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ADD/ADHD News

June 3rd 2004

Licensing of the first non-stimulant treatment for Attention Deficit Hyperactivity Disorder (ADHD) in the UK

Press Statement - 3rd June 2004

First Non-Stimulant ADHD Medication Can Provide Effective 24-Hour Relief from Symptoms in Children and Adolescents

First new class of ADHD medication licensed in 30 years gives families and physicians a new choice

For further information contact:

Eli Lilly and Company Customer Care Line - 01256 315999

Basingstoke, UK, 3rd June 2004: The licensing of the first non-stimulant treatment for Attention Deficit Hyperactivity Disorder (ADHD) in the UK is announced today. Strattera^® (atomoxetine HCI) is a oncedaily medication that can provide effective 24-hour relief from the symptoms of ADHD in children and adolescents.¹ It has been shown to be as effective in relieving the core symptoms of ADHD as the stimulant methylphenidate² (sometimes known as Ritalin^®), the only other class of licensed ADHD treatments.

The launch of the first medication in a new class of treatment for ADHD in more than 30 years has been welcomed by Dr Val Harpin, Consultant Paediatrician from Sheffield Children's NHS Trust,

"Healthcare professionals involved in the care of children with ADHD have long expressed a desire to be able to offer parents an alternative to stimulant treatments. We will now be able to offer parents and their children an effective alternative treatment."

As a non-stimulant, there is no evidence of abuse potential for Strattera,^3,4 a concern that some doctors have about current ADHD medication. This concern may be reflected in current prescribing patterns which show that just 22%⁵ of the 5%⁶ or 500,0007 children estimated by NICE as suffering from ADHD currently receive treatment.

Children with ADHD can be very disruptive which can be challenging for parents, as Charmaine Wainwright, whose son is diagnosed with ADHD, explained, "Bringing up a child with ADHD is not just a case of having to cope with him being fidgety or not being able to concentrate for half an hour or so.

ADHD is a condition that affects all aspects of our whole family's life all of the time. Breakfast can be very stressful as it is often a struggle to get him to sit still and eat, and calming him down for bedtime is nearly impossible. My son has also found it hard to interact with his classmates, which meant that he has few friends and never gets invited to activities outside of school such birthday parties. As a parent this can be one of the most upsetting aspects of the condition."

Andrea Bilbow, Chief Executive of ADDISS commenting on the broader impact of ADHD said,

"It affects everybody, it affects the child who has the condition to the family around them, their siblings, their friends, the school environment, the classmates, the teachers. It has a huge impact on everyone in the community."

Dr David Coghill, Senior Lecturer in Child and Adolescent Psychiatry, University of Dundee, said,

"Continuous relief from the symptoms of ADHD is something we've not seen before. Current treatments are often only taken to provide cover during the school day and early evening leaving families to face the challenges of living with an untreated child early in the morning and later in the evening. Continuous relief from symptoms may allow children and their families the opportunity to live a more normal life with respite from the disruption of ADHD."

Strattera, a highly selective noradrenaline reuptake inhibitor (NRI), consistently demonstrated significant efficacy in six out of six double-blind, randomised, placebo-controlled clinical trials submitted to the Medicines and Healthcare Products Regulatory Agency (MHRA).^{1,10,11,12,13} It demonstrated improvements in the symptoms of ADHD including inattention, hyperactivity and impulsivity in children, adolescents and adults. Strattera is licensed in the UK for the treatment of ADHD in children aged six years and older, adolescents and adults ³ and will be available in the UK from mid-July. Strattera was first launched in the US in January 2003, and more than 5 million prescriptions have been written for over 1.5 million patients globally to date.

About Strattera

o Manufactured by Eli Lilly and Company, Strattera is also currently available in the US, Australia, Mexico and Argentina. Strattera has also been submitted for approval in New Zealand, Brazil and Europe
o Strattera is available in 10, 18, 25, 40 and 60mg doses
o Initial symptom reduction may be seen in the first week, with near maximum symptom reduction achieved from at least four weeks of treatment¹¹
o As a non-stimulant, Strattera is not classed as a controlled drug. Patients receiving controlled drugs, such as stimulants, need to see a healthcare professional for every repeat prescription
o Strattera is not a psychostimulant or an amphetamine derivative and has no activity in the area of the brain related to addiction
o Scientists believe Strattera works by blocking reuptake of the neurotransmitter noradrenaline, a chemical used to signal between nerve cells in the brain which is thought to be important in regulating attention, impulsivity and activity levels
o The most common side effects include appetite loss, headache and stomach ache and were generally mild to moderate and transient³

About Eli Lilly and Company Eli Lilly and Company, a leading innovation-driven company is developing a growing portfolio of best in class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organisations. Headquartered in Indianapolis, Indiana, USA. Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs.

References

1. Kelsey D et al. Once-daily atomoxetine in childhood ADHD: continuous symptom relief. Poster and abstract presented at American Psychiatric Association (APA) 156th Annual Meeting, San Francisco, California, May 17 - 22, 2003
2. Kratochvil CJ et al. Atomoxetine and Methylphenidate Treatment in children with ADHD: a prospective, randomized, open-label trial. J Am Acad Child Adolesc Psych 2002; 41(7):776-784
3. Strattera Summary of Product Characteristics, May 2004
4. Bymaster FP et al. Atomoxetine increases extracellular levels of norephinephrine and dopamine in prefrontal cortex of rat: a potential mechanism for efficacy in attention deficit/hyperactivity disorder. Neuropsychopharmacology 2002; 27(5); 699-711
5. As assessed by Lilly UK using IMS Disease Analyser - Mediplus UK Data BPI/HPAI Unit sales, IMS April 2004; AVDD, IMS Disease Analyser, April 2004
6. National Institute for Clinical Excellence. Technology Appraisal Guidance - No. 13. Guidance on the Use of Methylphenidate (Ritalin, Equasym) for Attention Deficit/Hyperactivity Disorder (ADHD) in childhood. October 2000
7. Population projections by the Government Actuary. United Kingdom, 2003
8. Sangal RB et al. Effects of atomoxetine and methylphenidate on sleep in children with ADHD. Poster and abstract presented at American Psychiatric Association (APA) 157th Annual Meeting, New York, USA, 1-6 May, 2004
9. Barton J et al. 10-week open-label acute treatment in non-North American children with ADHD. Poster presented at Royal College of Psychiatry Annual Meeting, 2003
10. Michelson D et al. Atomoxetine in the Treatment of Children and Adolescents with Attention Deficit/Hyperactivity Disorder: A Randomized Placebo Controlled, Dose Response Study. Pediatrics 2001; 108(5): E83
11. Michelson D et al. Once-daily atomoxetine treatment for children and adolescents with attention deficit hyperactivity disorder: a randomized, placebo-controlled study. Am J Psych 2002; 159: 1896-1901
12. Weiss M et al. Placebo-controlled study of once-daily atomoxetine in the school setting. Abstract presented at American Academy of Child & Adolescent Psychiatry (AACAP), Miami, Florida, USA, 14-19 October, 2003
13. Spencer T et al. Results from 2 proof-of-concept, placebo-controlled studies of atomoxetine in children with attention-deficit/hyperactivity disorder. J Clin Psychiatry 2002; 63(12): 1140-1147
14. IMS Market DynamicsTM Custom Solutions, April 2004
15. American Psychiatric Association. DSM-IV Text Revision. 2000: 85-93
16. Ralston SJ. European Health Outcomes Research, European Operations, Eli Lilly and Company, MEDTAP International Inc, ECNP 2002

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