Aquestive resubmits Anaphylm application after FDA rejection

Aquestive ($AQST) Therapeutics resubmitted its US new-drug application for Anaphylm, a sublingual film containing dibutepinephrine for severe allergic reactions, including anaphylaxis. The submission responds to the FDA’s earlier complete response letter and includes additional human-factors and pharmacokinetic information intended to address the agency’s concerns.

Supporting work includes changes to the product’s packaging and evidence that users could open it more quickly. The company previously reported a reduction in median opening time from 17 seconds to three seconds; that study result is background to the new resubmission. The FDA still needs to classify the submission and establish the review timetable. Resubmitting the application does not constitute approval, and any commercial launch remains contingent on a favorable regulatory decision.

Sources:

• Aquestive — Anaphylm resubmission, company release reprint