FDA Accepts Resubmission of Anaphylm, a Sublingual Epinephrine Film, With a March 16, 2027 Decision Date
Aquestive Therapeutics of Warren, New Jersey, announced on October 15 that the U.S. Food and Drug Administration has accepted its resubmission of the New Drug Application for Anaphylm (dibutepinephrine) sublingual film as complete, assigning a Prescription Drug User Fee Act (PDUFA) goal date of March 16, 2027. The film is intended to treat Type I allergic reactions, including anaphylaxis; if approved, it would be the first and only oral rescue medication for severe allergic reactions.
Anaphylm is a film about the size of a postage stamp, weighing less than an ounce. It begins to dissolve on contact, requiring no water or swallowing, and its packaging is thinner and smaller than a credit card, designed to be carried in a phone case or wallet. Epinephrine is the standard emergency treatment for severe allergic reactions and is currently delivered mainly by auto-injector.
The path to this point has had one setback: the FDA issued a Complete Response Letter on January 30, 2026. Aquestive announced positive topline results from human factors and pharmacokinetic studies in August and resubmitted the application on September 16; the FDA classified the resubmission as a Class 2 response. President and CEO Daniel Barber said the acceptance and goal date give Anaphylm "a clear path forward," and that the company is advancing commercial preparations while remaining on track to file a New Drug Submission with Health Canada in the fourth quarter of 2026.
(Source: Aquestive Therapeutics)
Source: Aquestive Therapeutics
Published by GSM · USA (original Chinese edition)
Photo: 美国食品药品监督管理局（FDA）位于马里兰州银泉市白橡树园区的办公楼。图片来源：Wikimedia Commons，美国FDA官方照片，公共领域
