Nutriband introduced a profitable suggestions assembly with the US Meals and Drug Administration (FDA) relating to their abuse deterrent fentanyl patch. The corporate acquired last assembly notes relating to the Chemistry, Manufacturing, and Controls (CMC) plan for the Aversa abuse deterrent fentanyl transdermal system.1
The assembly outcomes reported had been affirmation of the New Drug Software (NDA) regulatory pathway for the patch, because it consists of an already accepted drug formulation. FDA additionally supplied suggestions on registration batch and manufacturing course of validation methods. FDA famous issues and recommendation for finalizing the product and stability testing. Suggestions on deliberate laboratory research on the abuse-deterrent function had been particularly supplied. The assembly was held with the Division of Anesthesiology, Habit Drugs, and Ache Drugs within the Workplace of Neuroscience, Heart for Drug Analysis and Analysis.
Deliberate research for the abuse-deterrent function are laboratory based mostly, in vitro manipulation and extraction research. To completely perceive the abuse-deterrent properties, the class 1 research will discover the diploma of effort required by a person to abuse, bypass, or defeat the deterrent parts. Within the assembly, the FDA additionally acknowledged the vital subject of fentanyl patch abuse and misuse or unintended publicity.2
“We’re grateful for the chance to debate the CMC features of our abuse deterrent fentanyl patch with the Company. We’re excited to include the recommendation and constructive suggestions that we acquired from the FDA into our improvement program as we transfer in direction of an IND submitting in help of a Human Abuse Potential medical research,” commented Alan Smith, PhD, the chief working officer of Nutriband, Inc, in a press launch.
The proposed indication for the patch is ache administration for sufferers with opiate tolerance who require every day and fixed long run opiate therapy, with no accessible options. The Aversa patch combines Nutriband’s new abuse-deterrent know-how with the FDA-approved fentanyl patch by Kindeva. The transdermal patch formulation makes use of the artificial opioid agonist fentanyl transported by way of the pores and skin and circulation, binding to receptors within the central nervous system to imitate endogenous opiates.3 Utilizing abuse-deterrent types for fentanyl patches goals to stop abuse, diversion, misuse, and unintended publicity of medicine with larger abuse potential. Deterrent know-how can embody incorporating aversive brokers right into a patch, whereas nonetheless protecting the medicine accessible to sufferers in want.
Nutriband will transfer ahead with an investigational new drug submitting in help of a Human Abuse Potential medical research for this patch therapy. If the Aversa abuse-deterrent fentanyl patch is accepted, it might be the primary of its sort.
References
1. Nutriband broadcasts profitable assembly accomplished with United States FDA for its abuse deterrent fentanyl patch. Information launch. October 28, 2025. Accessed October 28, 2025.
2. Unintended exposures to fentanyl patches proceed to be lethal to youngsters. FDA. Accessed October 28, 2025.
3. Fentanyl matrix transdermal patch. Nationwide Most cancers Institute. Accessed October 28, 2025.