Approval offers convenient alternative to treat prolonged acute convulsive seizures in children and adolescents
First ever product approved through European Commission's Centralized Paediatric Use Marketing Authorization (PUMA)
Therakind is delighted to announce that the European Commission has granted (September 2011) a centralised Paediatric 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 of age. Therakind was responsible for the regulatory development strategy for the product as well as the design, management and sponsoring of the clinical trial. This is the first product approval through the centralised PUMA procedure since its inception.
Buccal midazolam is already being used routinely in the treatment of acute seizures in children both in the UK and Europe but in an unlicensed form. It is now approved throughout all the Member States of the European Union (EU) as well as in the European Economic Area (EEA), namely Norway, Iceland and Liechtenstein.
Buccolam® is oromucosal midazolam provided in a pre-filled, age-specific dose formulation for convenient buccal (via the cavity between the cheek and gum) 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 paediatric convulsive seizures. Epilepsy is among the most common childhood neurological disorders in developed countries, affecting nearly 1% of the population. There are approximately six million people affected by epilepsy in Europe; nearly one million European children and adolescents have active epilepsy. If left untreated, seizures can lead to status epilepticus (SE) and patients may require hospitalisation and intensive care.
Therakind received a milestone payment on the granting of marketing approval for the product, and will receive royalties on product sales. In 2010 Therakind sold its controlling interest in Buccolam® to Viropharma Inc (subsequently acquired by Shire), who are responsible for product marketing.