Aquestive Therapeutics, Inc. announced the U.S. Food and Drug Administration (FDA) has conditionally accepted the proprietary name Anaphylm as the proposed brand name for AQST-109, the Company's polymer matrix-based epinephrine prodrug administered as a sublingual film in development for the treatment of severe allergic reactions including anaphylaxis. The proprietary name Anaphylm (pronounced ana-PHYLM) was developed after an extensive process involving external branding experts as well as patient feedback. The ANA portion of the name is derived from anaphylaxis and the PHYLM portion of the name is designed to remind patients and caregivers of the oral film product form.
The Company also completed a research study of healthcare practitioners across the U.S. to promote accurate prescription and safety interpretation of the name. Anaphylm was developed in accordance with FDA's guidance for the submission and evaluation of proprietary names. Final approval of the Anaphylm proprietary name is conditioned on FDA approval of the product candidate, AQST-109.