Nutriband and Kindeva Complete Commercial Manufacturing Process Scale-up for Aversa™ Fentanyl Abuse Deterrent Fentanyl Patch

Rhea-AI Summary

Nutriband (NASDAQ:NTRB) has achieved a significant milestone by completing the commercial manufacturing process scale-up for Aversa™ Fentanyl, its pioneering abuse-deterrent fentanyl patch, in partnership with Kindeva. The product combines Nutriband's Aversa™ abuse-deterrent technology with Kindeva's FDA-approved fentanyl patch, manufactured at Kindeva's U.S.-based transdermal facility. The next phase involves manufacturing clinical supplies and filing an IND application with the FDA for human abuse liability studies. Aversa™ Fentanyl aims to be the first abuse-deterrent pain patch globally, incorporating aversive agents to prevent abuse, diversion, misuse, and accidental exposure of drugs. The technology is protected by patents in 46 countries and has potential peak annual US sales of $80-200 million, with plans for global market expansion.

Positive

• Successful completion of commercial manufacturing process scale-up, demonstrating technology viability
• Potential to be the first abuse-deterrent pain patch on the market
• Projected peak annual US sales of $80-200 million
• Strong intellectual property protection with patents in 46 countries
• Partnership with established CDMO Kindeva for manufacturing

Negative

• Still requires FDA IND application and human abuse liability studies before approval
• Market limited initially to US, pending global expansion
• Dependent on successful clinical trial outcomes

Nutriband and Kindeva have completed commercial manufacturing process scale-up for its lead product Aversa™ Fentanyl, an abuse-deterrent fentanyl patch

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., June 18, 2025 (GLOBE NEWSWIRE) -- Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW), a company engaged in the development of prescription transdermal pharmaceutical products, today announced that it has completed commercial manufacturing process scale-up for its lead product, Aversa™ Fentanyl, with Kindeva, a leading global contract development and manufacturing organization (CDMO) focused on drug-device combination products.

Nutriband is partnering with Kindeva to develop Aversa™ Fentanyl which combines Nutriband’s Aversa™ abuse-deterrent technology with Kindeva’s FDA-approved fentanyl patch. Aversa Fentanyl is manufactured at Kindeva’s state-of-the-art transdermal manufacturing facility located in the United States. The next step is to manufacture clinical supplies and file an Investigational New Drug (IND) application with the FDA to initiate a human abuse liability clinical study.

“We are excited to achieve this commercial development milestone with our partner, Kindeva. Completing the commercial manufacturing scale-up is an important step towards development of a commercially viable product and eventual NDA filing. This achievement demonstrates the compatibility of the Aversa™ abuse deterrent platform technology with established transdermal patch manufacturing processes. Aversa Fentanyl has the potential to be the first abuse deterrent pain patch on the market,” said Gareth Sheridan, CEO, Nutriband.

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 a global solution strategically targeting 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 potential market size for Nutriband's (NTRB) Aversa Fentanyl patch?

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

What is the current development status of NTRB's Aversa Fentanyl patch?

Nutriband has completed commercial manufacturing process scale-up and is preparing to manufacture clinical supplies and file an IND application with the FDA for human abuse liability studies.

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

The technology incorporates aversive agents into transdermal patches to prevent abuse, diversion, misuse, and accidental exposure of drugs with abuse potential, including opioids and stimulants.

What patents protect Nutriband's Aversa technology?

The technology is protected by patents issued in 46 countries including the US, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia.

Who is manufacturing Nutriband's Aversa Fentanyl patch?

Kindeva, a leading global CDMO focused on drug-device combination products, is manufacturing the patch at their US-based transdermal manufacturing facility.