Aquestive Therapeutics completes FDA End-of-Phase 2 meeting for AQST-109

Aquestive Therapeutics announced the completion of its End-of-Phase 2 meeting with the U.S. Food and Drug Administration for AQST-109 for the treatment of severe allergic reactions including anaphylaxis. The final EOP2 FDA meeting minutes provided clarity to the Company as to the FDA’s expectations regarding key program areas related to pharmacokinetics, administration and use that should be addressed given the life-threatening condition that may be treated with AQST-109, if approved. The FDA provided clear guidance on its expectation that AQST-109 PK performance be reasonably bracketed between approved injectable epinephrine products with similarity to epinephrine PK via auto-injectors, since autoinjectors are the most commonly used device for self-treatment. From a reference listed product perspective, the FDA urged the Company to utilize multiple approved injectable products to create a bracketing of high and low epinephrine plasma concentrations as well as mean maximum concentration and partial area under the curve within 30 minutes to 60 minutes after dosing with an emphasis on the early timepoints. Based on existing data, Aquestive believes it can achieve this ‘bracketing’ standard in an adequately powered, well-controlled pivotal PK study. The FDA also provided comments on potential issues the Company will need to address in regard to a sublingually delivered product including the impact of any product hold time, the potential for emesis, and the impact of potential mouth conditions such as angioedema. At this time, the Company believes it can provide sufficient data related to administration and use conditions without overall delay to the New Drug Application submission timeline. In addition, the FDA acknowledged that pharmacodynamic parameters following AQST-109 are generally higher than following administration of injectable products, and that the higher PD responses provided some supportive evidence to the PK-driven development program. The FDA further noted that use of these data as supportive evidence of acceptable PK should be accompanied by further characterization to explain similarities or any differences in mechanism of action.