Nutriband and Kindeva have successfully scaled up manufacturing for Aversa™ Fentanyl, an abuse-deterrent fentanyl patch.
Quiver AI Summary
Nutriband Inc. has successfully completed the scale-up of the commercial manufacturing process for its lead product, Aversa™ Fentanyl, in partnership with Kindeva, a contract development and manufacturing organization. Aversa™ Fentanyl is an abuse-deterrent fentanyl patch that combines Nutriband's proprietary technology with Kindeva's FDA-approved fentanyl patch. The product will be manufactured in a state-of-the-art facility in the United States, with plans to produce clinical supplies and submit an Investigational New Drug application to the FDA for a clinical study on abuse liability. Nutriband’s Aversa™ technology aims to enhance the safety of transdermal drugs by incorporating aversive agents, reducing the risk of misuse, and ensuring access for patients in need. The company projects significant market potential for Aversa™ Fentanyl and aims to make it a global solution for pain management, supported by a robust international patent portfolio.
Potential Positives
- Nutriband has successfully completed the commercial manufacturing process scale-up for Aversa™ Fentanyl, a significant milestone in the development of an abuse-deterrent pain management solution.
- The partnership with Kindeva leverages their FDA-approved fentanyl patch and enhances the credibility and manufacturing capabilities for Aversa Fentanyl.
- Aversa Fentanyl has the potential to be the first abuse-deterrent opioid patch on the market, addressing a crucial need in pain management while tackling issues of drug abuse and misuse.
- The product is backed by a strong international intellectual property portfolio, with patents issued in 46 countries, providing competitive advantages and market protection.
Potential Negatives
- Completion of commercial manufacturing process scale-up does not guarantee FDA approval, with upcoming clinical studies posing significant risks and uncertainties that could hinder product development.
- The company faces substantial associated financial risks related to the need for funding to conduct required clinical testing and obtain regulatory approvals.
- High competition in the market for abuse-deterrent products may impact Nutriband's ability to capture projected sales despite optimistic forecasts.
FAQ
What is Aversa™ Fentanyl?
Aversa™ Fentanyl is an abuse-deterrent fentanyl patch developed by Nutriband in partnership with Kindeva.
What technology does Aversa™ Fentanyl use?
Aversa™ Fentanyl utilizes Nutriband's AVERSA™ abuse-deterrent technology to prevent misuse and accidental exposure.
Where is Aversa™ Fentanyl manufactured?
Aversa™ Fentanyl is manufactured at Kindeva's state-of-the-art transdermal manufacturing facility in the United States.
What are the future plans for Aversa™ Fentanyl?
The next steps include manufacturing clinical supplies and filing an IND application with the FDA.
What is the market potential for Aversa™ Fentanyl?
Aversa™ Fentanyl may achieve peak US sales ranging from $80 million to $200 million annually.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
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:
[email protected]
SOURCE: Nutriband Inc.
