Nutriband Differentiates Prescription Fentanyl from Illicit Fentanyl in Response to United States Executive Order Designating Fentanyl as a Weapon of Mass Destruction
Rhea-AI Summary
Nutriband (NASDAQ:NTRB) announced development of AVERSA™ FENTANYL, an abuse‑deterrent transdermal fentanyl system combining Nutriband’s AVERSA™ technology with Kindeva’s FDA‑approved fentanyl patch.
The company positioned this program in response to the U.S. Executive Order designating illicit fentanyl and core precursors as weapons of mass destruction (Dec 15, 2025), while stressing that FDA‑approved prescription fentanyl remains medically necessary. Nutriband cites ongoing abuse/accidental exposure risks and projects peak annual U.S. sales of $80M–$200M for AVERSA™ FENTANYL. The AVERSA™ IP portfolio includes patents issued in 46 countries.
Positive
- Partnership with Kindeva to develop AVERSA™ FENTANYL
- IP portfolio with patents issued in 46 countries
- Projected peak annual U.S. sales of $80M–$200M
Negative
- AVERSA™ FENTANYL not FDA approved; requires regulatory clearance
- Initial commercialization focus limited to the U.S. market
- Ongoing transdermal fentanyl abuse may invite heightened regulatory scrutiny
Key Figures
Market Reality Check
Peers on Argus
Before this release, NTRB was down 2%, while several biotech peers like CVM, OKYO, STRO and QNCX were also negative (e.g., STRO -8.24%, OKYO -5.18%), indicating broader sector softness even though momentum scanners did not flag a coordinated move.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Nov 24 | Conference appearance | Neutral | -2.1% | Announcement of upcoming Noble Capital emerging growth conference presentation. |
| Oct 28 | Regulatory meeting | Positive | +10.4% | FDA meeting confirming 505(b)(2) NDA path and guidance for AVERSA FENTANYL. |
| Oct 27 | Management change | Positive | -1.7% | Co‑founder Gareth Sheridan returning as CEO to lead toward 2026 NDA filing. |
| Oct 10 | Branding agreement | Positive | -5.1% | Agreement with Brand Institute to develop global brand name and identity. |
| Oct 08 | IP filing | Positive | +8.4% | Provisional patent filing to strengthen AVERSA transdermal abuse‑deterrent technology. |
Recent AVERSA FENTANYL milestones often saw strong positive reactions, while corporate or branding updates sometimes coincided with declines, indicating mixed alignment between news tone and short-term price moves.
Over the last few months, Nutriband has focused on advancing its AVERSA™ FENTANYL program and related IP. In October–November 2025, it completed a key FDA meeting confirming a 505(b)(2)-type path, filed a provisional patent to enhance its abuse‑deterrent technology, and engaged Brand Institute for global branding. Management changes and conference participation rounded out corporate updates. Today’s statement reinforces the medical role of prescription fentanyl and the potential of AVERSA™ FENTANYL, consistent with this strategic focus.
Market Pulse Summary
This announcement underscores the distinction between illicit fentanyl, designated a weapon of mass destruction, and FDA‑approved transdermal fentanyl patches for severe chronic pain. Nutriband highlights AVERSA™ FENTANYL, an abuse‑deterrent patch with cited peak U.S. sales potential of $80M–$200M and patent coverage in 46 countries. Set against recent 10‑Q data showing a nine‑month net loss of $7.26M and cash of $5.31M, key factors to watch include regulatory progress, clinical data, and funding strategy for late‑stage development.
Key Terms
transdermal medical
abuse deterrent medical
weapons of mass destruction regulatory
precursor chemicals regulatory
opioid-tolerant medical
AI-generated analysis. Not financial advice.
Prescription pharmaceutical transdermal fentanyl is a valuable treatment for management of pain in opioid-tolerant patients, severe enough to require daily, around-the-clock, long-term opioid treatment for which alternate treatment options are inadequate.
Illicit fentanyl and its core precursor chemicals have been designated as weapons of mass destruction to enable the US government to combat the manufacture and distribution by cartels and foreign networks that have flooded the US with illegal fentanyl.
Nutriband is developing Aversa™ Fentanyl, an abuse deterrent fentanyl transdermal system, which combines Nutriband’s proprietary Aversa™ abuse-deterrent technology with Kindeva’s FDA-approved fentanyl patch.
ORLANDO, Fla., Dec. 18, 2025 (GLOBE NEWSWIRE) -- Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW), a company engaged in the development of prescription transdermal pharmaceutical products, provides the following response to the Trump Administration’s Executive Order designating illicit fentanyl and its core precursor chemicals as weapons of mass destruction.1
“The designation of illicit fentanyl as a weapon of mass destruction reflects the extreme danger posed by illegally manufactured and trafficked fentanyl and fentanyl-laced products. However, this designation must not be conflated with FDA-approved prescription fentanyl therapies, such as transdermal fentanyl patches, which are produced under rigorous regulatory oversight and prescribed to patients suffering from severe chronic pain. These medically necessary products serve a critical role in patient care and access must be maintained while aggressively combating illicit fentanyl entering the country through illegal, unregulated channels. Chronic pain patients cannot be forced to suffer due to a lack of access to appropriate medications used in the management of their condition, including all FDA approved prescription fentanyl products.”
FDA-approved transdermal fentanyl patches are indicated for the 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. However, transdermal fentanyl patch abuse and accidental pediatric exposures to patches continue to be a serious problem resulting in major medical outcomes and death, suggesting an unmet need for safer abuse deterrent versions of these patches. Transdermal fentanyl abuse and overdose, continues to be an epidemic which can lead to the abuse of prescription transdermal fentanyl and other opioid containing transdermal 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. Nutriband’s AVERSA™ abuse-deterrent technology can be utilized to incorporate aversive agents into transdermal patches to deter abuse, including oral abuse, of any drug with a risk of abuse, misuse, and accidental exposure such as opioids and stimulants. 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
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 https://www.whitehouse.gov/presidential-actions/2025/12/designating-fentanyl-as-a-weapon-of-mass-destruction/ White House Presidential Executive Order December 15, 2025
2 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.
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 did Nutriband (NTRB) announce on December 18, 2025 regarding AVERSA™ FENTANYL?
How does the U.S. Executive Order dated December 15, 2025 relate to Nutriband’s announcement?
What peak U.S. sales does Nutriband estimate for AVERSA™ FENTANYL (NTRB)?
Does AVERSA™ FENTANYL have FDA approval for sale in the U.S.?
What intellectual property protection does Nutriband claim for AVERSA™ technology?
