Company Initiates Pivotal Study for Epinephrine Nasal Powder, Targets 2027 NDA Filing
What happened
Belhaven Biopharma, Inc. announced the initiation of a pivotal clinical study evaluating BBP01, an investigational nasal powder formulation of epinephrine. The randomized, open-label, three-treatment crossover study compares BBP01 against established intramuscular epinephrine auto-injectors and manual injections. The company stated this study will generate the definitive data needed for a pre-NDA meeting with the FDA in the first quarter of 2027.
From finanznachrichten.de
Why it matters
The successful completion of the study and subsequent FDA review could pave the way for a New Drug Application filing in 2027. The product is being developed as a needle-free alternative for the delivery of epinephrine to treat anaphylaxis.
From finanznachrichten.de
Who's involved
- FDARecipient of the definitive data for the potential New Drug Application
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The entities involved
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FDA
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- Matricelf Ltd. is seeking feedback from the FDA regarding its clinical trial design. The company is currently listed on the Tel Aviv Stock Exchange with plans for a dual listing to support its transition.
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Raleigh
city in and state capital of North Carolina, United States of America
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