Aquestive Therapeutics to Present Positive Data from Pharmacokinetic Studies for AQST-109 (epinephrine sublingual film) at American Academy of Allergy, Asthma, and Immunology (ACAAI) Annual Scientific Meeting
November 09, 2022 at 16:33 PM EST
WARREN, N.J., Nov. 09, 2022 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company advancing current standards of care to solve patients’ problems through simplifying complex delivery methods, will present three abstracts recapping positive data from its completed pharmacokinetic studies of AQST-109 (epinephrine sublingual film) at the American College of Allergy Asthma and Immunology (ACAAI) Annual Scientific Meeting, which will be held from November 10-14, in Louisville, Kentucky.
“Not only are we excited to share the positive results from our two completed AQST-109 pharmacokinetic studies, but we are also honored to have results selected for presentation as a Distinguished Industry Oral Abstract, with the opportunity to highlight the formulation and dosage from the podium,” said Ken Truitt, M.D., Aquestive’s Chief Medical Officer. “We look forward to connecting with leaders in the allergy community and providing insight on how our research has the potential to provide an important advance in the treatment of acute allergic reactions.”
Abstract Title: Pharmacokinetics Study of Epinephrine Sublingual Film: Results from The Formulation and Dosage Selection
Abstract Title: Minimal Impact of Food, Drink, Or Temperature on The Pharmacokinetics of a Sublingual Film Using a Novel Prodrug of Epinephrine (DESF)
Abstract Title: Results of a Repeat Dose Study on The Pharmacokinetics of a Sublingual Film using a Novel Prodrug of Epinephrine (DESF)
About Aquestive Therapeutics
Forward Looking Statement
These forward-looking statements are based on our current expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Such risks and uncertainties include, but are not limited to, risks associated with the Company’s development work, including any delays or changes to the timing, cost and success of our product development activities and clinical trials for AQST-109 and our other product candidates; risk of delays by the United States Food and Drug Administration (FDA) in approving Libervant® (diazepam) Buccal Film for U.S. market; risk of our ability to demonstrate to the FDA “clinical superiority” of Libervant within the meaning of the FDA regulations relative to the FDA-approved diazepam nasal spray product of an unrelated company competitor in the U.S., including by establishing a major contribution to patient care within the meaning of FDA regulations relative to the approved product, as well as risks related to other potential pathways or positions which are or may in the future be advanced to the FDA to overcome the seven year orphan drug exclusivity granted by the FDA for the approved nasal spray product, and there can be no assurance that we will be successful; risk of delays in FDA approval of AQST-109 and our other drug candidates, or failure to receive FDA approval at all; risk that a competitor obtains FDA orphan drug exclusivity for a product with the same active moiety as any of our other drug products for which we are seeking FDA approval and that such earlier approved competitor orphan drug blocks such other product candidates in the U.S. for seven years for the same indication; risk in obtaining market access for other reasons; risk inherent in commercializing a new product (including technology risks, financial risks, market risks and implementation risks and regulatory limitations); risk of development of our sales and marketing capabilities; risk of sufficient capital and cash resources, including access to available debt and equity financing and revenues from operations, to satisfy all of our short-term and longer term liquidity and cash requirements and other cash needs, at the times and in the amounts needed; risks related to the outsourcing of certain marketing and other operational and staff functions to third parties; risk of the rate and degree of market acceptance of our product and product candidates; the success of any competing products, including generics; risk of the size and growth of our product markets; risks of compliance with all FDA and other governmental and customer requirements for our manufacturing facilities; risks associated with intellectual property rights and infringement claims relating to the Company’s products; risk of unexpected patent developments; the impact of existing and future legislation and regulatory provisions on product exclusivity; legislation or regulatory actions affecting pharmaceutical product pricing, reimbursement or access; claims and risks that may arise regarding the safety or efficacy of the Company's products and product candidates; risk of loss of significant customers; risks related to legal proceedings and associated costs, including patent infringement, securities, business torts, investigative and antitrust litigation matters; changes in government laws and regulations; risk of product recalls and withdrawals; uncertainties related to general economic, political, business, industry, regulatory and market conditions and other unusual items; and other uncertainties affecting the Company described in the “Risk Factors” section and in other sections included in our Annual Report on Form 10 K, in our Quarterly Reports on Form 10-Q, and in our Current Reports on Form 8-K filed with the Securities Exchange Commission. Given those uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date made. All subsequent forward-looking statements attributable to us or any person acting on our behalf are expressly qualified in their entirety by this cautionary statement. The Company assumes no obligation to update forward-looking statements or outlook or guidance after the date of this press release whether as a result of new information, future events or otherwise, except as may be required by applicable law.
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