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

What is the AVERSA(TM) Fentanyl patch?

The AVERSA(TM) Fentanyl patch is an abuse-deterrent transdermal patch developed by Nutriband Inc. in partnership with Kindeva, designed to prevent abuse, diversion, misuse, and accidental exposure of fentanyl while maintaining therapeutic access for patients.

Why is the FDA Type C Meeting significant for Nutriband Inc.?

The FDA Type C Meeting, scheduled for September 18, 2025, is significant as it will review the Chemistry, Manufacturing, and Controls plans for AVERSA(TM) Fentanyl, marking a critical step towards regulatory approval and commercialization.

How does the AVERSA(TM) technology work?

AVERSA(TM) technology is integrated into transdermal patches to prevent the abuse and misuse of drugs with abuse potential, though the specific mechanisms are not detailed in the provided content.

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.

Who is involved in the development of the AVERSA(TM) Fentanyl patch?

Nutriband Inc. is developing the AVERSA(TM) Fentanyl patch in partnership with Kindeva, leveraging Nutriband’s abuse-deterrent technology and Kindeva’s FDA-approved fentanyl patch.

When is the FDA Type C Meeting scheduled?

The FDA Type C Meeting to review the AVERSA(TM) Fentanyl patch is scheduled for September 18, 2025.

Where can I find more information about Nutriband Inc. and the AVERSA(TM) Fentanyl patch?

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 benefits of the AVERSA(TM) Fentanyl patch?

The AVERSA(TM) Fentanyl patch aims to prevent abuse, diversion, misuse, and accidental exposure to fentanyl, addressing a critical need in opioid therapy while ensuring patients have access to necessary treatment.

Is the AVERSA(TM) technology patented?

Yes, the AVERSA(TM) technology is protected by patents in 46 countries, as mentioned in the content.

How does the AVERSA(TM) Fentanyl patch compare to existing opioid patches?

The AVERSA(TM) Fentanyl patch is positioned to be the world’s first abuse-deterrent opioid patch, differentiating it from existing options by incorporating technology specifically designed to prevent abuse and misuse.