WARREN, N.J., Dec. 3, 2018 /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 separate presentations on DBF bioavailability and usability were based on a Phase 2, multicenter, open-label, crossover study in 35 adult men and women (ages 17-65 years) with poorly controlled tonic-clonic seizures or focal seizures with impaired awareness, who were being evaluated in an epilepsy monitoring unit or EMU. The participants received two treatments of DBF 12.5 mg separated by approximately three weeks: Treatment A, during interictal conditions, and Treatment B during ictal/peri-ictal conditions (during or within 5 minutes of a seizure). A total of 33 participants received Treatment A, and 33 participants received Treatment B.
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 Aquestive Therapeutics is a specialty pharmaceutical company committed to identifying, developing and commercializing differentiated products to address unmet medical needs. Aquestive Therapeutics has a late-stage proprietary product pipeline focused on the treatment of CNS diseases, and is working to advance orally-administered complex molecules that it believes can be alternatives to invasively-administered standard of care therapies. As the leader in developing and delivering drugs via its PharmFilm® technology, Aquestive Therapeutics also collaborates with pharmaceutical partners to bring new molecules to market in differentiated and highly-marketable dosage forms.
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