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Non-stimulant Strattera More Widely Available for Attention-
Deficit/Hyperactivity Disorder in Children and Adolescents in Europe
Europe's only approved non-stimulant ADHD medication offers a new treatment
choice
INDIANAPOLIS, May 18 /PRNewswire-FirstCall/ -- Eli Lilly and Company's
Strattera(R) (atomoxetine HCl), the only approved non-stimulant medication
proven clinically effective at treating the symptoms of attention-
deficit/hyperactivity disorder (ADHD), is now more widely available in Europe,
following marketing authorizations granted by regulatory authorities in
Germany, The Netherlands and Norway. Strattera is approved for the treatment
of ADHD in children and adolescents in these countries.
A selective norepinephrine reuptake inhibitor, Strattera represents the first
new class of ADHD medications in the 50 years since stimulant medications first
began being used. Strattera became available in Germany in March 2005 and
became available in The Netherlands and Norway in April. Within Europe,
Strattera was previously approved for use in the United Kingdom by the UK's
Medicines and Healthcare Products Regulatory Agency in May 2004.
In clinical trials, Strattera demonstrated effective, continuous relief of core
ADHD symptoms, including inattention and/or hyperactivity and impulsivity, from
morning until late evening. Strattera treats ADHD without causing insomnia in
most children and adolescents and can be used in patients who have other
co-existing conditions such as tics and anxiety.
"Strattera provides physicians and families with something they've never had
before -- a proven effective, non-stimulant option for the treatment of ADHD,"
said Dr. Jesus Hernandez, Executive Director of Clinical Research and
Regulatory Affairs in European Operations at Eli Lilly and Company. "Through
this new class of ADHD treatment, we are living up to Lilly's commitment to
provide patients innovative new medications. We are very pleased that more
doctors in Europe will be able to consider Strattera as a part of a
comprehensive ADHD treatment program."
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.(1)
A biological, brain-based condition, ADHD is thought to be caused by an
imbalance of some of the brain's neurotransmitters, which are the substances
used to signal between nerve cells.(1) The condition is characterized by
hyperactive/impulsive behaviors and/or attention-deficit problems that cannot
be explained by any other psychiatric condition and are not in keeping with the
child's intellectual ability or stage of development.(2)
Studies have shown that more than 50 percent of children with untreated ADHD
have poor peer relationships and that families of children with ADHD experience
greater stress.(3) If the disorder is not appropriately treated, these
children are much less likely to finish college, and are more likely to develop
drug use disorders (20-32 percent) and to hold less skilled jobs in
adulthood.(3)
About Strattera
Strattera, a selective norepinephrine reuptake inhibitor, is the first FDA
approved non-stimulant to treat ADHD and provide full-symptom relief. 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 6
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. Strattera can cause liver damage in rare cases.
Patients should tell their doctor right away if they have itching, dark urine,
yellow skin/eyes, upper right-sided abdominal tenderness, or unexplained
"flu-like" symptoms.
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/ . P-LLY
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. 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) American Psychiatric Association: Diagnostic and Statistical Manual of
Mental Disorders, fourth edition, text revision, Washington, DC, American
Psychiatric Association, 2000.
(2) Green C, Chee K. Understanding ADHD - The Definitive Guide to Attention
Deficit Hyperactivity Disorder. The Random House Ballantine Publishing Group
1998.
(3) Barkley RA. Attention-Deficit Hyperactivity Disorder: A Handbook for
Diagnosis and Treatment. 1998, Guildford Publications, New York.
(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, +1-317-655-8808