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Posted On: 06/20/2024 5:28:10 PM
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NetworkNewsBreaks – Nutriband Inc. (NASDAQ: NTRB) Shares Update on Its AVERSA(TM) Fentanyl Product Development Program
Nutriband (NASDAQ: NTRB), a pharmaceutical company with a special focus on transdermal technologies, today provided an update on its AVERSA(TM) Fentanyl product development program. This comes as the company plans to complete scale-up of the commercial manufacturing process and move towards the single Phase 1 human abuse potential study prior to a New Drug Application (“NDA”) filing. According to the update, Nutriband is currently working with its partner Kindeva Drug Delivery to develop the commercial scale manufacturing process for the final product, which will incorporate Nutriband’s AVERSA(TM) abuse-deterrent transdermal technology into Kindeva’s FDA-approved transdermal fentanyl patch system. The update noted that once final commercial product manufacturing is completed, Nutriband intends to file an Investigational New Drug (“IND”) with the FDA and perform the pivotal laboratory and clinical evaluations to demonstrate the abuse-deterrent properties of AVERSA Fentanyl, in compliance with FDA Guidance. The company plans to file the IND application with the FDA prior to conducting the single Phase 1 human abuse potential clinical study required for the NDA.
NOTE TO INVESTORS: The latest news and updates relating to NTRB are available in the company’s newsroom at https://nnw.fm/NTRB
Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or republished: http://NNW.fm/Disclaimer
Nutriband (NASDAQ: NTRB), a pharmaceutical company with a special focus on transdermal technologies, today provided an update on its AVERSA(TM) Fentanyl product development program. This comes as the company plans to complete scale-up of the commercial manufacturing process and move towards the single Phase 1 human abuse potential study prior to a New Drug Application (“NDA”) filing. According to the update, Nutriband is currently working with its partner Kindeva Drug Delivery to develop the commercial scale manufacturing process for the final product, which will incorporate Nutriband’s AVERSA(TM) abuse-deterrent transdermal technology into Kindeva’s FDA-approved transdermal fentanyl patch system. The update noted that once final commercial product manufacturing is completed, Nutriband intends to file an Investigational New Drug (“IND”) with the FDA and perform the pivotal laboratory and clinical evaluations to demonstrate the abuse-deterrent properties of AVERSA Fentanyl, in compliance with FDA Guidance. The company plans to file the IND application with the FDA prior to conducting the single Phase 1 human abuse potential clinical study required for the NDA.
NOTE TO INVESTORS: The latest news and updates relating to NTRB are available in the company’s newsroom at https://nnw.fm/NTRB
Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or republished: http://NNW.fm/Disclaimer
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