Nutriband Inc., a company that develops transdermal pharmaceutical products has signed a commercial development and clinical supply agreement with its partner, Kindeva Drug Delivery.
The agreement is for Nutriband’s lead product Aversa Fentanyl. Under the agreement, CDMO 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.
Rapidly commercialize Aversa Fentanyl
“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.
Aversa Fentanyl combines Nutriband’s 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.
The lead product is estimated to have the potential to reach peak annual US sales of $80-200 million.
Transdermal drug-delivery tech
“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 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.”
Nutriband’s abuse-deterrent transdermal 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.
Fentanyl is a potent synthetic piperidine opioid primarily used as an analgesic. It’s between 20 and 40 times more potent than heroin and 100 times more potent than morphine. It is primarily used in a clinical setting for pain management in cancer patients or those recovering from painful surgeries. It can also be used as a sedative.
Curbing opioid misuse
Between 1999 and 2020, it was reported by the Congressional Research Service that 565,000 Americans died of opioid-involved overdoses. In turn, federal, state, and local governments responded with various legal and policy efforts to curb opioid misuse and drug-related overdose deaths.
Nutriband's technology is covered by a broad intellectual property portfolio with patents granted in the United States, Europe, Japan, Korea, Russia, Canada, Mexico, and Australia.
The company is primarily engaged in the development of a portfolio of transdermal pharmaceutical products with its lead product under development being an abuse-deterrent fentanyl patch incorporating abuse-deterrent technology.
The technology can be incorporated into any transdermal patch to prevent the abuse, misuse, diversion, and accidental exposure of drugs with abuse potential.
Kindeva develops and manufactures products across a broad range of complex drug-delivery formats, including pulmonary and nasal, injectable, and transdermal. Its service offerings span early-stage feasibility through commercial-scale drug product fill-finish, container closure system manufacturing, and drug-device product assembly.