Aquestive Therapeutics, Inc. (NASDAQ: AQST) has recently revealed positive topline results from its oral allergy syndrome (OAS) challenge study for Anaplym™ (epinephrine) sublingual film. This marks the completion of the final supportive adult study in the Anaplym development program prior to meeting with the U.S. Food and Drug Administration (FDA).
The OAS challenge study, designed as a two-part investigation, enrolled subjects with confirmed OAS into a three-period study. It involved different arms, including Anaplym with allergen exposure, Anaplym without allergen exposure, and adrenalin intramuscular (IM) injection without allergen exposure. The study revealed that after the administration of Anaplym, symptoms began resolving as early as two minutes in some subjects, and fifty percent of all symptoms across all subjects were resolved by five minutes. Importantly, all instances of symptomatic swelling were completely resolved by five minutes after administration.
The study successfully met both primary and secondary endpoints with no significant differences found between Anaplym pharmacokinetic (PK) results in subjects with and without allergen exposure. The time to maximum plasma concentration (Tmax) remained at twelve minutes in subjects with and without allergen exposure following a single dose of Anaplym. Additionally, the maximum plasma concentration (Cmax) was comparable between Anaplym administered with and without allergen exposure. Anaplym was found to be safe and well-tolerated, with all adverse events categorized as mild or moderate and resolving without medical intervention.
Aquestive has requested a pre-New Drug Application (NDA) meeting with the FDA and expects to meet with the FDA in the fourth quarter of 2024. The company remains on track to commence a pediatric study in subjects weighing 30 kgs and above in the fourth quarter of 2024, and to submit an NDA to the FDA in the first quarter of 2025. If approved by the FDA, Aquestive aims to initiate a full product launch of Anaplym in the first quarter of 2026.
Anaplym™ (epinephrine) sublingual film is a polymer matrix-based epinephrine prodrug product candidate, and its trade name has been conditionally approved by the FDA. Aquestive is a pharmaceutical company advancing medicines through innovative science and delivery technologies, with a focus on developing orally administered products to deliver complex molecules, providing novel alternatives to invasive and inconvenient standard of care therapies. The company is also collaborating with pharmaceutical companies to bring new molecules to market using proprietary technologies and has proven drug development and commercialization capabilities.
The market has reacted to these announcements by moving the company's shares -1.1% to a price of $5.31. For the full picture, make sure to review Aquestive Therapeutics's 8-K report.
