Nutriband Inc., a developer of prescription transdermal pharmaceutical products, has completed the commercial manufacturing process scale-up for Aversa Fentanyl, in collaboration with Kindeva, a CDMO focused on drug-device combination products.

Aversa Fentanyl combines Nutriband’s Aversa abuse-deterrent technology with Kindeva’s FDA-approved fentanyl patch. Aversa Fentanyl is manufactured at Kindeva’s transdermal manufacturing facility in the U.S. 

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.

Nutriband’s Aversa abuse-deterrent technology can be used 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 next step is to manufacture clinical supplies and file an Investigational New Drug (IND) application with the FDA to initiate a human abuse liability clinical study.

“Completing the commercial manufacturing scale-up is an important step towards development of a commercially viable product and eventual NDA filing. This achievement demonstrates the compatibility of the Aversa™ abuse deterrent platform technology with established transdermal patch manufacturing processes,” said Gareth Sheridan, CEO of Nutriband.

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.