FDA Grants Nutriband Meeting Request for Aversa™ Fentanyl Abuse Deterrent Fentanyl Patch

Rhea-AI Summary

Nutriband (NASDAQ:NTRB) has secured a Type C Meeting with the FDA for its AVERSA™ FENTANYL, a pioneering abuse-deterrent fentanyl transdermal system. The virtual meeting, scheduled for September 18, 2025, will focus on Chemistry, Manufacturing, and Controls (CMC) plans from IND submission through 505(b)(2) NDA approval.

The company is collaborating with Kindeva to combine Nutriband's AVERSA™ abuse-deterrent technology with Kindeva's FDA-approved fentanyl patch. The product aims to be the world's first abuse-deterrent opioid patch, with projected peak annual US sales of $80-200 million. The technology is protected by patents in 46 countries, including major markets worldwide.

Positive

• Potential to be first-to-market with abuse-deterrent opioid patch technology
• Projected peak annual US sales of $80-200 million
• Strong intellectual property protection with patents in 46 countries
• Partnership with Kindeva leveraging their FDA-approved fentanyl patch
• Global market expansion potential beyond US

Negative

• Product still requires full regulatory approval pathway including IND and NDA submissions
• Significant timeline to commercialization with multiple regulatory steps ahead
• Market success dependent on FDA approval and adoption in competitive pain management space

FDA grants meeting for AVERSA™ FENTANYL (abuse deterrent transdermal system) to provide feedback on the Chemistry, Manufacturing, and Controls plans for the product through commercialization.

Nutriband is partnering with Kindeva to develop AVERSA™ FENTANYL which combines Nutriband’s AVERSA™ abuse-deterrent technology with Kindeva’s FDA-approved fentanyl patch.

ORLANDO, Fla., Aug. 08, 2025 (GLOBE NEWSWIRE) -- Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW), a company engaged in the development of prescription transdermal pharmaceutical products, today announced that the United States Food and Drug Administration (US FDA) has granted a Type C Meeting for its lead product, AVERSA™ FENTANYL (abuse deterrent fentanyl transdermal system). The purpose of the meeting is to specifically provide feedback on the Chemistry, Manufacturing, and Controls (CMC) plans for the product from submission of an Investigational New Drug Application (IND) through approval of a 505(b)(2) New Drug Application (NDA) and subsequent commercialization.

The meeting is scheduled as a virtual face-to-face meeting to be held on September 18, 2025 with the Division of Anesthesiology, Addiction Medicine, and Pain Medicine (DAAP) in the Office of Neuroscience (ON), Center for Drug Evaluation and Research (CDER).

Nutriband is partnering with Kindeva to develop AVERSA™ FENTANYL which combines Nutriband’s AVERSA™ abuse-deterrent technology with Kindeva’s FDA-approved fentanyl patch.

Nutriband’s AVERSA™ abuse-deterrent technology can be 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 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.

AVERSA FENTANYL has the potential to be the world’s first abuse-deterrent opioid patch designed to deter the abuse and misuse and reduce the risk of accidental exposure of transdermal fentanyl patches. AVERSA FENTANYL 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 our goal is to make AVERSA FENTANYL available in all major medical markets in the world.

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.

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¹ 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.

About Kindeva

At Kindeva, we manufacture more tomorrows for patients worldwide. With best-in-class facilities and comprehensive CDMO services, we offer more than manufacturing—we deliver strategic value. Our global network of 10 manufacturing and R&D sites offer exceptional integrated knowledge and capabilities, including Annex 1-compliant state-of-the-art aseptic fill finish capacity and next-generation sustainable inhalation propellant technology. By combining expertise in injectable, pulmonary, nasal and dermal drug delivery, we help meet the demands of today and deliver the possibilities of tomorrow. Find out more at https://www.kindevadd.com.

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; competition; business disruptions; adverse publicity and international, national and local general economic and market conditions and risks generally associated with an undercapitalized developing company, as well as the risks contained under "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in the Company's Form S-1, Forms 10-K’s and Forms 10-Q’s, and the Company's other filings with the Securities and Exchange Commission. Except as required by applicable law, we undertake no obligation to revise or update any forward-looking statements to reflect any event or circumstance that may arise after the date hereof.

Contact Information:

Nutriband Inc.
Phone: 407-377-6695
Email: info@nutriband.com

SOURCE: Nutriband Inc.

FAQ

What is the significance of FDA granting Nutriband (NTRB) a Type C Meeting for AVERSA Fentanyl?

The Type C Meeting, scheduled for September 18, 2025, allows Nutriband to receive FDA feedback on Chemistry, Manufacturing, and Controls plans for AVERSA Fentanyl, which is crucial for advancing through IND submission to NDA approval.

What is the market potential for Nutriband's AVERSA Fentanyl patch?

According to market analysis, AVERSA Fentanyl has potential peak annual US sales of $80-200 million, with additional growth potential in major global medical markets.

How does Nutriband's AVERSA abuse-deterrent technology work?

AVERSA technology incorporates aversive agents into transdermal patches to prevent abuse, diversion, misuse, and accidental exposure of drugs with abuse potential, while maintaining accessibility for patients who need them.

What is the partnership between Nutriband and Kindeva for AVERSA Fentanyl?

Nutriband is partnering with Kindeva to combine Nutriband's AVERSA abuse-deterrent technology with Kindeva's FDA-approved fentanyl patch to develop the world's first abuse-deterrent opioid patch.

How strong is Nutriband's intellectual property protection for AVERSA technology?

The AVERSA abuse deterrent technology is protected by a broad international intellectual property portfolio with patents issued in 46 countries, including the US, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia.