FDA accepts Aquestive's Anaphylm NDA resubmission, sets March 2027 PDUFA date

Aquestive Therapeutics announced on October 15, 2026 that the FDA had acknowledged the resubmission of its New Drug Application for Anaphylm (dibutepinephrine) sublingual film as complete. The FDA classified the resubmission as a Class 2 response and set a Prescription Drug User Fee Act goal date of March 16, 2027.¹ Anaphylm is intended to treat Type I allergic reactions, including anaphylaxis.

If approved, Anaphylm would be the first and only oral rescue medication for severe allergic reactions, including anaphylaxis, according to the company.¹

The resubmission followed a Complete Response Letter the FDA issued on January 30, 2026. Aquestive filed the resubmission on September 16, 2026, after reporting positive topline results in August 2026 from human factors and pharmacokinetic studies meant to address the issues raised in that letter.¹

CEO Daniel Barber said the FDA's acceptance of the resubmission and the Class 2 PDUFA classification gives the company a clear path forward for Anaphylm, as expected.¹ He added that the company intends to work with the FDA to complete the review on or before the assigned goal date.¹

Outside the United States, Aquestive said it remains on track to file a New Drug Submission for Anaphylm with Health Canada during the fourth quarter of 2026.¹

The company described Anaphylm as a polymer matrix-based epinephrine prodrug product candidate¹ and noted that the FDA has conditionally approved the Anaphylm trade name for AQST-109, with final approval contingent on approval of the product itself.¹ Aquestive is based in Warren, New Jersey, and trades on Nasdaq under the ticker AQST.