Nutriband announced that the FDA has granted a Type C Meeting for its lead product, AVERSA™ FENTANYL (abuse deterrent fentanyl transdermal system). The purpose of the meeting is 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) and subsequent commercialization.
The meeting is scheduled as a virtual face-to-face meeting to be held on September 18, 2025 with the Division of Anesthesiology, Addiction Medicine, and Pain Medicine (DAAP) in the Office of Neuroscience (ON), Center for Drug Evaluation and Research (CDER).
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 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.
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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