EXTON, Pennsylvania, February 14, 2012 /PRNewswire/ --
- New Treatment Option for Children and Teens under 18 Now Available for Use by NHS Scotland -
Clinicians and carers of infants, children and adolescents from 3 months to <18 years suffering from prolonged, acute, convulsive seizures now have access to Buccolam® (midazolam, oromucosal solution) through NHS Scotland, following the approval from the Scottish Medicines Consortium (SMC). Buccolam will be marketed in Scotland by ViroPharma Limited, a wholly-owned subsidiary of ViroPharma Incorporated (NASDAQ: VPHM). The full advice reads as follows:
ADVICE: Following a full submission midazolam oromucosal solution (Buccolam®) is accepted for use within NHS Scotland.
Indication under review: Treatment of prolonged, acute, convulsive seizures in infants, toddlers, children and adolescents (from 3 months to <18 years).
Midazolam given via the buccal route was considered at least non-inferior to rectally administered benzodiazepine in terminating acute prolonged seizures.
The economic case was demonstrated for midazolam oromucosal solution (Buccolam®) compared to rectal diazepam.
Midazolam has anti-convulsant, sedative, and muscle-relaxant effects and is effective when given by the oromucosal route, i.e. administered to the space between the cheek and gums to be absorbed through the membrane lining of the mouth (buccal administration).
This class of medicine is considered a welcome alternative to the rectal administration of diazepam, a widely used treatment in Europe.
In the UK, various midazolam preparations have been used in children as unlicensed medicines over the years, and until recently, no licensed preparation was available. In September 2011, Buccolam became the first product to receive a licence via the Paediatric Use Marketing Authorization (PUMA) procedure, designed specifically to encourage the development of medicines for children. Buccolam is thus the first buccal midazolam to be licensed for the treatment of prolonged, acute, convulsive seizures in children up to the age of 18. The Medicines and Healthcare products Regulatory Agency (MHRA) has been advocating for the increased availability of "specific children's-only medicines for several years in recognition that many adult medicines are offered to children in cut-down doses".
"The SMC's approval of Buccolam as an emergency medication is welcome news for hundreds of families and clinicians in Scotland," commented Lesslie A Young, Chief Executive of Epilepsy Scotland. "We are delighted that this licensed drug is now available to treat infants to teenagers with severe and prolonged epileptic seizures. The addition of a new prescription drug in the medical armoury will help doctors to provide optimum care for young people living with difficult and life-threatening seizures."
Thierry Darcis, ViroPharma's general manager, Europe 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 are now working closely with healthcare providers and carers across Europe to bring this effective and convenient emergency solution to children and adolescents who suffer from recurrent prolonged, acute, convulsive 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/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.
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, 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.
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 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, 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 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 in Scotland that may experience non-epileptic and epileptic seizures. There can be no assurance that our commercial launch of Buccolam in Scotland will be successful. The commercial success of Buccolam in Scotland will depend on a number of factors including the actual number of patients in Scotland that may experience non-epileptic and epileptic seizures, physician and patient acceptance of Buccolam, the timing and level of pricing approvals obtained in EU member states 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 10-Q filings for the quarters ended March 31, 2011, June 30, 2011, and September 30, 2011 filed with the Securities and Exchange Commission, 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. Scottish Medicines Consortium advice: midazolam, 5mg/mL, oromucosal solution (Buccolam®) SMC No. (757/12). Available at: http://www.scottishmedicines.org.uk/files/advice/midazolam_Buccolam_FINAL_Jan_2012_Amended_310112_for_website.pdf. Last accessed 13 February 2012.
2. MHRA Drug Safety Update. October 2011. Available at: http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON131931. Last accessed 13 February 2012.
3. 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 13 February 2012.
4. MHRA Press release: A big step forward for better children's medicines. 7 September 2011. Available at: http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON129006. Last accessed 13 February 2012.
5. Buccolam European Summary of Product Characteristics. June 2011.
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7. Ekinci, O, et al. Depression and anxiety in children and adolescents with epilepsy: Prevalence, risk factors, and treatment. Epilepsy Behav 2009;14:8-18.
8. Epilepsy in the WHO European Region: Fostering Epilepsy Care in Europe. 2010. Available at: http://www.ibe-epilepsy.org/downloads/EURO%20Report%20160510.pdf [http://www.ibe-epilepsy.org/downloads/EURO Report 160510.pdf]. Last accessed 13 February 2012. 9. 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 13 February 2012.
ViroPharma Incorporated Contacts:
General Manager, UK, Ireland and Nordic countries
Kristina M. Broadbelt (Media)
Associate Director, PR & Advocacy
SOURCE ViroPharma Inc