Home Pet & Animal Aquestive Receives Optimistic FDA Response to Epinephrine Sublingual Movie Section 2 Trial

Aquestive Receives Optimistic FDA Response to Epinephrine Sublingual Movie Section 2 Trial

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  • FDA’s Finish-of-Section 2 written response offers optimistic suggestions associated to Chemistry, Manufacturing, and Controls (CMC) to assist future NDA submitting
  • Helps strategy to characterizing Aquestive’s proprietary novel prodrug type of epinephrine API
  • Confirms Company alignment on deliberate stability packages for each API and Drug Product
  • FDA Finish-of-Section 2 assembly for scientific suggestions scheduled for later this quarter

WARREN, N.J., Oct. 11, 2022 (GLOBE NEWSWIRE) — Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical firm advancing present requirements of care to unravel sufferers’ issues by way of simplifying complicated supply strategies, immediately introduced optimistic written suggestions from the U.S. Meals and Drug Administration (FDA) for its preliminary Finish-of-Section 2 (EoP2) assembly request to debate Chemistry, Manufacturing, and Controls (CMC) for its AQST-109 epinephrine sublingual movie for the remedy of extreme allergic response together with anaphylaxis.

On August 2, 2022, Aquestive requested an EoP2 assembly to acquire steering and/or concurrence on particular questions regarding each drug substance and drug product characterization, management, and stability for its drug candidate AQST-109 epinephrine sublingual movie. In lieu of a gathering, the FDA supplied a proper written response to the Firm’s questions.

“We’re excited by the FDA’s written response confirming our strategy and supporting the characterization of our novel drug platform – an element that can accompany our NDA submitting for this product,” mentioned Daniel Barber, Chief Government Officer of Aquestive. “The optimistic Company response reinforces our improvement plans and strategy as we proceed to progress the AQST-109 program, together with in vital areas akin to assigning shelf life. We’re wanting ahead to our subsequent scheduled interplay with the FDA later this quarter the place we are going to focus on the outcomes of our EPIPHAST research and our scientific improvement plan.”

Stability and shelf life are well-documented matters for acute rescue merchandise containing epinephrine. Epinephrine is understood to degrade shortly and, because the EpiPen® label presently signifies, “[e]pinephrine answer deteriorates quickly on publicity to air or mild.” AQST-109 has been designed to attenuate publicity to air and light-weight till opened to be used. The FDA’s written response signifies that Aquestive’s strategy to characterizing these and different attributes of AQST-109 “seem cheap” within the context of a possible future submitting.

Aquestive has additionally requested an EoP2 assembly with the FDA to acquire steering and/or concurrence on particular questions regarding the scientific elements of a possible AQST-109 submitting. At this assembly, Aquestive anticipates receiving suggestions on its EPIPHAST research knowledge in addition to the proposed scientific improvement plan for AQST-109. This assembly has been granted by the FDA and is scheduled to happen previous to the tip of 2022.

About Anaphylaxis
Anaphylaxis is a severe systemic hypersensitivity response with fast onset and probably deadly. As many 49 million individuals in the USA are at persistent danger for acute anaphylactic episodes. Lifetime prevalence could also be increased than 5%. Persistent allergic sickness prices the US healthcare system greater than $18 billion yearly. The frequency of hospital admissions for anaphylaxis has elevated 500-700% within the final 10-15 years. 52% of sufferers, who had beforehand skilled anaphylaxis, had by no means obtained an epinephrine autoinjector prescription, and 60% didn’t have an autoinjector presently out there. The commonest causes of reactions that may embrace anaphylaxis are drugs, meals (akin to peanuts), and venom from insect stings. Epinephrine injection is the present normal of remedy meant to reverse the doubtless extreme manifestation of anaphylaxis, which can embrace pink 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 beneath the tongue for the fast 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, could be carried in a pocket, and is designed to face up to climate excursions akin to publicity to rain and/or daylight.

About Aquestive Therapeutics
Aquestive Therapeutics, Inc. (NASDAQ: AQST) is a pharmaceutical firm advancing present requirements of care to unravel sufferers’ issues by simplifying complicated supply strategies. Aquestive is creating orally administered merchandise to offer 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 all over the world. The Firm additionally collaborates with pharmaceutical corporations to convey new molecules to market utilizing proprietary, best-in-class applied sciences, like PharmFilm®, and has confirmed drug improvement and commercialization capabilities. Aquestive is advancing a late-stage proprietary product pipeline targeted on treating illnesses 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 embrace “forward-looking statements” throughout the which means of the Personal Securities Litigation Reform Act of 1995. Phrases akin to “imagine,” “anticipate,” “plan,” “count on,” “estimate,” “intend,” “might,” “will,” or the unfavorable of these phrases, and related expressions, are meant to determine forward-looking statements. These forward-looking statements embrace, however are usually not restricted to, statements relating to the development and associated timing of AQST-109 by way of the regulatory and improvement 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 affect 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 evaluations 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 assets; buyer demand for our services; clients’ capacity to pay for items and companies; and ongoing availability of an acceptable labor drive and expert professionals. Given these uncertainties, the Firm is unable to offer assurance that operations could 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 plenty of dangers and uncertainties that might trigger precise outcomes to vary materially from these described within the forward-looking statements. Such dangers and uncertainties embrace, however are usually not restricted to, dangers related to the Firm’s improvement work, together with any delays or modifications to the timing, value and success of our product improvement 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 deal with the considerations recognized within the FDA’s Full Response Letter dated September 25, 2020 relating to the New Drug Utility for Libervant; danger of our capacity to show to the FDA “scientific superiority” throughout the which means of the FDA laws of Libervant relative to FDA-approved diazepam rectal gel and nasal spray merchandise together with by establishing a serious contribution to affected person care throughout the which means of FDA laws relative to the accredited 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 accredited nasal spray product of a competitor within the U.S. and there could be no assurance that we’ll 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 in search of FDA approval and that such earlier accredited 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 improvement of our gross sales and advertising and marketing capabilities; danger of ample capital and money assets, 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 dimensions and progress 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 regarding the Firm’s merchandise; danger of sudden patent developments; the affect of current and future laws and regulatory provisions on product exclusivity; laws or regulatory actions affecting pharmaceutical product pricing, reimbursement or entry; claims and dangers that will come up relating to the security 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 laws; danger of product remembers and withdrawals; uncertainties associated to common financial, political, enterprise, trade, regulatory and market circumstances and different uncommon objects; and different uncertainties affecting the Firm described within the “Threat Components” part and in different sections included in our Annual Report on Kind 10-Ok, in our Quarterly Experiences on Kind 10-Q, and in our Present Experiences on Kind 8-Ok filed with the Securities and Trade 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 appearing 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 on account of new info, future occasions or in any other case, besides as could also be required by relevant regulation.

PharmFilm®, Sympazan® and the Aquestive emblem are registered logos of Aquestive Therapeutics, Inc. All different registered logos referenced herein are the property of their respective house owners.

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