WARREN, NJ, April 20, 2023 (GLOBE NEWSWIRE) — Aquestive Therapeutics, Inc. (NASDAQ: AQST) (the Firm or Aquestive), a pharmaceutical firm that advances medicines to resolve affected person issues with present requirements of care and supply transformative merchandise to enhance their lives, at the moment introduced that the U.S. Meals and Drug Administration (FDA) has conditionally accepted the proprietary title Anaphylm because the proposed model title for AQST-109, the prodrug of The Firm’s polymer matrix epinephrine administered as a sublingual movie in growth for the remedy of extreme allergic reactions, together with anaphylaxis.
The proprietary title Anaphylm (pronounced ana-PHYLM) was developed after an intensive course of involving exterior branding specialists in addition to affected person suggestions. The ANA a part of the title is derived from anaphylaxis and the PHYLM a part of the title is designed to remind sufferers and caregivers of the oral movie kind. The corporate additionally carried out a analysis examine with healthcare professionals throughout the US to advertise correct interpretation of prescribing and title security. Anaphylm was developed in accordance with FDA pointers for model title submission and analysis. Closing approval of the Anaphylm model title is contingent upon FDA approval of the product candidate, AQST-109.
We’re happy that the FDA has conditionally accepted the Anaphylm title for AQST-109, mentioned Daniel Barber, CEO of Aquestive. That is yet one more vital step in direction of making Anaphylm obtainable to sufferers. In line with the literature, nearly half of sufferers mentioned they didn’t have their auto-injector with them throughout a extreme allergic response and even when it’s obtainable it’s typically not used for causes resembling needle phobia. We consider altering this paradigm begins with enhancing how sufferers and caregivers work together with their prescribed product. Conditionally marking AQST-109 as an anaphylma is simply one of many steps we’re taking to scale back boundaries to affected person use.
Anaphylaxis is a extreme systemic hypersensitivity response that’s fast onset and probably deadly. As many as 49 million individuals in the US are at continual danger for anaphylaxis. The reported incidence of anaphylaxis in the US is 49.8 per 100,000 person-years, with a prevalence of roughly 1.6% to five.1%. The direct prices of anaphylaxis have been estimated at $1.2 billion per 12 months, with direct expenditures of $294 million for epinephrine and oblique prices of $609 million. The frequency of hospitalizations for anaphylaxis has elevated by 500-700% over the previous 1015 years. 52% of sufferers with a historical past of anaphylaxis had by no means been prescribed an epinephrine auto-injector and 60% didn’t have an auto-injector presently obtainable. The commonest causes of anaphylaxis are meals (resembling peanuts), venom from insect bites, and medicines. Epinephrine injection is the present customary of remedy supposed to reverse the extreme manifestation of anaphylaxis, which may embrace pores and skin rash, throat swelling, respiration issues, gastrointestinal misery, and lack of consciousness .
With reference to Anaphylm
Anaphylm (AQST-109) is a polymer matrix-based epinephrine prodrug product candidate delivered as a sublingual movie that’s utilized underneath the tongue for the fast supply of epinephrine. The product 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. Anaphylm’s packaging is thinner and smaller than the common bank card, will be carried in a pocket, and is designed to be climate resistant resembling publicity to rain and/or solar.
About Aqueous Therapeutics
Aquestive Therapeutics, Inc. (NASDAQ: AQST) is a pharmaceutical firm that advances medicines to resolve affected person issues with at the moment’s requirements of care and ship transformative merchandise to enhance their lives. We’re growing orally administered merchandise to ship advanced molecules, providing new options to invasive and impractical customary therapies. Aquestive has 5 merchandise marketed by our licensees in the US and all over the world. The Firm additionally collaborates with pharmaceutical firms to carry new molecules to market utilizing superior proprietary applied sciences, resembling PharmFilm, and has confirmed drug growth and commercialization capabilities. Aquestive is advancing a late-stage proprietary product pipeline targeted on treating central nervous system ailments and an early-stage pipeline for the remedy of extreme allergic reactions, together with anaphylaxis. For extra data, go to Aquestive.com and comply with us on LinkedIn.
Sure statements on this press launch embrace forward-looking statements throughout the that means of the Personal Securities Litigation Reform Act of 1995. and comparable expressions, are supposed to establish forward-looking statements. These forward-looking statements embrace, however aren’t restricted to, statements relating to the potential advantages that Anaphylm may carry to sufferers, that the Anaphylm model title will promote correct prescribing and security interpretation by healthcare prescribers. well being, and different statements that aren’t historic information. These forward-looking statements are topic to the unsure impression of the worldwide COVID-19 pandemic on the Firm’s enterprise, together with with respect to its medical trials, together with website initiation, enrollment and timing and the adequacy of medical trials; on regulatory submissions and regulatory evaluations and approval of Anaphylm; provide chain, manufacturing and distribution of pharmaceutical elements and different uncooked supplies; and the continued availability of an acceptable workforce and expert professionals.
These forward-looking statements are primarily based on the Firm’s present expectations and beliefs and are topic to quite a lot of dangers and uncertainties that would trigger precise outcomes to vary materially from these described within the forward-looking statements. These dangers and uncertainties embrace, however aren’t restricted to, dangers related to the corporate’s growth work, together with any delays or adjustments within the timing, value and success of its product growth actions and medical trials for Anaphylm; the danger that the corporate might not generate adequate information in its PK/PD comparability submission for FDA approval of Anaphylm; the danger that the corporate won’t deal with the considerations recognized on the FDA Part 2 end-of-phase assembly for Anaphylm; danger of delay or failure to acquire FDA approval for Anaphylm; danger of inadequate capital and money assets, together with inadequate entry to obtainable debt and fairness financing and working revenue, to satisfy all short-term and long-term liquidity and money necessities of the Firm and different money necessities, on the instances and within the quantities required; uncertainties associated to normal financial, political, enterprise, business, regulatory and market circumstances and different uncommon objects; and different dangers and uncertainties affecting the Firm described within the Danger Components part and in different sections included in its Annual Report on Type 10-Ok, its Quarterly Studies on Type 10-Q and its Present Studies on Type 8-Ok filed with the 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 undertakes no obligation to replace any forward-looking statements, 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 required by regulation. relevant so requires.
PharmFilm and the Aquestive emblem are registered logos of Aquestive Therapeutics, Inc.