Diazepam Buccal Film (LibervantTM*) is being developed as an oral rescue therapy for patients with breakthrough seizures or seizure clusters.
In the United States, 1.2 million epilepsy patients suffer from uncontrolled breakthrough seizures.1 The target population for LibervantTM* is a subset of this population. Aquestive Therapeutics recognizes the need for an oral formulation of diazepam and is leveraging its proprietary PharmFilm® technology to develop this treatment.
Administering diazepam on a buccal film could be less invasive and may provide the advantage of consistent, reliable absorption.3-4
Our formulation team used PharmFilm® technology to develop a diazepam formulation that is absorbed directly through the buccal mucosa. The buccal mucosa’s wide, relatively immobile, and highly permeable surface area provided the stable and controlled microenvironment needed to optimize adhesion, absorption, and onset of action.
*Aquestive has received conditional acceptance of the use of this trade name, which is subject to final FDA review and acceptance.
Libervant (diazepam buccal film) is an investigational drug being evaluated for use in children and adults with refractory seizures, who remain on stable regimens of antiepileptic drugs, to control bouts of increased seizure activity. The product profile, data from our trials and related statements have not been approved by the FDA.
Our Chief Operating Officer, Dan Barber, discusses the hope to provide both patients and
providers with a new treatment option for breakthrough seizures.
1. Chen B, Choi H, Hirsch LJ, et al. Prevalence and risk factors of breakthrough seizures in adult patients with epilepsy Epilepsy Res. 2017 Jul;133:98-102.
2. Diastat® diazepam rectal gel administration and disposal instructions. Bridgewater, NJ: Valeant Pharmaceuticals North America. 2017. http://www.diastat.com/Portals/_default/Skins/diastat/pdfs/Diastat%20Administration%20Instructions%204_2019.pdf.
3. Holsti M, Dudley N, Schunk J, et al. Intranasal midazolam vs rectal diazepam for the home treatment of acute seizures in pediatric patients with epilepsy. Arch Pediatr Adolesc Med. 2010;164(8):747–753.
4. Data on file. Warren Township, NJ: Aquestive Therapeutics.