- Reviews constructive pharmacokinetic (PK) outcomes from the just lately accomplished pediatric research for Anaphylm™
- Completes submission of its New Drug Utility (NDA) for Anaphylm to the FDA; NDA acceptance anticipated in Q2 2025
WARREN, N.J., April 01, 2025 (GLOBE NEWSWIRE) — Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Firm”), a pharmaceutical firm advancing medicines to convey significant enchancment to sufferers’ lives by means of modern science and supply applied sciences, at the moment introduced constructive topline outcomes from its pediatric research for Anaphylm™ (epinephrine) sublingual movie in sufferers aged seven to seventeen and weighing better that thirty kilograms with a private historical past of allergic reactions. This marks the completion of the Anaphylm scientific program and helps the scientific knowledge wanted for the NDA submission. Aquestive has submitted the Anaphylm NDA to the U.S. Meals and Drug Administration (FDA) and expects to obtain potential acceptance of the NDA throughout the second quarter of 2025.
“We’re extraordinarily happy with the constructive outcomes from our pediatric research, which additional validate Anaphylm’s potential because the first-ever sublingual movie and handy therapy possibility for all sufferers with extreme allergic reactions, together with anaphylaxis,” stated Daniel Barber, President and Chief Govt Officer of Aquestive. “These outcomes reveal that Anaphylm maintains its constant PK profile in pediatric sufferers between the ages of seven and seventeen and weighing better than thirty kilograms. These knowledge are an necessary part of the FDA overview course of and will allow Anaphylm to have a label that features this pediatric affected person inhabitants. We proceed to arrange for business readiness and plan to launch Anaphylm within the first quarter of 2026, if accredited by the FDA.”
The pediatric research was a multi-site, single therapy research designed to guage the PK, pharmacodynamics (PD), security, and tolerability of Anaphylm. A complete of thirty-two sufferers accomplished the research. The PK outcomes had been per earlier grownup research. Importantly, Anaphylm was proven to be protected and well-tolerated with no severe antagonistic occasions (SAEs) reported. Determine 1 under compares the pediatric research outcomes to the beforehand introduced pivotal grownup research outcomes.
Determine 1: Geometric imply baseline adjusted epinephrine focus over time after administration of Anaphylm 12mg in pediatric topics (Research AQ109302) in comparison with grownup topics (Research AQ109301B)
About Anaphylm™ (epinephrine) Sublingual Movie
Anaphylm™ (epinephrine) Sublingual Movie is a polymer matrix-based epinephrine prodrug product candidate in growth for the therapy of extreme allergic reactions, together with anaphylaxis. Anaphylm is analogous in dimension to a postage stamp, weighs lower than an oz., and begins to dissolve on contact. No water or swallowing is required for administration. The packaging for Anaphylm is thinner and smaller than a median bank card, might be carried in a pocket, and is designed to face up to climate excursions equivalent to publicity to rain and/or daylight. The Anaphylm commerce title for AQST-109 has been conditionally accredited by the FDA. Ultimate approval of the Anaphylm proprietary title is conditioned on FDA approval of the product candidate.
