ViroPharma's Buccolam®▼ (Midazolam, Oromucosal Solution) now Available in the United Kingdom as Licenced Product for Emergency Treatment of Seizures in Children and Adolescents

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ViroPharma Incorporated

12 Dec, 2011, 09:00 GMT

EXTON, Pennsylvania, December 12, 2011 /PRNewswire/ --

Clinicians and carers of children and adolescents suffering from prolonged, acute, convulsive seizures now have access to Buccolam® (midazolam oromucosal solution), a newly approved rescue medication to treat prolonged, acute, convulsive seizures in infants, toddlers, children and adolescents, from 3 months to less than 18 years of age.[1] For infants between three to six months of age, treatment should be in a hospital setting where monitoring is possible and resuscitation equipment is available. Buccolam must only be used by parents/carers where the patient has been diagnosed to have epilepsy,[1] of whom there are an estimated 60,000 under 18 years of age in the United Kingdom.[2] Buccolam is marketed in the UK by a wholly-owned subsidiary of ViroPharma Incorporated (Nasdaq: VPHM).

"The rapid, effective management of prolonged convulsive seizures is potentially life-saving, and the use of oromucosal (buccal) midazolam for this is increasingly recognised as an important part of the comprehensive management of epilepsy, with a potential for avoiding hospital admission," commented Professor Stephen Brown, retired consultant neuropsychiatrist. "There are further important advantages over rectal diazepam as the oromucosal route helps preserve the dignity of the patient and the short half-life enables a more rapid recovery and faster return to normal activities."

"Unfortunately, the number of children with epilepsy who continue to have seizures despite optimal medical care is high. Many can have clusters of seizures and/or very prolonged seizures, and these have a high associated morbidity and mortality. These risks can be substantially reduced through timely intervention with benzodiazepine rescue preparations in the community," commented Professor Matthew Walker of the UCL Institute of Neurology. "Until now the only licensed formulation for such use has been rectally-administered diazepam which, while effective, presents certain social and practical challenges. The approval of Buccolam provides a welcome alternative for clinicians, nurses, carers and families caring for children with epilepsy."

Buccolam is oromucosal midazolam provided in a pre-filled, age-specific dose formulation for convenient buccal (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 pediatric convulsive seizures.[3,4,5,6]

The licensing and availability of Buccolam follows its recent central approval in the European Union through the Pediatric Use Marketing Authorization (PUMA) process on 5 September 2011.[7] Buccolam is the first product approved using a PUMA, which is a type of centralized marketing authorization procedure requested for medicines already authorized but no longer covered by intellectual property rights and exclusively developed for use in children.

Eric Vick, ViroPharma General Manager for the UK, Ireland and Nordic countries commented: "At ViroPharma we are committed to delivering novel solutions that address critical gaps in care for patients in the UK living with few, if any, clinical treatment options. We are excited to now be working closely with healthcare providers and carers to bring an effective and convenient emergency solution to children and adolescents 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 a convenient, portable, ready to use, pre-filled oral syringe containing an age-specific dose. 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.[1] Buccolam must only be used by parents/carers where the patient has been diagnosed to have epilepsy. For infants between 3-6 months of age, treatment should be in a hospital setting where monitoring is possible and resuscitation equipment is available.[1]

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.[1]

The most common adverse reactions in clinical trials associated with oromucosal midazolam were sedation, somnolence, depressed levels of consciousness, respiratory depression, and nausea and vomiting. No severe adverse events were reported. The safety profile was similar to rectal or intravenous diazepam in the comparative clinical trials.[1]

About Non-Epileptic and Epileptic Seizures

Seizures occur because of sudden and abnormal electrical activity in the brain. There are many causes of seizures affecting pediatric patients; many are the result of epilepsy, but other triggers can include 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.[8] Epilepsy is among the most common childhood neurological disorders in developed countries, affecting nearly one percent of the population.[9] There are approximately six million people affected by epilepsy in Europe;[10] nearly one million European children and adolescents have active epilepsy.[11] Epilepsy commonly causes physical manifestations including neurological and muscle destruction and degradation of renal function, as well as numerous negative cognitive, behavioral and neurological effects. Seizures can last from a few seconds to several minutes or longer in some cases. If left untreated, seizures can lead to status epilepticus (SE) and patients may require hospitalization and intensive care.

About ViroPharma Incorporated

ViroPharma Incorporated is an international biopharmaceutical company committed to developing and commercializing novel 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.

Forward-Looking Statements

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 our 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 the UK will be successful. The commercial success of Buccolam in the UK 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 the UK 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, 2010 and quarterly reports on Form 10-Q filed with the Securities and Exchange Commission for the periods ended March 31, 2011, June 30, 2001 and September 30, 2011, 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.
  2. Epilepsy Society. Children and education - A guide for parents and teachers. Available at: http://www.epilepsysociety.org.uk/AboutEpilepsy/Epilepsyandyou/Childrenandeducation-1?gclid=COXKtKS5x6kCFY8o3wod7XEvbg. Last accessed 24 November 2011.
  3. Scott RC, et al. Buccal midazolam and rectal diazepam for treatment of prolonged seizures in childhood and adolescence: a randomised trial. Lancet 1999;353:623-6.
  4. McIntyre J, et al. Safety and efficacy of buccal midazolam versus rectal diazepam for emergency treatment of seizures in children: a randomised controlled trial. Lancet 2005;366:205-10.
  5. Baysun S, et al. A comparison of buccal midazolam and rectal diazepam for the acute treatment of seizures. Clin Pediatr 2005;44:771-6.
  6. 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.
  7. European public assessment report (EPAR) for Buccolam . Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/002267/WC500112313.pdf. Last accessed 24 November 2011.
  8. 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 24 November 2011.
  9. Ekinci, O, et al. Depression and anxiety in children and adolescents with epilepsy: Prevalence, risk factors, and treatment. Epilepsy Behav 2009;14:8-18.
  10. Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe. 2010. Available at: http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf. Last accessed 24 November 2011.
  11. Forsgren L, et al. The epidemiology of epilepsy in Europe - a systematic review. Eur J Neurol 2005;12:245-53. Available at: http://www.ncbi.nlm.nih.gov/pubmed/15804240. Last accessed 24 November 2011.

VIROPHARMA INCORPORATED Contacts:

Eric Vick
General Manager, UK, Ireland and Nordic countries
Phone +44(0)1628-509654

Kristina M. Broadbelt (Media Enquiries)
Associate Director, PR & Advocacy
Phone +1(610)321-2358