The FDA has delayed approval of Aquestive Therapeutics’ new drug application seeking approval of Anaphylm, a sublingual epinephrine film for the treatment of Type 1 allergic reactions, including anaphylaxis.
The agency issued a complete response letter Jan. 30, citing deficiencies limited to packaging, administration and labeling. The FDA raised concerns tied to the product’s human factors validation study, including difficulty opening the pouch and incorrect film placement, which the agency said could pose safety risks if unaddressed.
Aquestive said it has modified the pouch opening, instructions for use and labeling, and plans to conduct a new human factors validation study, according to a Feb. 2 company news release. The FDA also requested a single pharmacokinetics study related to the changes, which the agency indicated could be conducted in parallel. No additional studies or chemistry, manufacturing and controls issues were cited.
The company said it expects to resubmit the application as early as Q3 2026, pending completion of the requested studies and FDA response timelines. Leaders also said it plans to request an urgent “Type-A” meeting with the FDA to discuss the resubmission path forward.
