Diazepam buccal film is being developed as an oral rescue therapy for patients with breakthrough seizures or seizure clusters.
In the United States, 1.2 million people suffer from uncontrolled breakthrough seizures. Two hundred thousand additional people receive similar diagnoses each year.1 The current standard of care for breakthrough seizures (or increased bouts of seizure activity) is rectally administered diazepam. However, this treatment’s lengthy, 14-step administration procedure may pose a barrier to use for many patients.2
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.
Our Chief Operating Officer, Dan Barber, discusses the hope to provide both patients and
providers with a new treatment option for breakthrough seizures.
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.
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.