Positive FDA Meeting for Abuse Deterrent Fentanyl Patch

Nutriband announced a successful feedback meeting with the US Food and Drug Administration (FDA) regarding their abuse deterrent fentanyl patch. The company received final meeting notes regarding the Chemistry, Manufacturing, and Controls (CMC) plan for the Aversa abuse deterrent fentanyl transdermal system.¹

The meeting outcomes reported were confirmation of the New Drug Application (NDA) regulatory pathway for the patch, as it includes an already approved drug formulation. FDA also provided feedback on registration batch and manufacturing process validation strategies. FDA noted considerations and advice for finalizing the product and stability testing. Feedback on planned laboratory studies on the abuse-deterrent feature were specifically provided. The meeting was held with the Division of Anesthesiology, Addiction Medicine, and Pain Medicine in the Office of Neuroscience, Center for Drug Evaluation and Research.

Planned studies for the abuse-deterrent feature are laboratory based, in vitro manipulation and extraction studies. To fully understand the abuse-deterrent properties, the category 1 studies will explore the degree of effort required by an individual to abuse, bypass, or defeat the deterrent elements. In the meeting, the FDA also acknowledged the important issue of fentanyl patch abuse and misuse or accidental exposure.²

"We 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," commented Alan Smith, PhD, the chief operating officer of Nutriband, Inc, in a press release.

The proposed indication for the patch is pain management for patients with opiate tolerance who require daily and constant long term opiate treatment, with no available alternatives. The Aversa patch combines Nutriband’s new abuse-deterrent technology with the FDA-approved fentanyl patch by Kindeva. The transdermal patch formulation uses the synthetic opioid agonist fentanyl transported through the skin and circulation, binding to receptors in the central nervous system to mimic endogenous opiates.³ Using abuse-deterrent forms for fentanyl patches aims to prevent abuse, diversion, misuse, and accidental exposure of drugs with higher abuse potential. Deterrent technology can include incorporating aversive agents into a patch, while still keeping the medication available to patients in need.

Nutriband will move forward with an investigational new drug filing in support of a Human Abuse Potential clinical study for this patch treatment. If the Aversa abuse-deterrent fentanyl patch is approved, it would be the first of its kind.

References

1. Nutriband announces successful meeting completed with United States FDA for its abuse deterrent fentanyl patch. News release. October 28, 2025. Accessed October 28, 2025. https://www.benzinga.com/pressreleases/25/10/g48456556/nutriband-announces-successful-meeting-completed-with-united-states-fda-for-its-abuse-deterrent-fe

2. Accidental exposures to fentanyl patches continue to be deadly to children. FDA. Accessed October 28, 2025. https://www.fda.gov/consumers/consumer-updates/accidental-exposures-fentanyl-patches-continue-be-deadly-children

3. Fentanyl matrix transdermal patch. National Cancer Institute. Accessed October 28, 2025. https://www.cancer.gov/publications/dictionaries/cancer-drug/def/fentanyl-matrix-transdermal-patch