Oragenics Inc. announced on October 8, 2024, the successful completion of a key FDA-recognized intranasal casting study for its concussion drug, ONP-002. The study demonstrated that the drug successfully targets the interior nose, which is directly linked to the brain.
Intranasal casting studies are valued by the FDA for pharmaceuticals delivered via the nasal passage and are accepted in FDA submissions. The results indicate that ONP-002 is more likely to reach and treat the brain quickly after a concussion, reducing the likelihood of it being swallowed.
This promising outcome supports Oragenics' preparation for its Phase II study, where it aims to administer the first dose of ONP-002 within eight hours of injury. The study reinforces the potential effectiveness of the intranasal delivery system for concussion treatment.
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