Aquestive Therapeutics Delivers Organization Update

Resubmitted revised dosing routine for Libervant to Fda in December 2020, as fully commited

Many clinical trials demonstrate that AQST-108 can regularly deliver epinephrine

WARREN, N.J., Jan. 07, 2021 (Globe NEWSWIRE) — Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical enterprise concentrated on building and commercializing differentiated products and solutions that deal with patients’ unmet needs and remedy therapeutic difficulties, right now furnished an update on latest developments in its enterprise.

“Given the progress on Libervant™ and AQST-108, 2021 will be an interesting and crucial calendar year in the ongoing advancement of Aquestive and for the execution of our company, medical and business tactic,” claimed Keith J. Kendall, President and Main Govt Officer of Aquestive. “As we look in advance to 2021, our concentration will be on the improvement of Libervant and epinephrine as a result of our regulatory and enhancement pipeline, as perfectly as expanding our commercial sales of Sympazan® and continuing to manufacture Suboxone® and other licensed merchandise from our film producing capabilities.”

Key Highlights:

Libervant. As formerly declared, at a Form A conference held on November 12, 2020, the U.S. Food and Drug Administration (Fda) verified that the challenges recognized in the Total Reaction Letter (CRL) relevant to the New Drug Application (NDA) for the Company’s drug applicant Libervant™ (diazepam) Buccal Movie for administration of seizure clusters could be addressed by making use of modeling and simulations primarily based on the data provided by Aquestive in its Food and drug administration conference package deal submitted in October 2020. Vital updates are:

The Organization resubmitted a revised weight-primarily based dosing program along with modeling and simulations in December 2020.

Primarily based on correspondence from the Fda, the Firm expects to get feed-back and direction from the Fda in late January.

The Enterprise expects to resubmit the NDA, based on even more Fda suggestions, throughout the very first 50 percent of 2021.

Epinephrine
. Making use of Aquestive’s PharmFilm® systems, AQST-108 is a “first of its kind” oral sublingual film formulation delivering systemic epinephrine that is in growth for the cure of anaphylaxis. Essential updates are:

Aquestive finished its next Period 1 pharmacokinetic (PK) trial in 24 balanced grownup subjects, which featured a 4-therapy crossover design comparing pharmacokinetics, basic safety and pharmacodynamics of epinephrine administered in a sublingual movie to that of epinephrine administered by means of both subcutaneous and intramuscular injections.

The information from many trials demonstrate that AQST-108 can constantly deliver epinephrine sublingually and all subjects experienced measurable plasma concentrations of epinephrine.

Centered on prime-line study effects, AQST-108 was usually perfectly-tolerated, with adverse occasions observed that are consistent with the acknowledged adverse occasions profile for epinephrine.

AQST-108 obtained a comparable time to maximal concentrations, or median Tmax, when when compared to both equally the subcutaneous and intramuscular injections of epinephrine.

The Organization strategies on commencing yet another PK trial in the initially quarter of 2021 as it proceeds to progress in the direction of a last solution formulation and dose.

“The topline knowledge from the second PK examine for AQST-108 offers further evidence that we have created a distinctive technological alternative that can produce epinephrine by means of oral administration,” mentioned Mr. Kendall. “The examine provides important perception into how our technology works. In 2021, we will keep on to advance our plan by conducting more human studies as properly as functioning closely with the Fda. We glance ahead to supplying more insight on our technological option at an R&D day to be scheduled in the 1st quarter of 2021. Regarding our drug applicant, Libervant, we search ahead to receiving responses from the Company and resubmitting our NDA as speedily as possible.”

About Aquestive Therapeutics
Aquestive Therapeutics is a pharmaceutical enterprise that applies revolutionary know-how to resolve therapeutic troubles and strengthen medications for sufferers. The Business has commercialized one particular internally-made proprietary product to date, Sympazan, has a commercial proprietary solution pipeline centered on the procedure of illnesses of the central nervous process, or CNS, and other unmet needs, and is creating orally administered intricate molecules to deliver alternate options to invasively administered typical of care therapies. The Company also collaborates with other pharmaceutical organizations to bring new molecules to marketplace working with proprietary, finest-in-class systems, like PharmFilm®, and has verified capabilities for drug progress and commercialization.

Forward-Seeking Statements
Particular statements in this press launch are “forward-hunting statements” within the meaning of the Non-public Securities Litigation Reform Act of 1995. Text these as “believe,” “anticipate,” “plan,” “expect,” “estimate,” “intend,” “may,” “will,” or the detrimental of all those phrases, and very similar expressions, are intended to detect ahead-hunting statements. These ahead-seeking statements consist of, but are not minimal to, statements pertaining to the progression of Libervant and AQST-108 by the regulatory and enhancement pipeline the emphasis on rising the Company’s commercial revenue of Sympazan® and continuing to manufacture Suboxone® and other licensed products means to address the concerns determined in the FDA’s Total Reaction Letter dated September 25, 2020 concerning the New Drug Software for Libervant and get Food and drug administration acceptance of Libervant for U.S. industry entry medical trial timing and programs for AQST-108 and small business techniques, sector options, and other statements that are not historic info. These ahead-hunting statements are matter to the uncertain impression of the COVID-19 worldwide pandemic on our business enterprise including with respect to our medical trials together with site initiation, client enrollment and timing and adequacy of clinical trials on regulatory submissions and regulatory assessments and approvals of our product or service candidates pharmaceutical component and other raw supplies provide chain, manufacture, and distribution sale of and demand for our solutions our liquidity and availability of cash sources consumer need for our merchandise and products and services customers’ ability to shell out for merchandise and companies and ongoing availability of an suitable labor pressure and experienced industry experts. Given these uncertainties, the Company is not able to present assurance that operations can be maintained as planned prior to the COVID-19 pandemic.

These forward-wanting statements are based mostly on our present-day anticipations and beliefs and are matter to a amount of pitfalls and uncertainties that could induce actual final results to differ materially from those people described in the forward-on the lookout statements. This sort of challenges and uncertainties incorporate, but are not restricted to, hazards associated with the Company’s growth operate, which include any delays or variations to the timing, cost and accomplishment of our merchandise advancement routines and scientific trials and ideas for AQST-108 and our other drug candidates possibility of delays in Food and drug administration acceptance of Libervant and AQST-108 and our other drug candidates or failure to receive acceptance risk of our ability to exhibit to the Food and drug administration “clinical superiority” inside the that means of the Fda rules of our drug applicant Libervant relative to Food and drug administration-permitted diazepam rectal gel and nasal spray merchandise like by setting up a big contribution to patient care inside the this means of Food and drug administration regulations relative to the accredited products as very well as challenges relevant to other potential pathways or positions which are or may perhaps in the upcoming be advanced to the Fda to triumph over the 7 year orphan drug exclusivity granted by the Fda for the authorized nasal spray item of a competitor in the U.S. and there can be no assurance that we will be successful hazard that a competitor obtains Fda orphan drug exclusivity for a products with the exact same energetic moiety as any of our other drug products and solutions for which we are seeking Fda approval and that these before accepted competitor orphan drug blocks these types of other product or service candidates in the U.S. for seven yrs for the exact same indication danger inherent in commercializing a new product or service (which includes engineering challenges, money threats, marketplace challenges and implementation hazards and regulatory constraints) threats and uncertainties regarding the royalty and other revenue stream of the KYNMOBI monetization, achievement of royalty targets all over the world or in any jurisdiction and certain other commercial targets demanded for contingent payments beneath the monetization transaction, and of sufficiency of web proceeds of the monetization transaction just after satisfaction of and compliance with 12.5% Senior Notes obligations, as applicable, and for funding the Company’s operations risk of improvement of our revenue and internet marketing capabilities risk of legal expenditures associated with and the outcome of our patent litigation tough third party at possibility generic sale of our proprietary goods risk of adequate capital and funds means, like access to accessible financial debt and equity financing and revenues from functions, to satisfy all of our shorter-expression and lengthier phrase cash necessities and other income requires, at the situations and in the amounts required threat of failure to fulfill all monetary and other credit card debt covenants and of any default our and our competitors’ orphan drug approval and ensuing drug exclusivity for our items or goods of our rivals shorter-term and extensive-time period liquidity and cash demands, income funding and funds burn off threat associated to federal government claims against Indivior for which we license, manufacture and market Suboxone® and which accounts for the substantial component of our present-day working revenues threat connected with Indivior’s cessation of generation of its approved generic buprenorphine naloxone film item, including the affect from loss of orders for the authorized generic product or service and risk of eroding market share for Suboxone and chance of sunsetting products pitfalls relevant to the outsourcing of particular marketing and other operational and team functions to third parties possibility of the level and degree of sector acceptance of our product or service and products candidates the achievement of any competing goods, like generics threat of the dimensions and expansion of our item marketplaces challenges of compliance with all Food and drug administration and other governmental and purchaser demands for our manufacturing amenities pitfalls connected with intellectual property legal rights and infringement promises relating to the Company’s merchandise risk of surprising patent developments the impression of existing and foreseeable future laws and regulatory provisions on merchandise exclusivity legislation or regulatory actions affecting pharmaceutical merchandise pricing, reimbursement or entry statements and risks that could occur regarding the safety or efficacy of the Company’s products and solution candidates chance of decline of significant consumers threats connected to lawful proceedings, together with patent infringement, investigative and antitrust litigation matters changes in govt legal guidelines and polices danger of products recalls and withdrawals uncertainties connected to general economic, political, small business, field, regulatory and current market problems and other unusual merchandise and other uncertainties affecting the Corporation explained in the “Risk Factors” section and in other sections involved in our Once-a-year Report on Type 10 K, in our Quarterly Stories on Type 10-Q, and in our Existing Experiences on Sort 8-K submitted with the Securities Exchange Fee (SEC). Given those uncertainties, you ought to not place undue reliance on these ahead-wanting statements, which discuss only as of the day designed. All subsequent ahead-seeking statements attributable to us or any particular person acting on our behalf are expressly qualified in their entirety by this cautionary assertion. The Business assumes no obligation to update ahead-hunting statements or outlook or advice immediately after the date of this press release whether or not as a result of new information, upcoming situations or usually, except as may possibly be necessary by relevant law.

PharmFilm®, Sympazan® and the Aquestive brand are registered logos of Aquestive Therapeutics, Inc. All other registered trademarks referenced herein are the home of their respective proprietors.

Trader inquiries:
Westwicke, an ICR Corporation
Stephanie Carrington
[email protected]
646-277-1282