Yahoo · Oct 26, 2026
Hepion Pharmaceuticals Receives FDA Feedback Supporting a Path to Demonstrating Prophylactic Protection for GV104 Against Fentanyl-Induced Cardiac Arrest
\- In a simulation of 200 virtual subjects, a single dose of GV104 (16 mg nalmefene buccal film) taken at least 15 minutes before exposure prevented every potential fentanyl-induced cardiac arrest, at intravenous fentanyl doses known to be lethal in humans -\- FDA re-affirmed the overall approach and provided comments that will improve the Company's ability to "demonstrate long-term prophylactic protection" -\- The FDA comments are an important step in the path leading to an NDA. The Company int

