Aquestive Therapeutics’ Anaphylm meets endpoints in Phase 3 allergy study

Aquestive Therapeutics released positive topline clinical data from its Phase 3 pivotal pharmacokinetic clinical study of Anaphylm Sublingual Film and findings from the FDA Type C meeting. Anaphylm is the company’s first and only orally administered epinephrine prodrug product candidate under development for the treatment of severe life-threatening allergic reactions, including anaphylaxis. The primary endpoint was to compare the PK of epinephrine following the single administration of Anaphylm to the single administration of Adrenalin and autoinjectors in healthy adult subjects. The secondary endpoints included evaluating PK sustainability following repeat administration and the safety and tolerability following single and repeat administrations vs. epinephrine. Anaphylm time to maximum concentration was consistently faster than autoinjectors and its exposure levels were comparable to autoinjectors for 30 minutes after dosing. Anaphylm was consistently well tolerated with no SAEs. The company also completed a Type C meeting with the FDA in which the FDA indicated that the company has “adequately addressed” the FDA’s previous concerns by removing product hold time from the administration instructions and provided additional information on how to characterize emesis in the Company’s NDA submission. The company will execute this study in Q2. This study will replace the cpreviously planned angioedema study. The FDA reserved judgement on the sufficiency of the Anaphylm clinical development program until completion of ongoing and planned studies, the results of which are expected to be presented at the pre-NDA meeting. The next anticipated meeting with the FDA is the pre-NDA meeting targeted for the second half of 2024. Aquestive’s goal is to file the NDA with the FDA before year end 2024.