Epilepsy treatment now available as licensed medicine

by Sandhiya Sodha on the 8 September 2017

Epistatus (midazolam), previously classified as an unlicensed special, has been granted a UK marketing authorisation and is now available to prescribe as a licensed medicine for children with epilepsy.

Midazolam is a schedule 3 controlled drug and prescriptions for it should comply with CD requirements. | VERITON PHARMA

Epistatus, an oromucosal solution containing 10mg/ml midazolam, is licensed for the treatment of prolonged, acute, convulsive seizures in children and adolescents aged 10 to less than 18 years, who have been diagnosed with epilepsy.

Further information

View Epistatus drug record Summary of Product Characteristics Manufacturer: Veriton Pharma

Epistatus has been formulated for buccal administration and is presented in a ‘ready-to-use’, pre-filled, single-dose oral syringe to facilitate administration of the correct dose.

NICE recommends buccal midazolam as first-line treatment in children, young people and adults with prolonged or repeated convulsive seizures.

'The importance of having an alternate licensed preparation for use in the treatment of prolonged, acute convulsive seizures, especially in a different mode of delivery, is an asset to both clinicians and patients', said Dr Rohit Shankar, consultant in adult developmental neuropsychiatry at the Cornwall Partnership NHS Foundation Trust.

The alternative buccal midazolam preparation Buccolam is licensed for use in children from 3 months to less than 18 years.