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February 26th 2002 - 22:00 GMT

Concerta^® XL Now Licensed In The UK

Janssen-Cilag, patient/carer orientated web-site., part of the well known Johnson & Johnson Group, today announced the launch of Concerta^® XL in the UK. This medication for ADD/ADHD is a long acting one dose per day which lasts up to 12 hours, claim the makers. Concerta^® was previously available in the United States and has been available in the UK on a named patient basis only since June last year as reported on adders.org news. It has now however been officially licensed in the UK, though only for children and adolescents, and the press release from Janssen-Cilag was as follows:

Janssen-Cilag Announces Launch of 12-hour Concerta^® XL
Once-Daily Medication for Attention Deficit Hyperactivity Disorder (ADHD)
New treatment offers children relief from 'home to homework'

25 February 2002 - Janssen-Cilag's Concerta^® XL (methylphenidate HCI), the only once-daily treatment for ADHD, is now launched for use in adolescents and children as young as six. Concerta^® XL effectively controls ADHD symptoms for 12 hours, eliminating the need for children to take medication during or after school hours.

"ADHD is a medical condition that can cause serious disruptions to a child's life at home or at school, preventing their ability to perform academically, be accepted by their peers and to integrate into their families," says Dr Peter Hoare, Consultant Child Psychiatrist at the Royal Hospital for Sick Children, Edinburgh. "ADHD requires proper diagnosis and treatment, and an effective, once-daily therapy should improve both acceptance and compliance."

A recent study of children aged 6-12 with ADHD compared Concerta^® XL to placebo (an inactive pill) and immediate-release methylphenidate administered three times a day considered the 'standard of care' in the past. Compared to placebo, Concerta^® XL and immediate-release methylphenidate were equally effective at significantly improving children's productivity and accuracy when completing assignments such as arithmetic, reducing disruptive behaviour and increasing their ability to stay 'on-task.' However, significantly, more parents said that they preferred Concerta^® XL over three times daily methylphenidate.¹

Commenting on the launch of Concerta^® XL, Dr Robert Donnelly, Medical Director, Janssen-Cilag, UK, says, "Up until now, there has been no once-daily treatment for ADHD in the UK that is effective for 12 hours, which means that children with this condition must take medication during school hours or extra curricular activities. This can be difficult to remember and implement during busy school routines, and can be hard on the self esteem of children."

ADHD is characterised by an excessive inability to concentrate and pay attention and/or hyperactivity-impulsivity. It is estimated that ADHD affects approximately five percent (345,000 in England and 21,000 in Wales) of school age children in the UK.² Drug treatment is part of an overall management programme that includes psychological, educational and social measures.

"Children with ADHD who don't receive a proper diagnosis have a high likelihood of suffering from behavioural problems into adulthood, often resulting in social rejection, lack of gainful employment and even clashes with the law," explains Andrea Bilbow, Head of ADDISS, a leading UK ADHD patient/family support group, "A new option like Concerta^® XL helps assure that these children get the consistent treatment they need to overcome these challenges."

Concerta^® XL is an extended-release formulation of methylphenidate, which uses the OROS^®* tri-layer drug-delivery system. Osmotic pressure delivers medication into the bloodstream at a slow, sustained rate, minimising the fluctuations associated with conventional or immediate release products, such as Ritalin^®**.

In the U.S. Concerta was approved by the Food and Drug Administration (FDA) to treat ADHD in adolescents and children aged six and older on 1 August 2000. In the U.S. Concerta has been well received by patients and physicians and is the most widely prescribed branded methylphenidate extended release formulation.³

In the United Kingdom, the Medicines Control Agency (MCA) approved Concerta^® XL on 19 February 2002. The UK will serve as the reference member state for the mutual-recognition of Concerta XL in the European Union.

Concerta XL was developed by Alza Corp., now a member of the Johnson & Johnson [NYSE: JNJ] family of companies along with Janssen-Cilag. The product will be marketed in the European Union by Janssen-Cilag, which has a long track record in developing and marketing treatments for central nervous system disorders. Other speciality areas of Janssen-Cilag include treatment of psychiatric conditions such as schizophrenia, neurological disorders such as Alzheimer's disease, chronic pain, fungal infections and gastrointestinal conditions.

*OROS^® technology uses osmotic pressure to deliver medication at a controlled rate. OROS^® technology features a semi-permeable rate-controlling membrane surrounding an osmotic core, which contains two layers: a push compartment and a drug compartment. Once the tablet is swallowed and is in the gastrointestinal tract, the drug overcoat dissolves which provides an immediate release of 22% of the entire dose of methylphenidate. When the overcoat dissolves, water enters the membrane and the push compartment expands which initiates a controlled release of the drug from the drug compartment through a tiny laser drilled hole at the end of the tablet at a controlled rate.

** Ritalin^® is a registered trademark of Novartis.

References

1 Pelham WE, Gnagy, EM, Burrows-Maclean L et al. Once-a-day Concerta methylphenidate vs three times daily methylphenidate in laboratory and natural settings. Paediatrics 2001107(6):1-15
2 National Institute for Clinical Excellence (NICE). Guidance on the use of methylphenidate for attention deficit hyperactivity disorder (ADHD) in childhood. Technology Appraisal Guidance. October 2000.
3 Data on file

Simon Hensby for adders.org

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