Nutriband announced that it has completed commercial manufacturing process scale-up for its lead product, Aversa™ Fentanyl, with Kindeva, a global contract development and manufacturing organization (CDMO) focused on drug-device combination products.
Nutriband is partnering with Kindeva to develop Aversa™ Fentanyl which combines Nutriband’s Aversa™ abuse-deterrent technology with Kindeva’s FDA-approved fentanyl patch. Aversa Fentanyl is manufactured at Kindeva’s state-of-the-art transdermal manufacturing facility located in the United States. 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.
“We are excited to achieve this commercial development milestone with our partner, Kindeva. 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. Aversa Fentanyl has the potential to be the first abuse deterrent pain patch on the market,” said Gareth Sheridan, CEO, Nutriband.
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.
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. AVERSA Fentanyl has the potential to reach peak annual US sales of $80 million to $200 million.1 While initially concentrating on the US market, the unmet medical need for adequate pain management is a global problem, and our goal is to make AVERSA a global solution strategically targeting all major medical markets in the world.
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.