- Nutriband has completed commercial manufacturing process scale-up for Aversa™ Fentanyl in partnership with CDMO Kindeva.
- The companies are preparing to manufacture clinical supplies and file an IND application with the FDA.
Nutriband Inc., a developer of prescription transdermal pharmaceutical products, has completed commercial manufacturing process scale-up for its lead asset, Aversa™ Fentanyl, in collaboration with Kindeva, a global CDMO focused on drug-device combination products.
The product integrates Nutriband’s Aversa™ abuse-deterrent technology with Kindeva’s FDA-approved fentanyl patch and is being manufactured at Kindeva’s transdermal facility in the United States. The next step involves producing clinical trial materials and submitting an Investigational New Drug (IND) application to initiate human abuse liability studies.
“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,” said Gareth Sheridan, CEO of Nutriband. “This achievement demonstrates the compatibility of the Aversa™ abuse deterrent platform technology with established transdermal patch manufacturing processes.”
Aversa™ Fentanyl is positioned as a potential first-in-class abuse-deterrent opioid patch designed to deter misuse and reduce the risk of accidental exposure. The company estimates potential peak US annual sales between $80 million and $200 million.
The Aversa™ technology is protected by patents in 46 countries and is intended to enhance safety for transdermal drugs with high abuse potential, such as opioids and stimulants, while maintaining access for patients in need.
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