AQST - Aquestive Therapeutics Reports Positive Topline Phase 3 Clinical Data

2024-03-14 18:32:04 ET

DENVER, Colo., Mar 14, 2024 ( 247marketnews.com )- Aquestive Therapeutics, Inc. (NASDAQ: AQST ) released positive topline clinical data from its Phase 3 pivotal pharmacokinetic (PK) clinical study of Anaphylm (epinephrine), 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, and findings from the FDA Type C meeting.

Anaphylm’s exposure levels are comparable to autoinjectors for 30 minutes after dosing, while meeting all predefined primary and secondary pharmacokinetic endpoints, and consistently well tolerated with no SAEs.

Aquestive reported receiving positive FDA Type C meeting, regarding the clinical development of Anaphylm, and reaffirmed its goal of filing NDA before the end of 2024

“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.”

David Golden, M.D., an allergy-immunology consultant at Sinai Hospital of Baltimore and Franklin Square Hospital in Baltimore, said, “The data from the Anaphylm pivotal study build on the compelling data generated from the prior Anaphylm pilot studies. These latest study results show that the sublingual administration of epinephrine provides rapid and sustained levels of epinephrine similar to approved treatments. Anaphylm is a promising needle-free alternative to the current standard of care, allowing patients to easily carry and administer this life-saving medication.”

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