EXTON, Pennsylvania, June 27, 2012 /PRNewswire/ --
ViroPharma Incorporated (Nasdaq: VPHM) has announced today that Buccolam® (midazolam, oromucosal solution) is approved for reimbursement by the Health Services Executive (HSE) in Ireland and is available through the national health system for children and adolescents, from three months to less than 18 years of age, who suffer from prolonged, acute, convulsive seizures. In Ireland, there are up to 42,000 patients with epilepsy and it is estimated that one in every 200 children has the condition.[2,3] For children aged between five and 18 years old, the national prevalence is between three and five people in every 1,000, or up to 5,000 in total.
For infants between three to six months of age, treatment with Buccolam must be administered in a hospital setting where monitoring is possible and resuscitation equipment is available. Buccolam must only be used by parents or carers where the patient has been diagnosed to have epilepsy.
"Buccolam, as a licensed preparation of buccal midazolam for emergency treatment of prolonged seizures, is a welcome additional option for care of children with epilepsy," commented Dr Bryan Lynch, Consultant Paediatric Neurologist at the Children's University Hospital in Dublin.
Buccolam is oromucosal midazolam provided in a pre-filled, age-specific dose formulation for convenient buccal cavity (i.e. via the cavity between the cheek and gum) delivery. Oromucosal 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 licensed treatment, rectally-administered diazepam, for terminating paediatric convulsive seizures.[4,5,6,7]
"The availability of a further emergency medication within Ireland is good news for parents and carers of children with epilepsy," commented Mike Glynn, CEO of Brainwave, The Irish Epilepsy Association. "It provides a practical means of treating young people at risk of prolonged, acute seizures in the community. We support parents and carers in their wish for an emergency treatment for young people that is simple to use and may reduce the number of hospitalisations."
In September 2011, Buccolam was approved in the European Union through the Paediatric Use Marketing Authorisation (PUMA). Buccolam is the first medicine approved using a PUMA, which is a type of centralised marketing authorisation procedure requested for medicines exclusively developed for use in children that are already authorised, but no longer covered by patents.
Matthew Mason, ViroPharma General Manager for the UK and Ireland, commented: "At ViroPharma we are committed to delivering solutions that address critical gaps in care for patients living with few, if any, clinical treatment options. We will continue to work closely with healthcare providers and carers to bring an effective and convenient emergency solution to as many children and adolescents as possible, who suffer from recurrent prolonged seizures."
About Buccolam®(Midazolam, Oromucosal Solution)
Buccolam is oromucosal midazolam provided in an individual dose formulation for buccal delivery. It is provided as convenient, portable, ready to use, pre-filled oral syringes containing age-specific doses. Buccolam is approved throughout the European Union and the EEA for treatment of prolonged, acute, convulsive seizures in infants, toddlers, children and adolescents, from three months to less than 18 years of age.
Buccolam must only be used by parents or carers where the patient has been diagnosed to have epilepsy. For infants between three and six months of age, treatment must be in a hospital setting where monitoring is possible and resuscitation equipment is available.
Hypersensitivity to midazolam, benzodiazepines or to any of the excipients may occur. Midazolam should be used with caution in patients with chronic respiratory insufficiency because midazolam may further depress respiration. Midazolam should be used with caution in patients with chronic renal failure, impaired hepatic or cardiac function. Midazolam may accumulate in patients with chronic renal failure or impaired hepatic function, whilst in patients with impaired cardiac function it may cause decreased clearance of midazolam.
The most common adverse reactions in clinical trials associated with oromucosal midazolam were sedation, somnolence, depressed levels of consciousness, respiratory depression, nausea and vomiting. No severe adverse events were reported. The safety profile was similar to rectal or intravenous diazepam in the comparative clinical trials.
About Non-Epileptic and Epileptic Seizures
Seizures are a result of sudden and abnormal electrical activity in the brain. There are many causes of seizures affecting paediatric patients; many are the result of epilepsy, but other triggers can include certain medicines, head injuries, certain diseases, and high fevers (called 'febrile seizures'). Febrile seizures are the most common type of seizure in children; approximately one in every 25 children will have at least one febrile seizure, and more than one-third of these children will have additional febrile seizures before they outgrow the tendency to have them. Epilepsy is among the most common childhood neurological disorders in developed countries, affecting nearly one percent of the population. There are approximately six million people affected by epilepsy in Europe; nearly one million European children and adolescents have active epilepsy. Epilepsy commonly causes physical manifestations including neurological and muscle destruction and degradation of renal function, as well as numerous negative cognitive, behavioural and neurological effects. Seizures can last from a few seconds to several minutes or longer in some cases. If left untreated, prolonged, acute, convulsive seizures may lead to status epilepticus (SE) and patients may require hospitalisation and intensive care.
About ViroPharma Incorporated
ViroPharma Incorporated is an international biopharmaceutical company committed to developing and commercialising solutions for physician specialists to address unmet medical needs of patients living with diseases that have few, if any, clinical therapeutic options, including C1 esterase inhibitor deficiency, treatment of seizures in children and adolescents, adrenal insufficiency, and C. difficile infection (CDI). Our goal is to provide rewarding careers to employees, to create new standards of care in the way serious diseases are treated, and to build international partnerships with the patients, advocates, and healthcare professionals we serve.
ViroPharma routinely posts information, including press releases, which may be important to investors in the investor relations and media sections of our company's website, http://www.viropharma.com/. The company encourages investors to consult these sections for more information on ViroPharma and our business.
Certain statements in this press release contain forward-looking statements that involve a number of risks and uncertainties. Forward-looking statements provide our current expectations or forecasts of future events, including physician and patient acceptance of Buccolam and the estimated number of patients that may experience non-epileptic and epileptic seizures. There can be no assurance that our commercial launch of Buccolam in Ireland will be successful. The commercial success of Buccolam in Ireland will depend on a number of factors including the actual number of patients that may experience non-epileptic and epileptic seizures, physician and patient acceptance of Buccolam, the timing and level of pricing approvals obtained in Ireland and the level of manufacturing and supply of Buccolam produced by third-party manufacturers. These factors, and other factors, including, but not limited to those described in our annual report on Form 10-K for the year ended December 31, 2011 and quarterly reports on Form 10-Q filed with the Securities and Exchange Commission for the period ended March 31, 2012 could cause future results to differ materially from the expectations expressed in this press release. The forward-looking statements contained in this press release are made as of the date hereof and may become outdated over time. ViroPharma does not assume any responsibility for updating any forward-looking statements. These forward-looking statements should not be relied upon as representing our assessments as of any date subsequent to the date of this press release.
1. Buccolam European Summary of Product Characteristics. September 2011.
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3. Brainwave: The Irish Epilepsy Association. Epilepsy in Children. Available at: http://www.epilepsy.ie/index.cfm/spKey/info.epilepsy_in_children.html. Last accessed June 2012.
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7. Mpimbaza A, et al. Comparison of buccal midazolam with rectal diazepam in the treatment of prolonged seizures in ugandan children: a randomized clinical trial. Pediatrics 2008;121:e58-64.
8. European public assessment report (EPAR) for Buccolam . Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/002267/WC500107989.pdf. Last accessed June 2012.
9. National Institute of Neurological Disorders and Stroke. Febrile Seizures Fact Sheet. Available at: http://www.ninds.nih.gov/disorders/febrile_seizures/detail_febrile_seizures.htm. Last accessed June 2012.
10. Ekinci, O, et al. Depression and anxiety in children and adolescents with epilepsy: Prevalence, risk factors, and treatment. Epilepsy Behav 2009;14:8-18.
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12. Forsgren L, et al. The epidemiology of epilepsy in Europe - a systematic review. Eur J Neurol 2005;12:245-53.
ViroPharma Incorporated Contacts:
General Manager, UK and Ireland
Kristina M. Broadbelt (Media Enquiries)
Associate Director, PR & Advocacy
SOURCE ViroPharma Incorporated