Aquestive Therapeutics, Inc. has announced a subsequent analysis of the pivotal study of its product candidate Anaplym™ (epinephrine) sublingual film. The analysis demonstrated comparable pharmacokinetics (PK) and pharmacodynamics (PD) data regardless of variable placement or intraoral movement. The poster presentation at the American College of Allergy Asthma and Immunology (ACAAI) annual meeting showcased a subsequent analysis of the previously disclosed pivotal study, which successfully met primary and secondary endpoints.
Results of the pivotal study showed that movement was noted in 12.5% of subjects, with 87.5% of subjects showing no change in film location between 1.5 to 3 minutes after administration of Anaplym. In cases where movement was noted, there were no significant differences in geometric mean maximum concentration (Cmax) or median peak drug concentration (Tmax) between subjects with or without film movement. These findings support that the initial placement or subsequent movement of the sublingual film had no impact on epinephrine PK or PD, with all results comparable to epinephrine injection.
Anaplym™ (epinephrine) sublingual film is a polymer matrix-based epinephrine prodrug product candidate. It is similar in size to a postage stamp, weighs less than an ounce, and begins to dissolve on contact. No water or swallowing is required for administration. The packaging is thinner and smaller than an average credit card, designed to withstand weather excursions, and can be carried in a pocket.
Aquestive Therapeutics is a pharmaceutical company advancing medicines through innovative science and delivery technologies. The company has five commercialized products marketed in the U.S. and around the world and is the exclusive manufacturer of these licensed products. Aquestive is also advancing a late-stage proprietary product candidate for the treatment of severe allergic reactions, including anaphylaxis, and an earlier stage epinephrine prodrug topical gel for various dermatology conditions, including alopecia areata. As a result of these announcements, the company's shares have moved -0.8% on the market, and are now trading at a price of $5.43. For the full picture, make sure to review Aquestive Therapeutics's 8-K report.
