FDA Grants Type C Meeting for Aversa Fentanyl Abuse Deterrent Patch

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The US Food and Drug Administration (FDA) has granted a Type C Meeting for Nutriband’s lead product, Aversa fentanyl, or the abuse deterrent fentanyl transdermal system. In the meeting, the FDA will specifically provide feedback on the chemistry, manufacturing, and controls plans for Aversa fentanyl from the submission of an Investigational New Drug Application through approval of a 505(b)(2) New Drug Application and subsequent commercialization.¹

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.

The meeting is scheduled to be held on September 18, 2025, with the division of anesthesiology, addiction medicine, and pain medicine in the Office of Neuroscience, Center for Drug Evaluation and Research. It will be a virtual face-to-face meeting.

Aversa fentanyl was developed by Nutriband in partnership with Kindeva, combining Nutriband’s Aversa abuse-deterrent technology with Kindeva’s FDA-approved fentanyl patch. The 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, such as opioids and stimulants. This technology has the potential to improve the safety profile of transdermal drugs susceptible to abuse, in this case fentanyl, while making sure that these drugs remain accessible to patients who require them.

Transdermal fentanyl is FDA-approved for patients with moderate to severe chronic noncancer and cancer-associated pain receiving at least 1 week or more of treatment with 60 mg/day morphine or other sufficient doses of opiate medication. The patient's chronic pain must demonstrate (1) tolerance to opioid medication, (2) be intractable, and (3) require constant analgesic effects.^2,3 Utilizing the transdermal route eliminates the first-pass metabolism of fentanyl via the liver, making it possible to use lower doses of the drug and thus reduce the incidence of adverse effects. Research has shown that, compared with sustained-release oral morphine, transdermal fentanyl has a 30% lower incidence of adverse effects such as constipation and sedation (P<0.05), and is as safe and effective in treating chronic cancer pain.⁴

Accidental exposure is a top concern with fentanyl patches, particularly in children. According to the FDA, accidental exposure to medication is a leading cause of poisoning in children, and many have died or become seriously ill after being exposed to a skin patch containing fentanyl.⁵ While proper storage and disposal lowers the risk of accidental exposure, this new Aversa fentanyl technology could greatly improve the safety of transdermal patches susceptible to abuse.

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.¹

It is worth nothing that while Aversa fentanyl shows great promise and could target a huge unmet need, this meeting could indicate potential concerns or delays regarding Aversa fentanyl’s chemistry, manufacturing, and controls plans, which could affect its timely commercialization.⁶

References

1. FDA grants Nutriband meeting request for Aversa™ fentanyl abuse deterrent fentanyl patch. News release. August 8, 2025. Accessed August 8, 2025. https://www.theglobeandmail.com/investing/markets/markets-news/GlobeNewswire/33997328/fda-grants-nutriband-meeting-request-for-aversa-fentanyl-abuse-deterrent-fentanyl-patch/

2. Skaer TL. Transdermal opioids for cancer pain. Health Qual Life Outcomes. 2006;4:24.

3. Gulur P, Williams L, Chaudhary S, et al. Opioid tolerance--a predictor of increased length of stay and higher readmission rates. Pain Physician. 2014;17(4):E503-7.

4. Taylor KP, Singh K, Goyal A. Fentanyl transdermal. In: StatPearls [Internet]. StatPearls Publishing; 2025 Jan.

5. Accidental exposures to fentanyl patches continue to be deadly to children. US Food and Drug Administration. Accessed August 8, 2025. https://www.fda.gov/consumers/consumer-updates/accidental-exposures-fentanyl-patches-continue-be-deadly-children

6. Nutriband Inc. announces FDA meeting for AVERSA™ FENTANYL to discuss CMC plans through commercialization. Quiver Quantitative. August 8, 2025. Accessed August 8, 2025. https://www.quiverquant.com/news/Nutriband+Inc.+Announces+FDA+Meeting+for+AVERSA™+FENTANYL+to+Discuss+CMC+Plans+Through+Commercialization