Non-stimulant Strattera More Widely Available for Attention- Deficit/Hyperactivity Disorder in Children and Adolescents in Europ
May 18 2005 - 9:00AM
PR Newswire (US)
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
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