WASHINGTON (dpa-AFX) - ViroPharma Inc. (VPHM) said the Committee for Medicinal Products for Human Use CHMP of the European Medicines Agency or EMA has adopted a positive opinion recommending approval of a Pediatric Use Marketing Authorization or PUMA for Buccolam, for treatment of prolonged, acute, convulsive seizures in infants, toddlers, children and adolescents, from 3 months to less than 18 years.
If approved by the European Commission, Buccolam would be the first product approved through the centralized PUMA procedure. Buccolam is oral midazolam provided in a pre-measured, age-specific dose formulation for convenient buccal delivery.
The company noted that Buccal midazolam has been shown in 4 clinical studies to be either comparable or superior in both its effectiveness and speed of onset of action to the current standard treatment, rectally-administered diazepam, for terminating pediatric convulsive epileptic seizures.
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