Full Press Release Details
ANNOUNCES SUCCESSFUL MEETING COMPLETED WITH UNITED STATES FDA FOR ITS ABUSE DETERRENT FENTANYL PATCH
met with US FDA to obtain feedback on the Chemistry, Manufacturing, and Controls plans for AVERSA FENTANYL (abuse deterrent transdermal
system) through commercialization.
received final meeting minutes from FDA and is incorporating the feedback into the development program as it moves forward to an IND
filing in support of a Human Abuse Potential (HAP) clinical study for the product.
FL / ACCESSWIRE / October 28, 2025 / Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW), a company engaged in the development of prescription
transdermal pharmaceutical products, today announced that it has received final meeting minutes from its recent virtual face-to-face
meeting held on September 18, 2025 with the United States Food and Drug Administration (US FDA) for its lead product, AVERSA FENTANYL
(abuse deterrent fentanyl transdermal system). The meeting was held as a videoconference with the Division of Anesthesiology, Addiction
Medicine, and Pain Medicine (DAAP) in the Office of Neuroscience (ON), Center for Drug Evaluation and Research (CDER). The proposed indication
is management of pain in opioid-tolerant patients, severe enough to require daily, around-the-clock, long-term opioid treatment and for
which alternate treatment options are inadequate.
purpose of the meeting was 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).
main outcomes of the meeting were:
addition, the Division acknowledged that fentanyl patch abuse, misuse and accidental exposure is an important issue to address and offered
their support and guidance during the development program through additional meetings as needed. In the past, the FDA has put out several
warnings1,2 on the risks of fentanyl patch accidental exposure, particularly in children, but to date there have not been
any abuse deterrent fentanyl patches approved in the U.S, or in any other country to our knowledge. Nutriband's abuse deterrent
fentanyl patch has the potential to be the first abuse deterrent patch approved worldwide.
are thankful for the opportunity to discuss the CMC aspects of our abuse deterrent fentanyl patch with the Agency. We are excited to
incorporate the advice and constructive feedback that we received from the FDA into our development program as we move towards an IND
filing in support of a Human Abuse Potential clinical study," said Alan Smith, Ph.D., Chief Operating Officer of Nutriband, Inc.
and President of 4P Therapeutics subsidiary of 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 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.
FENTANYL has the potential to reach peak annual US sales of $80 million to $200 million.3 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.
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.
AVERSA Abuse-Deterrent Transdermal Technology
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.
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.
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.
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.
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.
Email: info@nutriband.com