- The study confirms the dosing algorithm developed for Libervant (diazepam) buccal film, a potentially first in class oral treatment for breakthrough or cluster seizures
- Libervant adult rolling New Drug Application (NDA) submission expected to be completed in the fourth quarter of 2019
WARREN, N.J., Aug. 06, 2019 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (AQST), a specialty pharmaceutical company focused on developing and commercializing differentiated products that meet patients’ unmet needs and solve therapeutic problems, today announced topline results from the recently completed single dose crossover study for Libervant™ (diazepam) Buccal Film, which is in development for the management of select patients with refractory epilepsy who require treatment to control episodes of increased seizure activity, or “seizure clusters.”
The single dose crossover study was designed to compare diazepam maximal plasma [or blood] concentrations from a dose of Libervant and its reference drug, a diazepam rectal gel, in the same patient population, and provide the final set of data to confirm the proposed dosing regimen for Libervant. Subjects were dosed in accordance with body weight into one of four weight categories. A total of 28 of the 31 patients enrolled were included in the primary analysis. Patients eligible for analysis were stable on concurrent anti-epileptic medications (no changes to concomitant medications allowed from 30 days prior to dosing and throughout the study). Subjects were dosed within 30 minutes of the start of a moderate fat meal and monitored for 10 days after each dose.
Topline results show the study met its co-primary endpoints for diazepam maximal plasma concentration (Cmax), Area Under the Curve (AUC), and time to maximal concentration (Tmax). As quality reviews and statistical analyses continue, the preliminary findings include:
- Diazepam exposure following the buccal film showed comparable bioavailability to the rectal gel as assessed by maximal plasma concentration (Cmax). Across the four weight classes, buccal film demonstrated more consistent Cmax values than was observed in this study for rectal gel.
- The bioavailability of diazepam administered as the buccal film, assessed by AUC, was comparable or higher than rectal gel for the study population overall and also within each of the four weight categories. This finding suggests that any effect of enzyme induction from concomitant medications acted with equal effect on the film and the gel.
- The Tmax of diazepam film administration in patients under fed conditions was comparable to the results from previous studies of healthy volunteers who were under fasting conditions.
Three patients failed to achieve therapeutic concentrations of diazepam when using rectal gel. There were no such failures following buccal film administration.
“We believe Libervant can be a major contribution to patient care for refractory epilepsy patients seeking a better alternative to existing therapies for the management of breakthrough seizures,” said Keith J. Kendall, Chief Executive Officer of Aquestive Therapeutics. “We believe the results of this study confirm our dosing algorithm and satisfy the final clinical requirement requested by the FDA. We expect to successfully complete the NDA filing this year and bring Libervant to patients in 2020, following approval.”
About Aquestive Therapeutics
Aquestive Therapeutics is a specialty pharmaceutical company that applies innovative technology to solve therapeutic problems and improve medicines for patients. Aquestive is advancing a late-stage proprietary product pipeline to treat CNS conditions and 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.
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believe,” "anticipate," "plan," "expect," "estimate," "intend," "may," "will," or the negative of those terms, and similar expressions, are intended to identify forward-looking statements. These forward-looking statements may include, but are not limited to, statements about our growth and future financial and operating results and financial position, ability to advance Libervant to the market, regulatory approvals and pathways, clinical trial timing and plans, short-term and long-term liquidity and cash requirements, cash funding and cash burn, business strategies, market opportunities, and other statements that are not historical facts.
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