Safety and efficacy of diazepam autoinjector for the management of epilepsy

Abstract

Benzodiazepines represent the first choice treatment of acute repetitive seizures, and diazepam is one of the main drugs administered to epileptic patients in the prehospital setting. Currently, Diazepam rectal gel is the only approved therapy for the outpatient management of seizures, but there is a growing need for alternative medications for terminating seizures that may be not only safe and effective but also socially acceptable. According to this, the autoinjector device appears to be a promising tool for the treatment of acute repetitive seizures. Recent studies comparing diazepam autoinjector (AI) with placebo suggest that diazepam AI could be a safe and effective option to treat acute repetitive seizures when administered by trained caregivers in outpatient settings. However, additional studies comparing diazepam AI with a standard treatment are necessary to define possible added benefits of this technique.

Keywords:

• acute repetitive seizures
• benzodiazepines
• buccal midazolam
• diazepam auto-injector
• epilepsy
• intranasal midazolam
• rectal diazepam

Financial & competing interests disclosure

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

No writing assistance was utilized in the production of this manuscript.

Key issues

• In developed countries, the annual incidence of epilepsy is nearly 50 per 100,000 population and prevalence is around 700 per 100,000.

• About 20–30% of patients with newly diagnosed epilepsy are drug-resistant, with frequent debilitating seizures.

• Acute repetitive seizures may progress to SE with severe consequences, such as neurological impairment, increased morbidity and mortality.

• Current worldwide guidelines for seizures treatment, in particular, for the so-called early SE, recommend the use of benzodiazepines.

• There are different ways of administration of benzodiazepines in the prehospital setting: the most used is the rectal one. Alternative routes of administration are the buccal, the intranasal and the intramuscular one through an autoinjection device.

• Preliminary studies with diazepam auto-injector seem to suggest that this way of administration may be an effective and safe option for the management of seizures by nonprofessional caregivers and may reveal to be a more convenient and socially acceptable way of administration if compared with a rectal device.