ViroPharma’s Buccolam has been specifically licensed for infants, children and adolescents to treat severe convulsions and epileptic seizures in Europe.
It is the first children’s medicine to be granted the Paediatric Use Marketing Authorisation (PUMA), delivering an age-specific dose in the right form for the child.
Dr June Raine, Director of Vigilance and Risk Management of Medicines, MHRA, said: “They are not simply ‘small adults’ and they respond differently to medication”.
The midazolam and oromucosal solution comes in a pre-filled syringe indicated for patients aged three months to 18 years of age.
The dose is administered via the cavity between the cheek and gum, a less invasive method than its current treatment option, which is rectally-administered diazepam.
The marketing authorisation is based on data gathered from four clinical trials testing Buccolam against diazepam, where Buccolam proved to be either comparable to, or better than the existing treatment.
“Children should have access to medicines that have been especially designed for them,” added Dr Raine.
The medicine previously received a positive opinion in June from the Committee for the Medicinal Products for Human Use (CHMP) and will now be available across the EU as well as Norway, Iceland and Liechtenstein.
Thierry Darcis, Vice President and General Manager of ViroPharma Europe, said: “We look forward to working closely with physicians across Europe as we launch Buccolam into the European markets”.