Nutriband Signs Commercial Development And Clinical Supply Agreement With Kindeva Drug Delivery For Aversa Fentanyl, An Abuse Deterrent Fentanyl Patch
Nutriband Inc. a company engaged in the development of transdermal pharmaceutical products, today announced it has signed a commercial development and clinical supply agreement for their lead product, Aversa Fentanyl, with their partner, Kindeva Drug Delivery, a leading global contract development and manufacturing organization (CDMO) focused on drug-device combination products. Under this agreement, Kindeva will perform commercial manufacturing process development and manufacture clinical supplies for the human abuse liability clinical study required by the FDA in support of a New Drug Application (NDA). This new agreement replaces the previous feasibility agreement between the two companies which was focused on adapting Kindeva’s commercial transdermal manufacturing process to incorporate AVERSA abuse deterrent transdermal technology.
AVERSA Fentanyl combines Nutriband’s proprietary AVERSA abuse-deterrent transdermal technology with Kindeva’s FDA-approved transdermal fentanyl patch system with the potential to become the world’s first opioid patch with abuse deterrent properties. AVERSA Fentanyl is estimated to have the potential to reach peak annual US sales of $80M – $200M.1
“Execution of this commercial development agreement with our partner, Kindeva, will enable us to rapidly commercialize AVERSA Fentanyl and capitalize on its significant market potential. 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,” said Gareth Sheridan, CEO, Nutriband.
“Transdermal drug-delivery technologies continue to create positive health outcomes for patients globally,” said Kindeva Global Chief Commercial Officer David Stevens. “Kindeva brings more than a half a century of expertise in transdermal capabilities and innovation, and we appreciate Nutriband’s expertise and partnership in this next step in development to continue to bring new solutions to patients.”
About AVERSA Abuse Deterrent Transdermal Technology
Nutriband’s AVERSA abuse-deterrent transdermal 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. 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 technology is covered by a broad intellectual property portfolio with patents granted in the United States, Europe, Japan, Korea, Russia, Canada, Mexico, and Australia.
1 Health Advances Aversa Fentanyl market analysis report 2022
Source: Kindeva Drug Delivery