Children with Meals Allergic reactions is sharing this press launch from Aquestive Therapeutics to convey you the most recent meals allergy information.
Aquestive Therapeutics shared an necessary replace about their new drug, Anaphylm. The Meals and Drug Administration (FDA) informed the corporate that the epinephrine sublingual (under-the-tongue) movie won’t should be reviewed by an advisory committee earlier than deciding if they’ll approve it. The FDA remains to be anticipated to resolve by Jan. 31, 2026.
Anaphylm is a skinny movie containing epinephrine that dissolves below the tongue which is being developed to make use of for treating a extreme allergic response known as anaphylaxis. If accepted, it might be one other needle-free strategy to take epinephrine.
Be taught extra about out there epinephrine choices.
[PRESS RELEASE]
- NDA stays on observe for FDA PDUFA purpose date of January 31, 2026
- Industrial planning continues enabling speedy launch following approval
WARREN, N.J., Sept. 04, 2025 (GLOBE NEWSWIRE) — Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Firm”), a pharmaceutical firm advancing medicines to convey significant enchancment to sufferers’ lives via modern science and supply applied sciences, at this time introduced that the U.S. Meals and Drug Administration (FDA) has knowledgeable the Firm that an advisory committee assembly is just not required for Anaphylm™ (dibutepinephrine) Sublingual Movie. The Prescription Drug Person Charge Act (PDUFA) goal motion date for Anaphylm stays January 31, 2026.
Anaphylm has the potential to be the primary and solely FDA-approved, non-invasive, orally delivered epinephrine product for the therapy of extreme allergic reactions, together with anaphylaxis. If accepted, individuals in danger for extreme allergic reactions would have a device-free, needle-free epinephrine choice. Comparable in measurement to a postage stamp, Anaphylm is run as a skinny, dissolvable movie positioned below the tongue.
“We’re inspired that the FDA has decided that an advisory committee assembly is just not required for approval of Anaphylm,” stated Dan Barber, President and CEO of Aquestive Therapeutics. “Our device-free, sublingual epinephrine movie, is designed to supply sufferers and caregivers a substitute for conventional auto-injectors and different rising non-invasive choices. If accepted by the FDA, we imagine Anaphylm would mark a significant development in anaphylaxis therapy. We’re well-positioned for launch and, primarily based on our current $160 million in financing actions, we may have the power to make sure broad outreach to healthcare suppliers, caregivers, and sufferers following FDA approval.”
Anaphylaxis is a extreme, speedy allergic response requiring rapid utility of epinephrine, however many sufferers hesitate to make use of epinephrine injections resulting from worry of needles. Aquestive Therapeutics’ Anaphylm is the primary sublingual epinephrine movie, providing a device-free, patient-friendly various. Eleven medical research have been accomplished, with 967 administrations in complete (840 single-dose and 127 repeat-dose) for adults and youngsters over 30 kg. The event program additionally features a novel trial for oral allergy syndrome demonstrating Anaphylm’s real-world effectiveness.
About Anaphylm™ (dibutepinephrine) Sublingual Movie
Anaphylm™ (dibutepinephrine) Sublingual Movie is a polymer matrix-based epinephrine prodrug product candidate. Anaphylm is comparable in measurement 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 the typical bank card, could be carried in a pocket, and is designed to face up to climate excursions akin to publicity to rain and/or daylight. The Anaphylm commerce identify for AQST-109 has been conditionally accepted by the FDA. Last approval of the Anaphylm proprietary identify is conditioned on FDA approval of the product candidate.
About Aquestive Therapeutics
Aquestive is a pharmaceutical firm advancing medicines to convey significant enchancment to sufferers’ lives via modern science and supply applied sciences. We’re growing orally administered merchandise to ship advanced molecules, offering novel options to invasive and inconvenient commonplace of care therapies. Aquestive has 4 commercialized merchandise marketed by its licensees within the U.S. and all over the world, and is the unique producer of those licensed merchandise. The Firm additionally collaborates with pharmaceutical firms to convey new molecules to market utilizing proprietary, best-in-class applied sciences, like PharmFilm®, and has confirmed drug growth and commercialization capabilities. Aquestive is advancing a late-stage proprietary product candidate for the therapy of extreme allergic reactions, together with anaphylaxis, and an earlier stage epinephrine prodrug topical gel product candidate for attainable varied dermatology situations. For extra info, go to Aquestive.com and observe us on LinkedIn.
Investor Contact:
Brian Korb
astr companions
brian.korb@astrpartners.com
