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ViroPharma Announces Positive CHMP Opinion for Buccolam® (Midazolam, Oromucosal Solution) in the European Union
Date:6/24/2011

ided in a unique individual dose formulation for buccal delivery.  It is provided as a convenient, portable, ready to use, pre-filled, age-specific dose to treat prolonged acute convulsive epileptic seizures in children, for use in the community.  Buccolam is fixed-dose, banded by age, to provide approximately 0.25 to 0.5 mg/kg, based upon the pivotal clinical studies and recommended by the British National Formulary for Children (BNFC).  The company is seeking approval through a PUMA which was submitted to the EMA in 2010. ViroPharma is pursuing marketing authorization in the EU for Buccolam for treatment of prolonged, acute, convulsive seizures in infants, toddlers, children and adolescents, from three months to less than 18 years.  

The CHMP is also recommending that Buccolam should only be used in by patients/carers where the patient has been diagnosed to have epilepsy.  For infants between 3-6 months of age, treatment should be in a hospital setting where monitoring is possible and resuscitation equipment is available.

About Non-Epileptic and Epileptic Seizures

Seizures occur because of sudden and abnormal electrical activity in the brain. There are many causes of seizures affecting pediatric patients other than epilepsy, including medicines, head injuries, certain diseases, and high fevers (called 'febrile seizures'). Febrile seizures are the most common type of seizure in children; approximately one in every 25 children will have at least one febrile seizure, and more than one-third of these children will have additional febrile seizures before they outgrow the tendency to have them. Epilepsy is among the most common childhood neurological disorders in developed countries, affecting nearly one percent of the population.  There are over four million people affected by epilepsy in Europe; and nearly one million European children and adole
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SOURCE ViroPharma Incorporated
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