- Information present Anaphylm maintains constant stability and efficiency below excessive temperature and real-world circumstances, together with warmth, freezing, and water submersion
- New findings show dosing of Anaphylm ends in constant epinephrine absorption with out impacting security or pharmacodynamic (PD) parameters
- Anaphylm pharmacokinetic (PK) and PD will not be impacted by oral swelling
- Median symptom decision time was 12 minutes in comparison with 74 minutes with out remedy; imply angioedema symptom decision time was inside 5 minutes.
WARREN, N.J., Feb. 12, 2025 (GLOBE NEWSWIRE) — Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Firm”), a pharmaceutical firm advancing medicines to carry significant enchancment to sufferers’ lives by means of progressive science and supply applied sciences, immediately introduced that a number of shows highlighting outcomes from the investigational use of Anaphylm epinephrine sublingual movie within the remedy of extreme allergic reactions, together with anaphylaxis, shall be featured on the 2025 American Academy of Allergy, Bronchial asthma and Immunology (AAAAI) Annual Assembly. The assembly will happen February 28 – March 3, 2025, in San Diego, CA.
“These newest outcomes reinforce the power of our medical knowledge and the potential of our product candidate Anaphylm as a dependable, transportable, and efficient remedy for anaphylaxis,” mentioned Daniel Barber, Chief Govt Officer of Aquestive. “Anaphylm was designed to supply sufferers a extra accessible choice for emergency epinephrine administration, with out the necessity for an injection or machine, if accredited by the FDA. These knowledge additional show Anaphylm’s efficiency below real-world circumstances in resolving angioedema signs.”
Within the Part 2 open-label Oral Anaphylm Symptom Intervention Examine (“OASIS”) examine, adults with Oral Allergy Syndrome (n=36) obtained Anaphylm below completely different circumstances, together with single and repeat dosing with and with out oral allergen problem (OAC), alongside intramuscular (IM) epinephrine injection as a comparator. The examine discovered that:
- Anaphylm matched or exceeded IM epinephrine in all key PK parameters.
- No important variations in drug efficiency in comparison with IM epinephrine have been noticed, no matter whether or not sufferers had an oral allergen problem or not.
- Median symptom decision time was 12 minutes in comparison with 74 minutes with out remedy; imply angioedema symptom decision time was inside 5 minutes.
Moreover, new findings point out that Anaphylm maintains prior reported high line knowledge in assist of stability and efficiency regardless of publicity to excessive temperatures and environmental circumstances, underscoring its efficiency in real-world settings the place sufferers might have it most.
Poster presentation particulars are as follows:
Poster Title: Sturdiness of Anaphylm (Epinephrine Sublingual Movie) below Actual-World Use
Poster Quantity: 304
Lead Creator: Steve Wargacki, PhD
Presentation Time: Saturday, Mar. 1, 9:45 am – 10:45 am PT
Poster Title: Stability Outcomes of Anaphylm (Epinephrine Sublingual Movie) Underneath Excessive Temperature Circumstances
Poster Quantity: 305
Lead Creator: Steve Wargacki, PhD
Presentation Time: Saturday, Mar. 1, 9:45 am – 10:45 am PT
Poster Title: Epinephrine Delivered through Sublingual Movie (Anaphylm): Pharmacokinetic and Pharmacodynamic Responses
Poster Quantity: 312
Lead Creator: Carl N. Kraus, MD
Presentation Time: Saturday, Mar. 1, 9:45 am – 10:45 am PT
Poster Title: Oral Anaphylm Symptom Intervention Examine (OASIS): Pharmacokinetics, Pharmacodynamics, and Symptom Decision in Allergy Sufferers
Poster Quantity: L18
Lead Creator: Carl N. Kraus, MD
Presentation Time: Saturday, Mar. 1, 9:45 am – 10:45 am PT
The abstracts can be found on-line at annualmeeting.aaaai.org, in addition to on the Firm’s web site on the Scientific occasions web page of the of the Investor part.
About Anaphylm™ (epinephrine) Sublingual Movie
Anaphylm™ (epinephrine) Sublingual Movie is a polymer matrix-based epinephrine prodrug product candidate. Anaphylm is comparable 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 mean bank card, could be carried in a pocket, and is designed to face up to climate excursions resembling publicity to rain and/or daylight. The Anaphylm commerce identify for AQST-109 has been conditionally accredited by the U.S. Meals and Drug Administration (FDA). Remaining 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 carry significant enchancment to sufferers’ lives by means of progressive science and supply applied sciences. We’re growing orally administered merchandise to ship complicated molecules, offering novel options to invasive and inconvenient commonplace of care therapies. Aquestive has 5 commercialized merchandise marketed by the Firm and its licensees within the U.S. and world wide, and is the unique producer of those licensed merchandise. The Firm additionally collaborates with pharmaceutical firms to carry 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 remedy of extreme allergic reactions, together with anaphylaxis, and an earlier stage epinephrine prodrug topical gel product candidate for doable varied dermatology circumstances. For extra data, go to Aquestive.com and comply with us on LinkedIn.
Ahead-Wanting Assertion
Sure statements on this press launch embody “forward-looking statements” throughout the which means of the Personal Securities Litigation Reform Act of 1995. Phrases resembling “consider,” “anticipate,” “plan,” “count on,” “estimate,” “intend,” “might,” “will,” or the unfavorable of these phrases, and comparable expressions, are meant to establish forward-looking statements. These forward-looking statements embody, however will not be restricted to, statements concerning the development and associated timing of our product candidate Anaphylm™ (epinephrine) Sublingual Movie by means of medical growth and approval by the FDA, together with submitting the NDA for Anaphylm with the FDA and the next launch of Anaphylm, if accredited by the FDA; that the outcomes of the Firm’s medical research for Anaphylm are ample to assist submission of the NDA for approval of Anaphylm by the FDA; the development of the Firm’s product candidate AQST-108 by means of medical growth and approval by the FDA for doable varied dermatology circumstances; the potential advantages our merchandise and product candidates might carry to sufferers; and enterprise methods, market alternatives, and different statements that aren’t historic information.
These forward-looking statements are primarily based on our present expectations and beliefs and are topic to quite a few dangers and uncertainties that might trigger precise outcomes to vary materially from these described within the forward-looking statements. Such dangers and uncertainties embody, however will not be 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 referring to Anaphylm (together with for pediatric sufferers) and AQST-108; threat of delays in development of the regulatory approval course of by means of the FDA of our product candidates, together with the submitting of the respective NDAs, together with for Anaphylm and AQST-108, or the failure to obtain FDA approval in any respect of any of those product candidates; threat of the Firm’s means to generate ample medical knowledge 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 means to handle the FDA’s feedback on the Firm’s medical trials and different issues recognized within the FDA Kind C assembly minutes for Anaphylm, together with the chance that the FDA might require extra medical research for approval of Anaphylm; threat of the success of any competing merchandise; dangers and uncertainties inherent in commercializing a brand new product (together with expertise dangers, monetary dangers, market dangers and implementation dangers and regulatory limitations); threat of ample capital and money sources, together with ample entry to accessible debt and fairness financing, together with below our ATM facility and the Lincoln Park Buy Settlement, 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 fund commercialization actions referring to fund future medical growth and industrial actions for our product candidates, together with Anaphylm, ought to these product candidates be accredited by the FDA; 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 marketing and different operational and workers features 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 accredited by the FDA, and for our licensed merchandise within the U.S. and overseas; threat of the success of any competing merchandise together with generics; threat of the dimensions and development of our product markets; threat of compliance with all FDA and different governmental and buyer necessities for our manufacturing services; dangers related to mental property rights and infringement claims referring to our merchandise; threat that our patent purposes for our product candidates, together with for Anaphylm, won’t be well timed issued, or issued in any respect, by the PTO; threat of sudden patent developments; threat of laws and regulatory actions and adjustments in legal guidelines or rules affecting our enterprise together with referring to our merchandise and merchandise candidates and product pricing, reimbursement or entry therefor; threat of lack of important clients; 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 data expertise networks and methods, together with the impression of cybersecurity assaults; threat of elevated cybersecurity assaults and knowledge accessibility disruptions on account of distant working preparations; threat of antagonistic developments affecting the monetary providers business; dangers associated to inflation and rising rates of interest; dangers associated to the impression of the COVID-19 international pandemic and different pandemic illnesses on our enterprise, together with with respect to our medical trials and the positioning initiation, affected person enrollment and timing and adequacy of these medical trials, regulatory submissions and regulatory opinions and approvals of our product candidates, availability of pharmaceutical substances and different uncooked supplies utilized in our merchandise and product candidates, provide chain, manufacture and distribution of our merchandise and product candidates; dangers and uncertainties associated to normal financial, political (together with the Ukraine and Israel wars and different acts of warfare and terrorism), enterprise, business, regulatory, monetary and market circumstances and different uncommon objects; and different uncertainties affecting us together with these described within the “Threat Elements” part and in different sections included within the Firm’s Annual Report on Kind 10-Okay, Quarterly Experiences on Kind 10-Q, and Present Experiences on Kind 8-Okay filed with the U.S. Securities and Trade Fee. Given these uncertainties, you shouldn’t place undue reliance on these forward-looking statements, which communicate solely as of the date made. All subsequent forward-looking statements attributable to the Firm or any individual appearing on its behalf are expressly certified of their entirety by this cautionary assertion. The Firm assumes no obligation to replace forward-looking statements or outlook or steering after the date of this press launch whether or not on account of new data, future occasions or in any other case, besides as could also be required by relevant regulation.
PharmFilm® and the Aquestive emblem are registered logos of Aquestive Therapeutics, Inc. All different registered logos referenced herein are the property of their respective homeowners.
Investor Contact:
Brian Korb
astr companions
brian.korb@astrpartners.com
A Dialog About Sublingual Epinephrine
