Aquestive Therapeutics Announces Pivotal Study for Anaphylm (epinephrine) Sublingual Film Successfully Meets Primary and Secondary Endpoints and Provides Clinical Development Update Following FDA Meeting

• Anaphylm meets all predefined primary and secondary pharmacokinetic endpoints
  
• Anaphylm time to maximum concentration (Tmax) is consistently faster than autoinjectors
• Anaphylm 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 of 2024

WARREN, N.J., March 14, 2024 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today released positive topline clinical data from its Phase 3 pivotal pharmacokinetic (PK) clinical study of Anaphylm (epinephrine) Sublingual Film and findings from the FDA Type C meeting. Anaphylm is the Company’s first and only orally administered epinephrine prodrug product candidate under development for the treatment of severe life-threatening allergic reactions, including anaphylaxis.

“We are extremely pleased with the pivotal study results as well as our recent FDA interaction,” said Daniel Barber, President and Chief Executive Officer of Aquestive. “When it comes to treating severe allergic reactions including anaphylaxis, we often hear from clinicians that rapid absorption of epinephrine at the first sign of symptoms is critical. Our pivotal study indicates that Anaphylm is comparable to the leading autoinjectors immediately following administration and our time to maximum concentration, or Tmax, is faster than the leading autoinjectors. We believe this performance is unprecedented among the alternate delivery options under development and are excited at the potential of Anaphylm as the only oral medicine for treatment of severe allergies.”

“In addition, our recent discussions with the FDA remained consistent with our previous interactions,” continued Mr. Barber. “We believe we have a clear understanding of the remaining clinical development steps necessary for a pre-NDA meeting with the FDA in the second half of the year. Our goal continues to be to file our NDA before the end of 2024 following completion of a positive pre-NDA meeting.”