FDA Will not Require Advisory Committee Assembly for Aquestive’s Sublingual Epinephrine

• NDA stays on observe for FDA PDUFA purpose date of January 31, 2026
• Business planning continues enabling fast 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 deliver significant enchancment to sufferers’ lives by revolutionary science and supply applied sciences, in the present day introduced that the U.S. Meals and Drug Administration (FDA) has knowledgeable the Firm that an advisory committee assembly will not be required for Anaphylm™ (dibutepinephrine) Sublingual Movie. The Prescription Drug Consumer Payment 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 permitted, folks 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 beneath the tongue.

“We’re inspired that the FDA has decided that an advisory committee assembly will not be required for approval of Anaphylm,” mentioned 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 permitted 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, fast allergic response requiring fast utility of epinephrine, however many sufferers hesitate to make use of epinephrine injections as a consequence of concern of needles. Aquestive Therapeutics’ Anaphylm is the primary sublingual epinephrine movie, providing a device-free, patient-friendly different. Eleven medical research have been accomplished, with 967 administrations in whole (840 single-dose and 127 repeat-dose) for adults and kids 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, may be carried in a pocket, and is designed to face up to climate excursions comparable to publicity to rain and/or daylight. The Anaphylm commerce identify for AQST-109 has been conditionally permitted by the FDA. Closing 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 deliver significant enchancment to sufferers’ lives by revolutionary science and supply applied sciences. We’re creating orally administered merchandise to ship advanced molecules, offering novel alternate options to invasive and inconvenient customary 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 deliver 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 numerous dermatology circumstances. For extra info, go to Aquestive.com and comply with us on LinkedIn.

Ahead-Trying Assertion
Sure statements on this press launch embody “forward-looking statements” throughout the that means of the Non-public Securities Litigation Reform Act of 1995. Phrases comparable to “imagine,” “anticipate,” “plan,” “count on,” “estimate,” “intend,” “could,” “will,” or the unfavourable of these phrases, and related expressions, are meant to establish forward-looking statements. These forward-looking statements embody, however should not restricted to, statements concerning the development and associated timing of our product candidate Anaphylm™ (dibutepinephrine) Sublingual Movie by medical growth and approval by the FDA, together with the next launch of Anaphylm, if permitted by the FDA; that the outcomes of the Firm’s medical research for Anaphylm are enough to assist submission of the NDA for approval of Anaphylm by the FDA; that Anaphylm would be the first and solely oral administration of epinephrine and accepted as a substitute for present requirements of care therapy, if Anaphylm is permitted by the FDA; the development of the Firm’s product candidate AQST-108 by medical growth and regulatory approval by the FDA for attainable numerous dermatology circumstances; the potential advantages our merchandise and product candidates might deliver to sufferers; and enterprise methods, market alternatives, and different statements that aren’t historic details.

These forward-looking statements are primarily based on our present expectations and beliefs and are topic to quite a few dangers and uncertainties that would trigger precise outcomes to vary materially from these described within the forward-looking statements. Such dangers and uncertainties embody, however should not restricted to, dangers related to our growth work, together with any delays or adjustments to the timing, price and success of our product growth actions and medical trials and plans, together with these regarding Anaphylm (together with for pediatric sufferers) and AQST-108; threat of delays in development of the regulatory approval course of by the FDA of our product candidates, together with the submitting of the NDA for AQST-108, or the failure to obtain FDA approval in any respect of Anaphylm and AQST-108; threat of the Firm’s capability to generate enough medical information for approval of our product candidates, together with with respect to our pharmacokinetic and pharmacodynamic comparability submission for FDA approval of Anaphylm; threat of the Firm’s capability to deal with the FDA’s feedback and questions concerning the Firm’s medical trials and the NDA for Anaphylm and different issues of the FDA recognized within the FDA Kind C assembly minutes for Anaphylm, together with the chance that the FDA could require extra medical research for approval of Anaphylm; threat related to the success of any competing merchandise, together with generics; threat related to the event of a gross sales and advertising functionality for commercialization of our product candidates, together with Anaphylm; dangers related to the potential affect on the worth of the Firm of the sale or outlicensing of our product and product candidates, together with Anaphylm; dangers and uncertainties inherent in commercializing a brand new product (together with know-how dangers, monetary dangers, market dangers and implementation dangers and regulatory limitations); threat of enough capital and money sources, together with enough entry to accessible debt and fairness financing, together with beneath our ATM facility, and revenues from operations, to fulfill all of our short-term and longer-term liquidity and money necessities and different money wants, on the occasions and within the quantities wanted, together with to start principal funds beneath our 13.5% Notes in 2026, to fund future medical growth and industrial actions for our product candidates, together with Anaphylm, ought to these product candidates be permitted by the FDA; threat that our manufacturing capabilities will likely be enough to assist demand of our product candidates, if permitted by the FDA, and our licensed merchandise within the U.S. and overseas; threat of eroding market share for Suboxone® and threat as a sunsetting product, which accounts for the substantial a part of our present working income; threat of default of our debt devices; dangers associated to the outsourcing of sure gross sales, advertising and different operational and workers capabilities to 3rd events; threat of the speed and diploma of market acceptance within the U.S. of Anaphylm and our different product candidates, ought to these product candidates be permitted by the FDA, and for our licensed merchandise within the U.S. and overseas; threat of the scale and progress of our product markets; dangers related to failure to adjust to all FDA and different governmental and buyer necessities for our manufacturing amenities; dangers related to mental property rights and infringement claims regarding our merchandise; threat that our patent functions for our product candidates, together with for Anaphylm, won’t be well timed issued, or issued in any respect, by the USA Patent and Trademark Workplace; threat of sudden patent developments; threat of laws and regulatory actions and adjustments in legal guidelines or rules affecting our enterprise together with regarding our merchandise and product candidates and product pricing, reimbursement or entry therefor; threat of lack of vital prospects; dangers associated to claims and authorized proceedings towards Aquestive, together with patent infringement, securities, enterprise torts, investigative, product security or efficacy and antitrust litigation issues; threat of product recollects and withdrawals; dangers associated to any disruptions in our info know-how networks and techniques, together with the affect of cybersecurity assaults; threat of elevated cybersecurity assaults and information accessibility disruptions as a consequence of distant working preparations; threat of opposed developments affecting the monetary providers business; dangers associated to inflation and rising rates of interest; dangers associated to the affect of the COVID-19 international pandemic and different pandemic illnesses on our enterprise; dangers and uncertainties associated to normal financial, political (together with the Ukraine and Israel wars and different acts of conflict and terrorism), enterprise, business, regulatory, monetary and market circumstances and different uncommon gadgets; dangers associated to the uncertainty about presidential administration initiatives and their affect on our enterprise, together with the imposition of tariffs and different commerce restrictions; and different uncertainties affecting us together with these described within the “Danger Components” part and in different sections included within the Firm’s Annual Report on Type 10-Okay, Quarterly Stories on Type 10-Q, and Present Stories on Type 8-Okay filed with the U.S. Securities and Alternate Fee. Given these uncertainties, you shouldn’t place undue reliance on these forward-looking statements, which converse solely as of the date made. All subsequent forward-looking statements attributable to the Firm or any particular person performing on its behalf are expressly certified of their entirety by this cautionary assertion. The Firm assumes no obligation to replace forward-looking statements after the date of this press launch whether or not on account of new info, future occasions or in any other case, besides as could also be required by relevant legislation.