Aquestive Therapeutics Receives FDA Complete Response Letter for Anaphylm, Citing Packaging & Administration Deficiencies

summarizeSummary

Aquestive Therapeutics received a Complete Response Letter (CRL) from the FDA for its Anaphylm NDA, citing deficiencies related to packaging and administration, but expects to resubmit in Q3 2026 after addressing the issues.

check_boxKey Events

• FDA Issues Complete Response Letter (CRL) for Anaphylm NDA

  Aquestive Therapeutics received a CRL from the FDA on January 30, 2026, for its Anaphylm™ (dibutepinephrine) Sublingual Film NDA, delaying potential approval.

• Deficiencies Limited to Packaging and Administration

  The CRL cited issues with the human factors validation study, specifically regarding difficulty opening the pouch and incorrect film placement, but no concerns were raised about clinical efficacy, safety, or CMC.

• Company Plans Q3 2026 Resubmission

  Aquestive intends to modify packaging and labeling, conduct new human factors and pharmacokinetics studies, and expects to resubmit the NDA in Q3 2026, requesting rapid review.

• Advancing Global Regulatory Strategy

  The company continues its global expansion strategy, with plans to submit for regulatory approval in Canada and Europe in the second half of 2026, following positive feedback from the EMA.

auto_awesomeAnalysis

Aquestive Therapeutics announced receipt of a Complete Response Letter (CRL) from the FDA for its New Drug Application (NDA) for Anaphylm. This follows the previous disclosure on January 9, 2026, regarding identified deficiencies. The CRL specifically cited issues with the human factors (HF) validation study related to packaging and administration, including difficulty opening the pouch and incorrect film placement. Importantly, the FDA did not raise concerns regarding the clinical efficacy, safety, or Chemistry, Manufacturing, and Controls (CMC) data. The company plans to address these deficiencies by modifying packaging and labeling, conducting a new HF validation study, and a single pharmacokinetics (PK) study. Aquestive anticipates resubmitting the NDA in Q3 2026 and will request an expedited review. While a CRL represents a delay in market entry, the company's confidence in rapidly resolving the issues and the limited scope of the deficiencies (not related to the drug's core efficacy or safety) are mitigating factors. The company also continues to advance its global regulatory strategy for Anaphylm, with plans for submissions in Canada and Europe in the second half of 2026, having received positive feedback from the European Medicines Agency (EMA).