Aquestive Therapeutics, Inc. announced on October 15, 2026, that the U.S. Food and Drug Administration (FDA) has acknowledged the company's resubmission of the New Drug Application (NDA) for Anaphylm (dibutepinephrine) sublingual film as complete. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 16, 2027, classifying the resubmission as a Class 2 response.
The NDA resubmission was submitted on September 16, 2026, following the August 2026 announcement of positive topline results from human factors and pharmacokinetic studies. These studies were conducted to address the items raised in the FDA’s Complete Response Letter dated January 30, 2026. The company stated that if approved, Anaphylm would be the first and only oral rescue medication for the treatment of severe allergic reactions, including anaphylaxis.
Aquestive noted that the product candidate is a polymer matrix-based epinephrine prodrug similar in size to a postage stamp and weighs less than an ounce. The packaging is designed to be thinner and smaller than an average credit card and can be carried in a phone or wallet. The company also confirmed that its ex-U.S. regulatory strategy remains on track, with a New Drug Submission to Health Canada planned for the fourth quarter of 2026.
