Aquestive Therapeutics reaffirms Q4 Anaphylm Phase 3 study start

Aquestive Therapeutics provided a business update on its lead pipeline programs and base business results. The Company recently received comments from the U.S. Food and Drug Administration on its pivotal Phase 3 pharmacokinetic clinical study protocol for Anaphylm Sublingual Film. Anaphylm is a polymer matrix-based epinephrine prodrug administered as a sublingual film that is applied under the tongue for the rapid delivery of epinephrine. Anaphylm comes in a highly portable package with the durability to withstand many of the norms of daily life. In its comments, the FDA indicated that the Company’s proposed endpoints, sample size, and statistical analysis are reasonable. As anticipated, the FDA also reminded the Company that PK sustainability post-dosing is an important factor and recommended using repeat-dose data to support PK sustainability. The Company has incorporated the FDA’s feedback into its upcoming studies and remains on track to start the pivotal Phase 3 study in the fourth quarter 2023. As previously announced, the Company’s NDA for approval of Libervant for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity in patients between two and five years of age was recently accepted for review by the FDA. Diastat Rectal Gel is the only approved treatment currently available to this patient population for this indication. Based on the latest information available to the Company, the review for this NDA remains on track and there are currently no outstanding information requests from the FDA. The NDA for Libervant has a PDUFA assignment date of April 28, 2024. In addition, the Company’s base business continues to generate strong results. Based on preliminary third quarter 2023 results and binding supply purchase orders, the Company anticipates increasing current full-year 2023 guidance for revenue and decreasing full-year guidance for non-GAAP-adjusted EBITDA loss. Updated guidance will be provided during the Company’s third quarter earnings call in early November.