSA™ Abuse-Deterrent Transdermal Technology

 

Nutriband’s AVERSA™ abuse-deterrent transdermal technology incorporates aversive agents into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential. The AVERSA™ abuse-deterrent technology has the potential to improve the safety profile of transdermal drugs susceptible to abuse, such as fentanyl, while making sure that these drugs remain accessible to those patients who really need them. The technology is covered by a broad intellectual property portfolio with patents granted in the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia.

 

About Nutriband, Inc.

 

We are primarily engaged in the development of a portfolio of transdermal pharmaceutical products. Our lead product under development is an abuse-deterrent fentanyl patch incorporating our AVERSA™ abuse-deterrent technology. AVERSA™ technology can be incorporated into any transdermal patch to prevent the abuse, misuse, diversion, and accidental exposure of drugs with abuse potential. The Company’s website is www.nutriband.com. Any material contained in or derived from the Company’s websites or any other website is not part of this press release.

 

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About Brand Institute, Inc., and wholly owned regulatory subsidiary, Drug Safety Institute Brand Institute is the global leader in pharmaceutical and healthcare-related name development, with a portfolio of over 5,000 marketed healthcare brand names and 1,800 USAN/INN nonproprietary names for nearly 1,600 clients. The company partners on over 75% of pharmaceutical brand and nonproprietary name approvals globally every year with healthcare manufacturers. Drug Safety Institute is composed of former naming regulatory officials from global government health agencies, including Food and Drug Administration (FDA), European Medicines Agency (EMA), Health Canada (HC), American Medical Association (AMA), and the World Health Organization (WHO). These regulatory experts co-authored the name review guidelines while with their former respective agencies, with many responsible for ultimately approving (or rejecting) brand name applications to ensure safety and prevent medication errors. To learn more about Brand Institute’s capabilities and experience, please visit www.brandinstitute.com and contact your local Brand Institute representative.

 

Forward-Looking Statements

 

Certain statements contained in this press release, including, without limitation, statements containing the words ‘‘believes,” “anticipates,” “expects” and words of similar import, constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve both known and unknown risks and uncertainties. The Company’s actual results may differ materially from those anticipated in its forward-looking statements as a result of a number of factors, including those including the Company’s ability to develop its proposed abuse-deterrent fentanyl transdermal system and other proposed products, its ability to obtain patent protection for its abuse technology, its ability to obtain the necessary financing to develop products and conduct the necessary clinical testing, its ability to obtain Federal Food and Drug Administration approval to market any product it may develop in the United States and to obtain any other regulatory approval necessary to market any product in other countries, including countries in Europe, its ability to market any product it may develop, its ability to create, sustain, manage or forecast its growth; its ability to attract and retain key personnel; changes in the Company’s business strategy or development plans;

 

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FAQ

What did Nutriband (NTRB) announce about its lead fentanyl patch?

Nutriband announced it has selected a commercial worldwide brand name candidate for its lead abuse-deterrent fentanyl transdermal patch. The proposed name and labeling will be submitted to the FDA and other regulators for review and approval as product development continues.

How large could the market be for Nutriband (NTRB)’s abuse-deterrent fentanyl patch?

Nutriband reports that its abuse-deterrent fentanyl transdermal system has potential peak annual U.S. sales of $80 million to $200 million. This estimate comes from a market analysis and reflects expected demand for safer pain-management options in the fentanyl patch segment.

What technology underpins Nutriband (NTRB)’s abuse-deterrent fentanyl patch?

The patch uses Nutriband’s AVERSA™ abuse-deterrent transdermal technology, which incorporates aversive agents into patches to deter abuse, diversion, misuse, and accidental exposure. AVERSA™ aims to improve safety for drugs with abuse potential, such as fentanyl, while keeping them available for appropriate patients.

How extensive is the patent protection for Nutriband (NTRB)’s AVERSA™ technology?

Nutriband states that its AVERSA™ abuse-deterrent transdermal technology is protected by a broad international intellectual property portfolio. Patents have been issued in 46 countries, including the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia.

Who is helping Nutriband (NTRB) develop the brand for its fentanyl patch?

Nutriband partnered with Brand Institute, Inc., described as a global leader in pharmaceutical and healthcare-related name development. Brand Institute is developing the worldwide commercial brand name and visual identity, while its subsidiary Drug Safety Institute provides regulatory naming expertise.

Is Nutriband (NTRB)’s abuse-deterrent fentanyl patch approved by the FDA?

The filing describes the fentanyl patch as a product under development, with the proposed brand name and labeling to be submitted to the FDA and other regulators. It does not state that the product has received marketing approval in the United States or elsewhere.

Filing Exhibits & Attachments

5 documents