Nutriband has closed the $8.4 million private placement to fund the commercial development program for its lead product, AVERSA Fentanyl. 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. Nutriband is currently working with its partner Kindeva Drug Delivery, a leading global contract development and manufacturing organization, to develop the commercial scale manufacturing process for the final product which will incorporate Nutriband’s AVERSA abuse-deterrent transdermal technology into Kindeva’s FDA-approved transdermal fentanyl patch system. With this latest round of funding and based on progress made on the commercial transdermal manufacturing process scale-up to date, Nutriband is pushing towards the following development milestones: FDA Pre-IND Meeting; Pivotal Laboratory Manipulation and Extraction Study; FDA IND Filing; Pivotal Human Abuse Potential Clinical Study; New Drug Application Filing 505(b)(2) NDA; FDA Review and Approval. The Company is targeting Q1 of 2025 to file its NDA for marketing approval.
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