Nutriband Provides Clinical and Regulatory Path Overview for Lead Product - AVERSA(R) Fentanyl Transdermal Patch

NDA will be primarily based on a single Phase 1 human abuse potential clinical study with no Phase 2 or 3 clinical trials needed prior to submission.

AVERSA Fentanyl incorporates Nutriband's Aversa abuse-deterrent technology with an FDA-approved fentanyl patch and is being developed via a limited 505(b)(2) New Drug Application (NDA) pathway.

ORLANDO, FL / ACCESSWIRE / March 27, 2024 / Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW), a company engaged in the development of prescription transdermal pharmaceutical products, today provided an overview of the clinical development and regulatory pathway for its lead product, AVERSA Fentanyl, an abuse-deterrent fentanyl transdermal patch.

Nutriband has partnered with Kindeva Drug Delivery, a leading global contract development and manufacturing organization, to incorporate Nutriband's AVERSA abuse-deterrent transdermal technology into Kindeva's FDA-approved transdermal fentanyl patch system. As Nutriband's abuse-deterrent technology is incorporated into the fentanyl patch but is physically separate and does not come in contact with the drug layer, the clinical trials typically needed to demonstrate safety and efficacy for a new drug formulation are not required.

Nutriband plans to utilize the 505(b)(2) New Drug Application (NDA) regulatory pathway which limits the development required for products that contain drugs that have already been approved, and allows applicants to reference data already on file at the FDA. As a result, the NDA application will be primarily based on a single Phase 1 human abuse potential clinical study with no Phase 2 or 3 clinical trials needed. A clinical abuse potential study is typically performed in recreational drug abusers and is designed to demonstrate that the abuse-deterrent product is less preferable to recreational drug abusers than conventional fentanyl patches which contain no abuse-deterrent technology.

Following a successful Phase 1 clinical abuse potential study, Nutriband intends to file a 505(b)(2) NDA to the FDA for marketing approval of AVERSA Fentanyl, which has the potential to be the first and only abuse deterrent patch approved anywhere in the world. The AVERSA Fentanyl NDA has the potential to receive an expedited review by FDA as has been granted for certain abuse-deterrent oral opioid products, which shortens the regulatory review period to six months from the conventional 10-month FDA review cycle for NDAs.