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

EXTON, Pa., June 24, 2011 /PRNewswire/ -- ViroPharma Incorporated (Nasdaq: VPHM) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of a Pediatric Use Marketing Authorization (PUMA) for Buccolam® (midazolam, oromucosal solution), 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 (i.e. via the cavity between the cheek and gum line) delivery. Buccal midazolam has been shown in four 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.

"The potential approval of Buccolam would address a major challenge for physicians currently prescribing rectally-administered diazepam for acute seizures, namely that it can be difficult to use and may be socially unacceptable in the community," said Professor Ian Wong, Director of the Centre for Paediatric Pharmacy Research at the School of Pharmacy, University of London. "Midazolam is recommended for treating prolonged acute convulsive seizures according to published treatment guidelines in European countries, and the availability of Buccolam – an oromucosal formulation of midazolam – would be an important, convenient and welcomed alternative to treat seizures in pediatric and adolescent patients."

The CHMP is responsible for issuing the EMA's scientific evaluation and opinions on all Marketing Au
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SOURCE ViroPharma Incorporated
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