Core Viewpoint - Nutriband has successfully completed the commercial manufacturing process scale-up for its lead product, Aversa™ Fentanyl, in partnership with Kindeva, marking a significant milestone towards developing a commercially viable abuse-deterrent fentanyl patch [1][3]. Group 1: Product Development - Aversa™ Fentanyl combines Nutriband's abuse-deterrent technology with Kindeva's FDA-approved fentanyl patch, and is manufactured at Kindeva's advanced transdermal facility in the United States [2]. - The next steps include manufacturing clinical supplies and filing an Investigational New Drug (IND) application with the FDA to initiate a human abuse liability clinical study [2]. Group 2: Market Potential - Aversa Fentanyl has the potential to be the first abuse-deterrent opioid patch on the market, aimed at deterring abuse and reducing accidental exposure risks, with projected peak annual US sales between $80 million to $200 million [5]. - The company plans to initially focus on the US market while also targeting global markets due to the widespread unmet medical need for effective pain management [5]. Group 3: Technology and Intellectual Property - Nutriband's AVERSA™ abuse-deterrent technology incorporates aversive agents into transdermal patches to prevent drug abuse, ensuring that these medications remain accessible to patients in need [4][7]. - The technology is protected by a broad international intellectual property portfolio, with patents issued in 46 countries, including major markets such as the United States, Europe, and China [6][7].
Nutriband and Kindeva Complete Commercial Manufacturing Process Scale-up for Aversa™ Fentanyl Abuse Deterrent Fentanyl Patch