Aquestive Therapeutics provides business update, 2023 objectives

Aquestive Therapeutics provided an update on recent business developments and outlined key 2023 objectives. "In 2023, we plan to focus our resources on the following key initiatives: advancing AQST-109 into a pivotal PK study, continuing to work with the FDA to potentially accelerate the market access for Libervant, exploring new capabilities for our manufacturing business,continuing to expand our base of strategic collaborations with other companies, and strengthening our balance sheet," remarked CEO Daniel Barber. "We are thankful for the collaborations that we have forged with a variety of global companies, including Indivior Inc., Zambon S.p.A., Otter Pharmaceuticals, Mitsubishi Tanabe Pharma America, Inc., Atnahs Pharma UK, Haisco Pharmaceutical Group Co., Ltd., and Hypera S.A. It is worth highlighting that the majority of these collaborations were entered into over the last 24 months. We look forward to securing possible additional collaborations in 2023 as we continue to prioritize our alliance strategies to bringing innovative and, in some cases, life-saving medications to patients." AQST-109: In late December 2022, Aquestive received the final minutes from the End-of-Phase 2 meeting with the United States Food and Drug Administration for AQST-109 for the treatment of severe allergic reactions including anaphylaxis, which provided clarity as to the FDA’s expectations regarding key program areas. Aquestive is conducting additional analysis regarding the bracketing of PK performance of approved epinephrine products and plans to finalize its protocol for the pivotal PK trial in the first half of 2023. Aquestive anticipates conducting the pivotal PK study in the second half of 2023, and continues to plan for a potential launch in 2025, if approved by the FDA. Libervant: The Company continues to actively pursue U.S. market access for Libervant Buccal Film. Libervant was tentatively approved by the FDA in August 2022, subject to an Orphan Drug Exclusivity block until January 2027 based on a competing product. The Company provided the FDA with additional clinical data in September 2022 and has been informed that the FDA is reviewing this data. Furthermore, in October 2022, the Company provided the FDA with a draft protocol for a head-to-head comparative PK study of Libervant versus the competing product. This was followed by a publication of a crossover food effect PK study of diazepam nasal spray in the peer-reviewed scientific journal Epilepsia in late November 2022. Commercial Collaborations and Manufacturing: The Company continues to anticipate strong order demand for the manufacture of Indivior’s Suboxone Sublingual Film in 2023. In addition, the Company is prepared to support the continued growth of Hypera’s Ondif Oral Film in Brazil, Zambon’s upcoming launch of riluzole oral film in Europe, and the ongoing marketing efforts of Assertio with Sympazan Oral Film. Furthermore, the Company is currently exploring possible out-licensing opportunities for Libervant in several markets, including the U.S., China, and South America. The Company plans on exploring possible out-licensing opportunities for AQST-109 outside of the United States in 2023. In 2022, the Company completed work to expand its manufacturing capabilities to include serialization and secondary packaging. This expansion allows the Company to support its existing and possible future business collaborations more broadly. With over 90,000 square feet of GMP facilities in Indiana, the Company will continue to explore possible additional manufacturing capabilities in 2023.