BUCCOLAM (midazolam) - Epileptic seizures in adults

The clinical benefit of BUCCOLAM (midazolam) 10 mg oromucosal solution is substantial in the treatment of prolonged, acute, convulsive seizures in adults.

Considering:

• the efficacy of midazolam oromucosal solution having been established in the treatment of prolonged, acute, convulsive seizures in the paediatric population, primarily as an alternative to rectal diazepam,
• the efficacy in adults based on extrapolation of the efficacy results observed in the paediatric population and pharmacokinetic data,
• the lack of comparative efficacy data in adults versus the other benzodiazepines available,
• the oromucosal administration method, which is more appropriate for outpatient treatment than the routes of administration of the other benzodiazepines available, but without any formal evidence of an improvement in care conditions,
• the known safety profile of midazolam, with the profile in adults having been considered to be identical to that observed in children,

the Committee deems that BUCCOLAM (midazolam) 10 mg oromucosal solution provides no clinical added value (CAV V) in the current care pathway, which includes relevant comparators in the treatment of prolonged, acute, convulsive seizures in adults.