Aquestive Therapeutics Announces Late-Breaking Findings of its Investigational Diazepam Buccal Film (DBF) Formulation in Adults with Epilepsy
WARREN, N.J., /PRNewswire/ -- Aquestive Therapeutics Inc. (NASDAQ: AQST), a specialty pharmaceutical company, today announced findings from two clinical studies, including the Adult Epilepsy Monitoring Unit (EMU) study, showing that its investigational diazepam buccal film (DBF) was successfully used and had similar bioavailability whether administered between seizures (interictal) or during or shortly after seizures (ictal/peri-ictal) in adults with poorly controlled tonic-clonic seizures or focal seizures with impaired awareness. The findings are detailed in two presentations at the 72nd annual meeting of the American Epilepsy Society.
Investigational diazepam buccal film (DBF), tentatively named Libervant™, is a novel formulation of diazepam as a small, thin film strip for placement inside the cheek. Libervant leverages Aquestive's proprietary PharmFilm® technology, and is in development for the management of selected patients with refractory epilepsy who require intermittent use of diazepam to control episodes of increased seizure activity.
"Currently, the only formulations of diazepam approved by the U.S. Food and Drug Administration (FDA) for acute treatment of seizures are injected or rectally administered, which can be cumbersome and uncomfortable for patients who suffer from repetitive seizures," said Keith J. Kendall, Chief Executive Officer of Aquestive Therapeutics. "These findings, showing consistent usability and bioavailability, demonstrate Libervant's potential to address patient needs for an orally administered treatment alternative that is efficacious, easy to use and portable anywhere. We are excited to add this to our growing epilepsy franchise."
Findings from the diazepam buccal film (DBF) EMU study
The analysis demonstrating similar bioavailability during interictal and ictal/peri-ictal administration was based on pharmacokinetic data from 21 participants with valid pharmacokinetic data who received both Treatment A and Treatment B: specifically, diazepam maximal plasma concentration (Cmax), time to maximal concentration (Tmax), and partial area under the diazepam plasma concentration curve (partial AUC) at 2 or 4 hours following DBF administration. The ratio of geometric means for partial AUC at 2 hours comparing Treatment B (ictal/peri-ictal conditions) to Treatment A (interictal conditions) was 94% with a 90% confidence interval of 74% - 119% while the ratio of geometric means for Cmax was 93% with a 90% confidence interval of 75% - 113%. Mean Cmax levels for a dose of 12.5 mg DBF were 199 ng/mL and 184 ng/mL for Treatments A and B respectively. Median Tmax values were less than one hour for both conditions.
The most common adverse event possibly related to DBF was somnolence (sleepiness or drowsiness) reported in two (5.7%) of the 35 participants. There were no serious adverse events related to DBF, and no participant withdrew because of an adverse event.
The study also examined DBF's usability, based on correct administration of the film. This data is important in showing that an oral alternative can be accurately administered to patients. The study found that in all cases DBF was successfully placed and generally used without difficulty in both interictal and ictal/periictal states.
Abstracts with details of the study and results are available online at www.aesnet.org.
About Aquestive Therapeutics
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; the risks of delays in FDA approval of our drug candidates or failure to receive approval; the risks inherent in commercializing a new product (including technology risks, financial risks, market risks and implementation risks and regulatory limitations); development of our sales and marketing capabilities; the rate and degree of market acceptance of our product candidates; the success of any competing products; the size and growth of our product markets; the effectiveness and safety of our product candidates; risks associated with intellectual property rights and infringement; unexpected patent developments; and other risks and uncertainties affecting the Company including those described in the "Risk Factors" section included in our Registration Statement on Form S-1 declared effective by the SEC on July 24, 2018. As with any pharmaceutical product candidate under development, there are significant risks with respect to the development, regulatory approval and commercialization of new products. Given these 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. We assume no obligation to update our forward-looking statements after the date of this press release whether as a result of new information, future events or otherwise, except as may be required under applicable law.
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Company Codes: NASDAQ-NMS:AQST