Aquestive Therapeutics Announces Pivotal Study for Anaphylm™ (epinephrine) Sublingual Film Successfully Meets Primary and Secondary Endpoints and Provides Clinical Development Update Following FDA Meeting
“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.
- “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.
- “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.
- These latest study results show that the sublingual administration of epinephrine provides rapid and sustained levels of epinephrine similar to approved treatments.
- The FDA noted that substantial progress had been made in the Anaphylm clinical development program and did not outline any new clinical development requirements.