WARREN, N.J., Jan. 07, 2021 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic problems, today provided an update on recent developments in its business.

“Given the progress on Libervant™ and AQST-108, 2021 will be an exciting and important year in the continued growth of Aquestive and for the execution of our corporate, clinical and commercial strategy,” said Keith J. Kendall, President and Chief Executive Officer of Aquestive. “As we look ahead to 2021, our focus will be on the advancement of Libervant and epinephrine through our regulatory and development pipeline, as well as growing our commercial sales of Sympazan® and continuing to manufacture Suboxone® and other licensed products from our film manufacturing capabilities.”

Key Highlights:

Libervant. As previously announced, at a Type A meeting held on November 12, 2020, the U.S. Food and Drug Administration (FDA) confirmed that the issues identified in the Complete Response Letter (CRL) related to the New Drug Application (NDA) for the Company’s drug candidate Libervant™ (diazepam) Buccal Film for management of seizure clusters may be addressed by utilizing modeling and simulations based upon the information provided by Aquestive in its FDA meeting package submitted in October 2020. Key updates are:

• The Company resubmitted a revised weight-based dosing regimen along with modeling and simulations in December 2020.
• Based on correspondence from the FDA, the Company expects to receive feedback and guidance from the FDA in late January.
• The Company expects to resubmit the NDA, based on further FDA feedback, during the first half of 2021.

Epinephrine. Utilizing Aquestive’s PharmFilm® technologies, AQST-108 is a “first of its kind” oral sublingual film formulation delivering systemic epinephrine that is in development for the treatment of anaphylaxis. Key updates are:

• Aquestive completed its second Phase 1 pharmacokinetic (PK) trial in 24 healthy adult subjects, which featured a 4-treatment crossover design comparing pharmacokinetics, safety and pharmacodynamics of epinephrine administered in a sublingual film to that of epinephrine administered via both subcutaneous and intramuscular injections.
• The data from multiple trials demonstrate that AQST-108 can consistently deliver epinephrine sublingually and all subjects had measurable plasma concentrations of epinephrine.
• Based on top-line study results, AQST-108 was generally well-tolerated, with adverse events observed that are consistent with the known adverse events profile for epinephrine.
• AQST-108 achieved a similar time to maximal concentrations, or median Tmax, when compared to both the subcutaneous and intramuscular injections of epinephrine.
• The Company plans on commencing another PK trial in the first quarter of 2021 as it continues to progress towards a final product formulation and dose.

“The topline data from the second PK study for AQST-108 provides further evidence that we have developed a unique technological solution that can deliver epinephrine through oral administration,” said Mr. Kendall. “The study provides valuable insight into how our technology works. In 2021, we will continue to advance our program by conducting additional human studies as well as working closely with the FDA. We look forward to providing more insight on our technological solution at an R&D day to be scheduled in the first quarter of 2021. Regarding our drug candidate, Libervant, we look forward to receiving feedback from the Agency and resubmitting our NDA as quickly as possible.”

About Aquestive Therapeutics

Aquestive Therapeutics is a pharmaceutical company that applies innovative technology to solve therapeutic problems and improve medicines for patients. The Company has commercialized one internally-developed proprietary product to date, Sympazan, has a commercial proprietary product pipeline focused on the treatment of diseases of the central nervous system, or CNS, and other unmet needs, and is developing orally administered complex molecules to provide alternatives to invasively administered standard of care therapies. The Company also collaborates with other pharmaceutical companies to bring new molecules to market using proprietary, best-in-class technologies, like PharmFilm®, and has proven capabilities for drug development and commercialization.