First Non-Stimulant ADHD Medication Available in the United Kingdom
June 03 2004 - 10:00AM
PR Newswire (US)
First Non-Stimulant ADHD Medication Available in the United Kingdom
U.K. Is the First Country in the European Union to Make Strattera
Available INDIANAPOLIS, June 3 /PRNewswire-FirstCall/ --
Strattera(R) (atomoxetine HCl), a non-stimulant treatment for
attention-deficit hyperactivity disorder (ADHD), is now approved
for use in the United Kingdom and will be available by mid-July.
Strattera is the first and only non-stimulant approved for the
treatment of ADHD in children, adolescents and adults. Before
Strattera's approval, the stimulant methylphenidate was the only
licensed treatment for ADHD in the United Kingdom. "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 treatment," said Dr. Val Harpin, Consultant Pediatrician
from Sheffield Children's NHS Trust located in the U.K. "We will
now be able to offer parents and their children an effective
alternative treatment." "Since Strattera first became available in
the United States in January 2003, more than 1.5 million patients
have been treated with it," said A.J. Allen, M.D., Ph.D., Lilly
Research Laboratories, Eli Lilly and Company. "In addition to being
a non-stimulant, Strattera is an important treatment option because
it reduces ADHD symptoms at school and during family time in the
evenings." According to the National Institute for Clinical
Excellence (NICE), 5 percent of children(1), or 500,000(2)
children, are estimated to suffer from ADHD in the U.K. Strattera,
a selective norephinephrine reuptake inhibitor, demonstrated
significant efficacy in six out of six double-blind, randomized,
placebo- controlled clinical trials submitted to the Medicines and
Healthcare products Regulatory Agency (MHRA). Strattera
demonstrated improvements in the symptoms of ADHD including
inattention, hyperactivity and/or impulsivity in children,
adolescents and adults. This marks the first European approval of
Strattera. Strattera is also currently approved in the United
States, Australia, Mexico, Argentina and additional Latin American
countries. About ADHD ADHD affects 3-7 percent of school-age
children and manifests itself in levels of attention,
concentration, activity, distractibility and impulsivity that are
inappropriate to the child's age(3). In addition, 60 percent of
children with the disorder carry their symptoms into adulthood(4).
Experts estimate 4 percent of adults in the United States, more
than 8 million people, have ADHD.(5,6) About Strattera Prior to the
U.K. approval, the U.S. Food and Drug Administration approved
Strattera on November 26, 2002, for the treatment of ADHD in
children, adolescents and adults. Strattera, a selective
norepinephrine reuptake inhibitor, works differently than other
FDA-approved treatments for the disorder, all of which are
stimulants. It is not known precisely how Strattera reduces ADHD
symptoms, but scientists believe it works by blocking or slowing
reabsorption of norepinephrine, a chemical in the brain considered
important in regulating attention, impulsivity and activity levels.
This keeps more norepinephrine at work in the spaces between
neurons in the brain. Improved efficiency in the norepinephrine
system is associated with improvement in symptoms of ADHD (Pliska,
1996). Strattera should not be taken at the same time as, or within
two weeks of taking, a monoamine oxidase inhibitor (MAOI) or by
patients with narrow angle glaucoma. Patients with a history of
high or low blood pressure, increased heart rate, or any heart or
blood vessel disease should tell their doctor before taking
Strattera. Strattera has not been tested in children less than six
years of age or in geriatric patients. Some children may lose
weight when starting treatment with Strattera. As with all ADHD
medications, growth should be monitored during treatment. Most
people in clinical studies who experienced side effects were not
bothered enough to stop using Strattera. The most common side
effects in children and adolescents in medical studies were upset
stomach, decreased appetite, nausea and vomiting, dizziness,
tiredness and mood swings. In adults, the most common side effects
were constipation, dry mouth, nausea, decreased appetite,
dizziness, problems sleeping, sexual side effects, problems
urinating and menstrual cramps. About Lilly Lilly, a leading
innovation-driven corporation, is developing a growing portfolio of
first-in-class and best-in-class pharmaceutical products by
applying the latest research from its own worldwide laboratories
and from collaborations with eminent scientific organizations.
Headquartered in Indianapolis, Ind., Lilly provides answers --
through medicines and information -- for some of the world's most
urgent medical needs. Additional information about Lilly is
available at http://www.lilly.com/ . For full prescribing
information visit http://www.strattera.com/ . This press release
contains forward-looking statements about the potential of
Strattera for the treatment of ADHD and reflects Lilly's current
beliefs. However, as with any pharmaceutical product, there are
substantial risks and uncertainties in the process of
commercialization. There is also no guarantee that the product will
continue to be commercially successful. For further discussion of
these and other risks and uncertainties, see Lilly's filings with
the United States Securities and Exchange Commission. Lilly
undertakes no duty to update forward-looking statements. (1)
National Institute for Clinical Excellence. Technology Appraisal
Guidance No. 13. Guidance on Use of Methylphenidate (Ritalin,
Equasym) for Attention Deficit/Hyperactivity Disorder (ADHD) in
Childhood. October 2000. (2) Population projections by the
Government Actuary. United Kingdom, 2003. (3) American Psychiatric
Association: Diagnostic and Statistical Manual of Mental Disorders,
fourth edition, text revision, Washington, DC, American Psychiatric
Association, 2000. (4) Schweitzer JB, et al.
Attention-deficit/hyperactivity disorder. Med Clin of North Am.
2001; 85(3):757-777 (5) Murphy K, Barkley, RA. J Atten disord.
1996; 1:147-161. (6) United States Census Summary File; 2000.
(Logo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO DATASOURCE:
Eli Lilly and Company CONTACT: Jennifer Bunselmeyer of Eli Lilly
and Company, cell: +1-317-997-1755, pager: +1-888-462-2576, or
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