The Scottish Medicines Consortium (SMC) has approved Buccolam (midazolam, oromucosal solution) from ViroPharma for emergency treatment of prolonged, acute epileptic seizures in children (aged over three months) and teenagers.
The decision will give youngsters in Scotland an alternative to the standard emergency grand mal treatment, rectally administered diazepam.
Buccolam will be marketed in Scotland by ViroPharma Ltd, a subsidiary of US company ViroPharma Inc.
The SMC considered that Buccolam was at least as effective clinically as rectal diazepam and was more cost-effective.
Buccolam, which has anti-convulsant, sedative and muscle-relaxant effects, can be administered by parents and carers of children with epilepsy.
The medication is administered from a prefilled oral syringe to the space between the cheek and gums, to be absorbed through the lining of the mouth.
While various unlicensed forms of midazolam have been used with children in the UK, Buccolam is the first to have received a Paediatric Use Marketing Authorisation licence (in September 2011).
The licensing of Buccolam follows the advice of MHRA in recent years that “specific children’s-only medicines” should be made available as an alternative to giving children “cut-down doses” of adult medicines.
“The SMC’s approval of Buccolam as an emergency medication is welcome news for hundreds of families and clinicians in Scotland,” commented Lesslie A. Young, Chief Executive of Epilepsy Scotland. “We are delighted that this licensed drug is now available to treat infants to teenagers with severe and prolonged epileptic seizures.”
Thierry Darcis, ViroPharma’s General Manager for Europe, commented: “We are committed to delivering solutions that address critical gaps in care for patients living with few, if any, clinical treatment options.”
Nearly a million children and adolescents in the EU suffer from active epilepsy, which causes life-threatening seizures.