Aquestive Therapeutics Announces Completion of Diazepam Buccal Film Adult Epilepsy Monitoring Unit (EMU) Clinical Study with Positive Topline Results

WARREN, N.J., Oct. 25, 2018 /PRNewswire/ -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a specialty pharmaceutical company, today announced the completion of a pharmacokinetic epilepsy monitoring unit (EMU) study demonstrating that its investigational diazepam buccal film (DBF), tentatively named Libervant^TM, provides comparable bioavailability whether administered between seizures (interictal) or during and shortly after seizures (ictal/peri-ictal) in adult patients with poorly controlled tonic-clonic seizures or focal seizures with impaired awareness. DBF, a novel formulation of diazepam as a small, thin film strip placed inside the cheek, is under development for the management of selected patients with refractory epilepsy who require intermittent use of diazepam to control episodes of increased seizure activity.

"Often it can be very difficult to administer treatment during periods of increased seizure activity. Currently, the only non-injected formulation of diazepam approved for the acute treatment of seizures is a rectally-applied gel," said Keith J. Kendall, Chief Executive Officer of Aquestive Therapeutics. "These pharmacokinetic findings, taken together with other DBF studies, will help advance the development of Libervant as an alternative to currently approved therapies. We are very excited to have achieved this critical milestone in the program."

In this single-dose cross-over study, investigators determined diazepam maximal plasma concentration (C_max), time to maximal concentration (T_max), and partial area under the diazepam plasma concentration curve (partial AUC) at 2 or 4 hours following administration of 12.5 mg of DBF to the patients while they underwent a clinical epilepsy monitoring unit evaluation. Results from this study have been accepted for late-breaking presentation at the upcoming 2018 meeting of the American Epilepsy Society.

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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SOURCE Aquestive Therapeutics