Nutriband Provided An Overview Of The Clinical Development And Regulatory Pathway For Its Lead Product, Aversa Fentanyl, An Abuse-deterrent Fentanyl Transdermal Patch
Portfolio Pulse from Benzinga Newsdesk
Nutriband announced the clinical development and regulatory pathway for Aversa Fentanyl, an abuse-deterrent fentanyl transdermal patch. The NDA will rely on a single Phase 1 human abuse potential clinical study, bypassing the need for Phase 2 or 3 trials. Aversa Fentanyl combines Nutriband's Aversa technology with an FDA-approved fentanyl patch, developed through a 505(b)(2) NDA pathway.
March 27, 2024 | 9:57 am
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POSITIVE IMPACT
Nutriband's announcement about Aversa Fentanyl's streamlined clinical development and regulatory pathway could positively impact investor sentiment.
The announcement indicates a potentially faster route to market for Aversa Fentanyl, which could lead to earlier revenue generation. The use of a single Phase 1 study instead of multiple clinical trials could reduce development costs and time, positively affecting Nutriband's financial outlook and stock price in the short term.
CONFIDENCE 85
IMPORTANCE 90
RELEVANCE 100