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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.
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DATASOURCE: Eli Lilly and Company
CONTACT: Jennifer Bunselmeyer of Eli Lilly and Company, cell:
+1-317-997-1755, pager: +1-888-462-2576, or