Hepion Pharmaceuticals Receives FDA Feedback Supporting a Path to Demonstrating Prophylactic Protection for GV104 Against Fentanyl-Induced Cardiac Arrest
Hepion Pharmaceuticals reported that expanded modeling and simulations showed a single 16 mg GV104 nalmefene buccal film, taken at least 15 minutes before exposure, prevented every simulated fentanyl-induced cardiac arrest across 200 virtual subjects. The FDA provided written feedback on the July 2026 briefing package, re-affirming the overall approach while requesting revisions to model structure, results presentation, and challenge simulations that the company believes it can address within its existing program.
Key figures
- Drug Name
- GV104 (nalmefene buccal film)
- Phase Of Trial
- Modeling and simulation / pre-NDA 505(b)(2) program
- Dose modeled
- single 16 mg buccal film
- Median onset
- 10 to 15 minutes after dosing
- Protection rate
- 100% of 200 virtual subjects protected at all fentanyl doses modeled
- Lethal dose range
- roughly 2x to 7x pain-relief fentanyl doses
- Pre exposure timing
- at least 15 minutes before exposure
- Untreated cardiac arrest rate
- 86.5%
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