FAQ on Nutriband Inc.'s FDA Type C Meeting for AVERSA(TM) Fentanyl Abuse-Deterrent Patch

Summary
Nutriband Inc. has secured a Type C Meeting with the FDA to review its AVERSA(TM) Fentanyl patch, an abuse-deterrent opioid patch developed with Kindeva, targeting significant U.S. sales potential and global market expansion.
What is the AVERSA(TM) Fentanyl patch?
The AVERSA(TM) Fentanyl patch is an abuse-deterrent opioid patch developed by Nutriband Inc. in partnership with Kindeva, designed to prevent abuse, diversion, misuse, and accidental exposure while ensuring access for patients in need.
Why is the FDA Type C Meeting significant for Nutriband Inc.?
The FDA Type C Meeting is significant as it allows Nutriband Inc. to review Chemistry, Manufacturing, and Controls plans for its AVERSA(TM) Fentanyl patch, a critical step towards regulatory approval and commercialization.
When is the FDA Type C Meeting scheduled?
The FDA Type C Meeting is scheduled for September 18, 2025.
What is the potential market size for the AVERSA(TM) Fentanyl patch?
The AVERSA(TM) Fentanyl patch targets peak annual U.S. sales potential of $80 million to $200 million, with plans for future global market expansion.
How does the AVERSA(TM) technology work?
The AVERSA(TM) technology can be incorporated into any transdermal patch to prevent the abuse, misuse, diversion, and accidental exposure of drugs with abuse potential.
Who is Nutriband Inc.?
Nutriband Inc. is a developer of prescription transdermal pharmaceutical products, focusing on abuse-deterrent technologies like the AVERSA(TM) Fentanyl patch.
Where can I find more information about Nutriband Inc. and its products?
More information can be found on Nutriband Inc.’s website at www.nutriband.com or in the company’s newsroom at https://ibn.fm/NTRB.
What are the implications of the AVERSA(TM) Fentanyl patch for the opioid crisis?
The AVERSA(TM) Fentanyl patch represents a significant advancement in addressing the opioid crisis by providing an abuse-deterrent option that reduces the risk of misuse while maintaining therapeutic access for patients.
Is the AVERSA(TM) technology patented?
Yes, the AVERSA(TM) technology is protected by patents in 46 countries.

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