Aquestive Therapeutics Announces Pivotal Study for Anaphylm™ (epinephrine) Sublingual Film Successfully Meets Primary and Secondary Endpoints and Provides Clinical Development Update Following FDA Meeting
Aquestive(AQST) Newsfilter·2024-03-14 21:23Anaphylm meets all predefined primary and secondary pharmacokinetic endpointsAnaphylm time to maximum concentration (Tmax) is consistently faster than autoinjectorsAnaphylm exposure levels (AUC) are comparable to autoinjectors for 30 minutes after dosing Anaphylm is well-tolerated with no serious adverse events Company receives positive Type C meeting feedback from the U.S. Food and Drug Administration (FDA) regarding the clinical development of Anaphylm Company reaffirms goal of filing NDA before the end o ...