Rogawski MA, Heller AH, Epilepsy & Behavior, 2019;101 (Pt B):106537.

Purpose

New therapies to prevent seizure emergencies are an important area of research. Seizure clusters or periods of increased seizures often result in unnecessary trip to an emergency room, hospitalizations, time away from usual activities, injuries, and seizure emergencies. Status epilepticus (a seizure emergency) can lead to many complications and even death when not treated early and with the right medicines.

  • Rescue therapies are medicines that can be given outside of a medical setting by anyone trained in their use. They are intended to be given before a seizure becomes an emergency. The first rescue medicine approved by the Food and Drug Administration (FDA) was rectal diazepam gel (Diastat® AcuDial™). More recently, two rescue therapies that can be given into the nose have been approved: nasal diazepam or Valtoco, and nasal midazolam or Nayzilam.
  • This study presents information from tests done on a new form of diazepam, Diazepam Buccal Film, as a rescue therapy. This form of diazepam can be used buccally — this means it is placed inside the cheek or between the cheek and the gum.

Description of Study

This article reviewed studies on diazepam buccal film (DBF), which is not yet approved by the FDA. The brand name of this therapy is Libervant™. It provides diazepam in a thin film, smaller than the size of a postage stamp. It can easily be placed inside the cheek by the person with epilepsy or by another person. It sticks to the inside of the cheek and quickly dissolves. Some of the medicine may be swallowed and absorbed by the stomach. The data presented in this article reviews studies done in healthy volunteers and adults with epilepsy.

Summary of Study Findings

  • In healthy male volunteers without epilepsy, DBF doses of 5 to 15 mg were quickly absorbed.
  • The medicine reaches near peak levels in the bloodstream by 30-60 minutes. However, by 15 minutes, there may be enough to alter the seizure threshold. The levels are highest after a 15 mg dose is used.
  • A study of DBF in men and women with epilepsy showed that recent seizures did not change how DBF was absorbed.
  • DBF was easy to administer and could be accurately placed in all cases.
  • Sleepiness is a common side effect with all forms of diazepam. When this buccal film was used in a small study (35 people), only 2 people reported sleepiness. No other serious side effects were reported.
  • In another study, 31 adults were given DBF and then later were given rectal diazepam gel to compare how the two medicines worked. The buccal diazepam (DBF) was similar to rectal diazepam gel in how it worked in the body.
    • DBF was absorbed more consistently and had more stable drug levels in the body than rectal diazepam gel.
    • The time to the highest blood level of diazepam was longer with DBF (1 hour) than with rectal diazepam gel (31 minutes). It is unclear if this finding means that DBF may be slower to stop seizures than diazepam rectal gel. This will require further study.

What does this mean?

  1. These studies show that DBF, or a buccal film of diazepam, is absorbed easily and quickly. It is easy to use outside of a hospital setting by a person with epilepsy or a family member or caregiver. Once it is absorbed, it appears to work similarly in the body as rectal diazepam gel.
  2. Side effects are similar to other diazepam drugs, but sleepiness in this form was reported less often.
  3. If this medicine is approved by the FDA, it will broaden the ways that a rescue medicine can be given quickly to stop seizures.

Article published in Epilepsy & Behavior, December 2019.

we recommend
Authored By: 
Patty Osborne Shafer RN, MN
Authored Date: 
04/2020
Reviewed By: 
Elaine Wirrell MD
on: 
Monday, April 6, 2020