- Preliminary placement or subsequent motion of Anaphylm confirmed no affect on epinephrine pharmacokinetics (PK) or pharmacodynamics (PD), with all outcomes akin to epinephrine injection
- Information demonstrates Anaphylm gives a constant and permissive methodology of drug supply in anaphylaxis administration
WARREN, N.J., Oct. 25, 2024 (GLOBE NEWSWIRE) — Aquestive Therapeutics , Inc. (NASDAQ:) (“Aquestive” or the “Company”), a pharmaceutical firm advancing medicines to deliver significant enchancment to sufferers’ lives via progressive science and supply applied sciences, in the present day introduced {that a} subsequent evaluation of the information from the pivotal research of its product candidate Anaphylm™ (epinephrine) Sublingual Movie demonstrating comparable PK and PD knowledge no matter variable placement or intraoral motion will likely be offered on the American Faculty of Allergy Bronchial asthma and Immunology (ACAAI) annual assembly, which is being held from October 24-28 in Boston, Massachusetts.
“The poster, detailing a subsequent analysis of the data from the pivotal study of Anaphylm, being presented at ACAAI this year marks an important milestone in our development of Anaphylm, as it demonstrates the robustness and reliability of our sublingual film technology,” mentioned Dan Barber, Aquestive’s President and Chief Government Officer. “These findings show that our innovative PharmFilm™ delivery system maintains consistent pharmacokinetics and pharmacodynamics regardless of minor variations in placement, providing further evidence of Anaphylm’s potential to offer healthcare providers and patients a dependable alternative for the treatment of severe allergic reactions. Anaphylm has the potential to be the first and only FDA-approved no-needle, no-device, oral epinephrine product for treating severe allergic reactions, including anaphylaxis, if approved by the FDA.”
The poster presentation will showcase a subsequent evaluation of the beforehand disclosed pivotal research that efficiently met major and secondary endpoints, discovered on the hyperlink right here. The following evaluation was performed to judge the affect of intraoral movie placement and motion on variability in PK and PD. Motion was famous in 12.5% of topics (8 of 64). Outcomes of the pivotal research demonstrated constant drug supply, with 87.5% of topics exhibiting no change in movie location between 1.5 to three minutes after administration of Anaphylm. In circumstances the place motion was famous, there have been no vital variations between topics with or with out movie motion in geometric imply most focus, or Cmax (351.14 and 490.27 pg/mL, respectively), or median peak drug focus, or Tmax (12 minutes for each teams). These findings help that the preliminary placement or subsequent motion of the sublingual movie had no affect on epinephrine PK or PD, with all outcomes akin to epinephrine injection.
Presentation Particulars:
Summary Sublingual Epinephrine Movie’s Mucoadhesive Properties Ensures Constant Oral Placement and Drug Launch
Summary ID: 8103
ePoster ID: R008
Presentation Time: Friday, October 25, 2024, 3:45 PM ET
Location: Monitor 16, Exhibit Corridor A, Hynes Conference Heart
The poster can be found on-line for registered individuals of the assembly at annualmeeting.acaai.org, and also will be obtainable on the Occasions and Displays web page of the Investor Part of the Firm’s web site following the presentation.
About Anaphylm™
Anaphylm™ (epinephrine) Sublingual Movie is a polymer matrix-based epinephrine prodrug product candidate. Anaphylm is analogous 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 a median bank card, may be carried in a pocket, and is designed to resist climate excursions corresponding to publicity to rain and/or daylight. The Anaphylm commerce identify for AQST-109 has been conditionally authorised 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 via progressive science and supply applied sciences. We’re growing orally administered merchandise to ship advanced molecules, offering novel options to invasive and inconvenient customary of care therapies. Aquestive has 5 commercialized merchandise marketed by the Firm and its licensees within the U.S. and around the globe, 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 remedy of extreme allergic reactions, together with anaphylaxis, and an earlier stage epinephrine prodrug topical gel for varied dermatology situations together with Alopecia areata. 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 inside the which means of the Personal Securities Litigation Reform Act of 1995. Phrases corresponding to imagine, anticipate, plan, anticipate, estimate, intend, might, will, or the destructive of these phrases, and related expressions, are supposed to determine forward-looking statements. These forward-looking statements embody, however are usually not restricted to, statements relating to the development and associated timing of our product candidate Anaphylm™ (epinephrine) Sublingual Movie via medical growth and approval by the FDA, the potential advantages Anaphylm may deliver to sufferers, 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 numerous 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 are usually 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); threat of delays in development of the regulatory approval course of via the FDA of our product candidates, together with the submitting of the respective NDAs, together with for Anaphylm, or the failure to obtain FDA approval in any respect of any of those product candidates; threat of the Firm’s skill to generate ample medical knowledge for approval of our product candidates, together with with respect to our PK and PD comparability submission for FDA approval of Anaphylm; threat of the Firm’s skill to deal with 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 danger that the FDA might require further medical research for approval of 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 ample capital and money sources, together with ample entry to obtainable debt and fairness financing, together with underneath our A™ 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 instances and within the quantities wanted, together with to fund commercialization actions regarding fund future medical growth and business actions for our product candidates, together with Anaphylm, ought to these product candidates be authorised 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 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 authorised 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 regarding 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 U.S. Patent and Trademark Workplace; threat of surprising patent developments; threat of laws and regulatory actions and adjustments in legal guidelines or rules affecting our enterprise together with regarding our merchandise and merchandise candidates and product pricing, reimbursement or entry therefor; threat of lack of vital clients; dangers associated to claims and authorized proceedings in opposition to 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 methods, together with the affect of cybersecurity assaults; threat of elevated cybersecurity assaults and knowledge accessibility disruptions on account of distant working preparations; threat of hostile 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 ailments on our enterprise, together with with respect to our medical trials and the location initiation, affected person enrollment and timing and adequacy of these medical trials, regulatory submissions and regulatory evaluations and approvals of our product candidates, availability of pharmaceutical components 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 common financial, political (together with the Ukraine and Israel wars and different acts of warfare and terrorism), enterprise, business, regulatory, monetary and market situations and different uncommon objects; and different uncertainties affecting us together with these described within the “Risk Factors” part and in different sections included within the Firm’s Annual Report on Kind 10-Ok, Quarterly Stories on Kind 10-Q, and Present Stories on Kind 8-Ok 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 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 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 regulation.
PharmFilm ® and the Aquestive emblem are registered emblems of Aquestive Therapeutics, Inc. All different registered emblems referenced herein are the property of their respective homeowners.
Investor Inquiries:
ICR Healthcare
Stephanie Carrington
stephanie.carrington@icrhealthcare.com
646-277-1282
