Milestone achieved for Aversa Fentanyl, a transdermal patch combining proven delivery with abuse-deterrent technology

Nutriband and its development partner Kindeva have completed commercial manufacturing process scale-up for Aversa Fentanyl, a transdermal fentanyl patch designed to deter abuse and misuse.

The product combines Nutriband’s proprietary Aversa technology with Kindeva’s FDA-approved fentanyl patch and is being manufactured at Kindeva’s advanced US-based transdermal facility. The scale-up milestone supports the next stage of development, including manufacturing clinical supplies and submitting an Investigational New Drug (IND) application to initiate a human abuse liability study.

Gareth Sheridan, CEO of Nutriband, said: “Completing the commercial manufacturing scale-up is an important step toward developing a commercially viable product and eventual NDA filing. This milestone demonstrates that the Aversa platform can be integrated into established transdermal manufacturing processes. Aversa Fentanyl could become the first abuse-deterrent pain patch available.”

Aversa technology incorporates aversive agents into transdermal systems to prevent misuse, diversion, and accidental exposure-challenges particularly relevant to opioids and stimulants. The goal is to enhance the safety of high-risk medications while ensuring they remain accessible to patients who need them.

Aversa Fentanyl has the potential to be the world’s first opioid patch specifically designed to reduce the risk of abuse and accidental exposure. The company estimates US peak annual sales could range from $80 million to $200 million. While initial focus is on the US market, Nutriband ultimately aims to position Aversa Fentanyl as a global solution for pain management in regions with high unmet need.