Home Food Allergies Aquestive’s Sublingual Emergency Epinephrine Compares Favorably to EpiPen® in Section 2 Trial

Aquestive’s Sublingual Emergency Epinephrine Compares Favorably to EpiPen® in Section 2 Trial


This morning, Aquestive Therapeutics — a pharmaceutical firm primarily based in Warren, NJ — introduced the topline outcomes from their section 2 EPIPHAST research which sought to match the efficacy of their AQST-109 sublingual movie to the EpiPen.

Amongst different key research metrics, the corporate introduced:

  • The median time for AQST-109 to achieve the utmost focus (often called Tmax) was 12 minutes, considerably sooner than EpiPen’s Tmax of twenty-two.5 minutes;
  • A repeat dose of AQST-109 supplied considerably greater drug plasma concentrations with a Tmax of 8 minutes after administration;
  • Adjustments in systolic blood stress and coronary heart price have been related after a single dose of AQST-109 when in comparison with a single dose of EpiPen.

See their press launch in its entirety beneath. You can even view their Company Investor slide present which describes AQST-109 right here.

  • AQST-109 median time to most focus (Tmax) of 12 minutes was sooner than EpiPen® Tmax of twenty-two.5 minutes
  • AQST-109 repeat dosing supplied considerably greater drug plasma concentrations with a Tmax of 8 minutes after administration
  • Adjustments in systolic blood stress and coronary heart price have been related after a single dose of AQST-109 when in comparison with a single dose of EpiPen
  • Finish-of-Section 2 assembly with FDA scheduled for fourth quarter 2022 and remaining scientific research will begin thereafter
  • Firm hosts convention name at 8:00 am ET on September 27, 2022

WARREN, N.J., Sept. 27, 2022 (GLOBE NEWSWIRE) — Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical firm advancing medicines to unravel sufferers’ issues with present requirements of care and supply transformative merchandise to enhance their lives, at present introduced constructive topline outcomes from the EPIPHAST II trial for its AQST-109 epinephrine sublingual movie.

“Pace issues in delivering systemic epinephrine throughout an anaphylaxis occasion. Any delay may end up in extreme bronchospasm, acute respiratory failure and/or cardiovascular collapse, in addition to much less favorable outcomes and demise,” mentioned David Bernstein, MD, College of Cincinnati. “AQST-109 continues to show quick supply of therapeutic ranges that are essential to cease anaphylaxis at an early stage and stop development to a extra extreme response.”

The EPIPHAST II trial was designed to match single doses of AQST-109 to EpiPen® 0.3mg and epinephrine 0.3mg intramuscular (IM) injection, in addition to repeat doses of AQST-109 to repeat doses of epinephrine 0.3mg IM injection. Outcomes from the only dose administration confirmed AQST-109 achieved a considerably sooner Tmax (12 minutes), in comparison with each EpiPen® (22.5 minutes) and epinephrine 0.3mg IM injection (45 minutes). AQST-109 repeat dosing supplied considerably greater drug plasma concentrations, with a Tmax of 8 minutes after administration, and in depth absorption was noticed. The imply most focus (Cmax) of AQST-109 was 465 pg/mL after one dose and a couple of,958 pg/mL after two doses. As compared, the epi 0.3mg IM injection Cmax was 489 pg/mL after one dose and 911 pg/mL after two doses. The only dose of EpiPen resulted in a Cmax of 869 pg/mL.

After one dose of AQST-109, most imply results on systolic blood stress occurred inside 5 minutes of dosing in comparison with 8 minutes for EpiPen. Most imply results in coronary heart price occurred inside 8 minutes of administering AQST-109 in comparison with a median of 5 minutes inside administering EpiPen. Security outcomes for AQST-109 have been according to expectations, and no extreme or severe antagonistic occasions have been reported.

“We’re happy to see that AQST-109 in contrast favorably to each the EpiPen and the epi 0.3mg IM injection throughout a number of measures,” mentioned Daniel Barber, Chief Govt Officer of Aquestive. “This can be a significant step ahead for this program and brings us nearer to enhancing the lives of people who find themselves in search of alternate options to the present normal of look after allergic reactions. Literature means that over 40 million People are in danger for acute anaphylactic episodes. But, over half of those that have skilled anaphylaxis have by no means acquired an epinephrine auto-injector prescription. We imagine AQST-109 will present a significant addition to treating anaphylaxis and we look ahead to sharing the total dataset with the FDA, which would be the foundation for our end-of-Section 2 assembly scheduled for the fourth quarter of 2022.”

As we speak’s Convention Name and Webcast
Administration will host a convention name for buyers at 8:00 a.m. ET on Tuesday, September 27, 2022. With a purpose to take part, please register right here prematurely to acquire an area or toll-free cellphone quantity and your private pin.

The stay webcast can be out there on the Traders part of the Firm’s web site at  The webcast can be archived for 30 days.

About Anaphylaxis
Anaphylaxis is a severe systemic hypersensitivity response with speedy onset and probably deadly. As many as 49 million folks in the USA are at persistent danger for anaphylaxis. Lifetime prevalence is at the least 5%, or greater than 16 million folks in the USA. Direct prices of anaphylaxis have been estimated at $1.2 billion per yr, with direct expenditures of $294 million for epinephrine, and oblique prices of $609 million. The frequency of hospital admissions for anaphylaxis has elevated 500-700% within the final 10-15 years. 52% of sufferers, who beforehand skilled anaphylaxis, had by no means acquired an epinephrine autoinjector prescription, and 60% didn’t have an autoinjector at present out there. The most typical causes of anaphylaxis are meals (similar to peanuts), venom from insect stings, and drugs. Epinephrine injection is the present normal of remedy supposed to reverse the extreme manifestation of anaphylaxis, which can embody pores and skin rash, throat swelling, respiratory issues, gastrointestinal misery, and lack of consciousness.

About AQST-109
AQST-109 is a polymer matrix-based epinephrine prodrug administered as a sublingual movie that’s utilized underneath the tongue for the speedy supply of epinephrine. The product 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 AQST-109 is thinner and smaller than a median bank card, might be carried in a pocket, and is designed to resist climate excursions similar to publicity to rain and/or daylight.

About Aquestive Therapeutics
Aquestive Therapeutics, Inc. (NASDAQ: AQST) is a pharmaceutical firm advancing medicines to unravel sufferers’ issues with present requirements of care and supply transformative merchandise to enhance their lives. We’re creating orally administered merchandise to ship complicated molecules, offering novel alternate options to invasive and inconvenient normal of care therapies. Aquestive has 5 commercialized merchandise on the U.S. market, 4 licensed merchandise and one stand-alone proprietary product thus far, Sympazan® (clobazam) oral movie for the remedy of seizures related to Lennox-Gastaut syndrome. Our licensees market their merchandise within the U.S. and world wide. The Firm additionally collaborates with pharmaceutical corporations 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 pipeline targeted on treating ailments of the central nervous system, or CNS, and an earlier stage pipeline for the remedy of extreme allergic reactions, together with anaphylaxis. For extra info, go to Aquestive.com and observe us on LinkedIn.

Ahead Trying Assertion
Sure statements on this press launch embody “forward-looking statements” inside the that means of the Personal Securities Litigation Reform Act of 1995. Phrases similar to “imagine,” “anticipate,” “plan,” “count on,” “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 concerning the development and associated timing of AQST-109 by way of the regulatory and growth pipeline and scientific and enterprise methods, market alternatives, and different statements that aren’t historic details. These forward-looking statements are topic to the unsure influence of the COVID-19 international pandemic on our enterprise together with with respect to our scientific trials together with web site initiation, affected person enrollment and timing and adequacy of scientific trials; on regulatory submissions and regulatory opinions and approvals of our product candidates; pharmaceutical ingredient and different uncooked supplies provide chain, manufacture, and distribution; sale of and demand for our merchandise; our liquidity and availability of capital sources; buyer demand for our services and products; clients’ capacity to pay for items and providers; and ongoing availability of an applicable labor pressure and expert professionals. Given these uncertainties, the Firm is unable to supply assurance that operations might be maintained as deliberate previous to the COVID-19 pandemic.

These forward-looking statements are primarily based on our present expectations and beliefs and are topic to various 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 the Firm’s growth work, together with any delays or modifications to the timing, value and success of our product growth actions and scientific trials for AQST-109 and our different product candidates; danger of delays in FDA approval of AQST-109, Libervant™ (diazepam) Buccal Movie and our different drug candidates or failure to obtain FDA approval; capacity to handle the considerations recognized within the FDA’s Full Response Letter dated September 25, 2020 concerning the New Drug Utility for Libervant; danger of our capacity to show to the FDA “scientific superiority” inside the that means of the FDA rules of Libervant relative to FDA-approved diazepam rectal gel and nasal spray merchandise together with by establishing a serious contribution to affected person care inside the that means of FDA rules relative to the permitted merchandise in addition to dangers associated to different potential pathways or positions that are or might sooner or later be superior to the FDA to beat the seven yr orphan drug exclusivity granted by the FDA for the permitted nasal spray product of a competitor within the U.S. and there might be no assurance that we are going to achieve success; danger {that a} competitor obtains FDA orphan drug exclusivity for a product with the identical energetic moiety as any of our different drug merchandise for which we’re looking for FDA approval and that such earlier permitted competitor orphan drug blocks such different product candidates within the U.S. for seven years for a similar indication; danger in acquiring market entry for different causes; danger inherent in commercializing a brand new product (together with expertise dangers, monetary dangers, market dangers and implementation dangers and regulatory limitations); danger of growth of our gross sales and advertising and marketing capabilities; danger of enough capital and money sources, together with entry to out there debt and fairness financing and revenues from operations, to fulfill all of our short-term and long run liquidity and money necessities and different money wants, on the occasions and within the quantities wanted; dangers associated to the outsourcing of sure advertising and marketing and different operational and workers features to 3rd events; danger of the speed and diploma of market acceptance of our product and product candidates; the success of any competing merchandise, together with generics; danger of the scale and development of our product markets; dangers 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 the Firm’s merchandise; danger of sudden patent developments; the influence of present and future laws and regulatory provisions on product exclusivity; laws or regulatory actions affecting pharmaceutical product pricing, reimbursement or entry; claims and dangers which will come up concerning the protection or efficacy of the Firm’s merchandise and product candidates; danger of lack of important clients; dangers associated to authorized proceedings and related prices, together with patent infringement, investigative and antitrust litigation issues; modifications in authorities legal guidelines and rules; danger of product recollects and withdrawals; uncertainties associated to basic financial, political, enterprise, business, regulatory and market situations and different uncommon objects; and different uncertainties affecting the Firm described within the “Danger Components” part and in different sections included in our Annual Report on Type 10 Okay, in our Quarterly Stories on Type 10-Q, and in our Present Stories on Type 8-Okay filed with the Securities Change 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 us or any individual performing on our 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 because of new info, future occasions or in any other case, besides as could also be required by relevant regulation.

PharmFilm®, Sympazan® and the Aquestive brand are registered emblems of Aquestive Therapeutics, Inc. All different registered emblems referenced herein are the property of their respective homeowners.

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