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 BuccolamÂ® (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 â€“ an oromucosal formulation of midazolam â€“ 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 Authorization Applications (MAAs) for medicines for human use. Their positive opinion forms the scientific basis for the European Commission to issue a binding decision for an MAA or a PUMA, a centralized marketing authorization which is valid throughout all the Member States of the European Union (EU) as well as in the European Economic Area (EEA), namely Norway, Iceland and Liechtenstein. The anticipated timeframe for the European Commission decision is by the fourth quarter of 2011. A summary of the CHMP opinion will be available here: http://tinyurl.com/2am4ubc. Please select "B" to access the Buccolam summary opinion.
"This positive CHMP opinion - the first for a product seeking centralized authorization through a PUMA - is a great step towards the European marketing authorization for Buccolam, a product that addresses significant unmet need for families and caregivers â€“ namely the quick and effective termination of prolonged, acute convulsive seizures in children and adolescents," commented Thierry Darcis, M.D., ViroPharma's vice president, general manager, Europe. "We will work closely with physicians across Europe on improving the seizure treatment paradigm, and bringing this much-needed emergency medication to market as soon as possible this year."
SOURCE ViroPharma Incorporated