NEWS
Aquestive Therapeutics Announces Positive Topline Results from Oral Allergy Syndrome (OAS) Challenge Study for Anaphylm™ (epinephrine) Sublingual Film
Aquestive Therapeutics (NASDAQ: AQST) announced positive topline results from its Oral Allergy Syndrome (OAS) challenge study for Anaphylm™ sublingual film. The study met both primary and secondary endpoints, demonstrating rapid symptom resolution beginning two minutes after administration. The median time for complete symptom resolution was twelve minutes, significantly faster than the 74-minute baseline. The pharmacokinetic profile remained consistent with previous studies, showing a 12-minute time to maximum plasma concentration. The company plans a pre-NDA meeting with FDA in Q4 2024, aims to submit an NDA in Q1 2025, and targets product launch in Q1 2026.
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