Aquestive reports positive human factors, PK results for Anaphylm epinephrine sublingual film in healthy volunteers

Aquestive Therapeutics reported positive topline results from a human factors validation study and a pharmacokinetic study for Anaphylm sublingual film.

• Results were presented as topline findings now, supporting a planned NDA resubmission in Q3 2026.
• Revised packaging and instructions improved usability in simulated emergency use, addressing issues cited in an FDA complete response letter.
• Self-administration performed comparably to clinician administration in healthy volunteers, supporting real-world use without injection.
• Incorrect placement still produced a clinically meaningful response broadly consistent with injectable epinephrine, strengthening the risk-mitigation case.