Midazolam Oromucosal Solution for the Management of Prolonged Convulsive Seizures in Adult Outpatients: Addressing Unmet Needs in Europe

Rapid treatment of prolonged convulsive seizures (PCS), preferably within the first few minutes after onset in most patients, is important to prevent progression to life-threatening status epilepticus (SE) and its associated complications. In community settings, benzodiazepine rescue medication for PCS is often administered by non-medical caregivers to achieve timely seizure control. Until recently, rectally administered diazepam was the only treatment approved by the European Medicines Agency (EMA) for PCS in adults. However, an oromucosal midazolam formulation, which has been approved by the EMA for PCS treatment in paediatric patients for over a decade, has now also received such approval for use in adults. The aim of this narrative review is to describe the role of midazolam oromucosal solution in the management of PCS in adults in community settings in Europe. The approval of midazolam oromucosal solution was supported by pharmacokinetic modelling studies, which extrapolated the efficacy of oromucosal midazolam to adults through exposure matching, alongside European clinical studies where oromucosal midazolam was used as an off-label treatment, thereby demonstrating its effectiveness for treating PCS and SE in adults and paediatric patients. With this approval, adult patients across Europe now have access to an alternative to rectal diazepam that is easy to administer, socially acceptable, and pharmacokinetically appropriate. The increased willingness of caregivers to administer rescue medication by the oromucosal compared with the rectal route should encourage its appropriate use, thus potentially improving outcomes for adults with PCS in Europe.