Wed. 27 Mar 2024, 5:57am ET
Benzinga
News, Health Care, General
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.