Nutriband and Kindeva Enhance Aversa Fentanyl Patch Production
Nutriband and Kindeva have successfully finished the scale-up of the commercial manufacturing process for their lead product, Aversa™ Fentanyl, an innovative abuse-deterrent fentanyl patch.
Nutriband is collaborating with Kindeva to develop Aversa™ Fentanyl, which integrates Nutriband's cutting-edge Aversa™ abuse-deterrent technology with Kindeva’s FDA-approved fentanyl patch. This partnership marks a significant step forward in the development of this essential medical product.
Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW), a company focused on creating prescription transdermal pharmaceutical products, announced that it has completed the commercial scale-up process with Kindeva, a renowned global contract development and manufacturing organization (CDMO). This organization specializes in developing drug-device combination products.
The Aversa™ Fentanyl patch is exclusively manufactured at Kindeva’s advanced transdermal manufacturing facility in the United States. Following this successful scale-up, the next phase involves manufacturing clinical supplies and submitting an Investigational New Drug (IND) application to the FDA. This will facilitate the initiation of a human abuse liability clinical study, paving the way for future developments.
“Achieving this milestone with Kindeva is thrilling for us. It not only highlights our commitment to bringing a commercially viable product to market but also reinforces the compatibility of our Aversa™ technology with established manufacturing processes,” stated Gareth Sheridan, CEO of Nutriband. “We believe Aversa Fentanyl holds the potential to be the first abuse-deterrent pain patch available commercially.”
Understanding AVERSA™ Technology
The AVERSA™ abuse-deterrent technology developed by Nutriband can effectively integrate aversive agents within transdermal patches. This innovation aims to prevent the misuse, diversion, and accidental exposure to drugs, particularly those with high potential for abuse such as opioids and stimulants.
AVERSA Fentanyl is poised to be the first of its kind—a transdermal patch designed not only to deliver medication but also to deter abuse and misuse while significantly minimizing the risk of unintended exposures. This feature is particularly crucial as the demand for effective pain management products grows.
Market Potential and Aspirations
The potential for AVERSA Fentanyl in the market is substantial, with projections estimating peak annual sales ranging from $80 million to $200 million. Initially, efforts will focus on the United States market due to the urgent need for effective pain management solutions. However, Nutriband recognizes that adequate pain management is a worldwide concern and aims to target all major medical markets globally.
The AVERSA™ abuse deterrent technology is safeguarded by a robust international intellectual property portfolio, holding patents in 46 countries. This includes major jurisdictions such as the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia, ensuring comprehensive protection for this critical innovation.
Overview of Nutriband Inc.
Nutriband Inc. is dedicated to developing a diverse portfolio of transdermal pharmaceutical products. Their flagship product under development is the Aversa™ fentanyl patch, which utilizes the AVERSA™ technology. This technology can be integrated into various transdermal patches, making it an invaluable asset in the fight against drug misuse and accidental exposure.
Contact them directly for any inquiries:
Nutriband Inc.
Phone: 407-377-6695
Email: info@nutriband.com
Frequently Asked Questions
What is Aversa Fentanyl?
Aversa Fentanyl is an innovative abuse-deterrent fentanyl patch developed by Nutriband in partnership with Kindeva.
What technology is used in Aversa Fentanyl?
The patch utilizes AVERSA™ abuse-deterrent technology to prevent misuse and accidental exposure to fentanyl.
What are the market projections for Aversa Fentanyl?
AVERSA Fentanyl has estimated peak US sales potential ranging from $80 million to $200 million.
Where is Aversa Fentanyl manufactured?
Aversa Fentanyl is manufactured at Kindeva’s advanced transdermal manufacturing facility in the United States.
What is the purpose of the clinical study for Aversa Fentanyl?
The clinical study aims to evaluate the human abuse liability of the Aversa Fentanyl patch, ensuring its safety and efficacy.
