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news.ViroPharma has received Centralized Pediatric Use Marketing Authorization (PUMA) from the European Commission (EC) for Buccolam (midazolam, oromucosal solution).
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Buccolam is indicated for the treatment of prolonged, acute, convulsive seizures in infants, toddlers, children and adolescents, from 3 months to less than 18 years of age.
Buccal has been demonstrated in four clinical trials to be either comparable or superior in both effectiveness and speed of onset of action to the current standard treatment, rectally-administered diazepam, to terminate pediatric convulsive seizures.
Buccolam is oromucosal midazolam provided in a pre-filled, age-specific dose formulation for convenient buccal delivery.
Buccolam is approved throughout all the Member States of the European Union (EU) and in the European Economic Area (EEA), including Norway, Iceland and Liechtenstein.
Following the approval of Buccolam, ViroPharma will pay £10m to the former owners of Auralis.