Hepion's GV104 Prevents Fentanyl-Induced Cardiac Arrest in Simulation of 200 Subjects
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- Hepion Pharmaceuticals reported GV104 prevented every fentanyl-induced cardiac arrest in a simulation involving 200 virtual subjects.
- A single 16 mg nalmefene buccal film provided simulated protection when taken at least 15 minutes before exposure; untreated arrest risk reached 86.5%.
- The FDA reaffirmed the modeling approach but requested revisions to support demonstrating long-term prophylactic protection.
- The results remain simulation predictions, not clinical outcomes; revised analyses could change the predicted onset, duration and degree of protection.
- Remaining work before a new drug application centers on manufacturing controls, with commercial-scale registration batch production planned to begin in 2027.
Disclaimer:
This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Hepion Pharmaceuticals Inc. published the original content used to generate this news brief on October 26, 2026, and is solely responsible for the information contained therein.
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