Market Wire - FDA Approves Strattera(R) for Maintenance of ADHD in Children and Adolescents
Eli Lilly and Company (NYSE: LLY)
announced today that the United States Food and Drug Administration (FDA)
has approved Strattera (atomoxetine HCI) for maintenance treatment of
Attention-Deficit/Hyperactivity Disorder (ADHD) in children and
adolescents. Strattera, a selective norepinephrine reuptake inhibitor, is
the first FDA-approved non-stimulant to treat ADHD in children, adolescents
and adults.
“The approval provides physicians and their patients with the first
treatment option that is indicated for maintenance of ADHD,” said Thomas J.
Spencer, M.D., Associate Professor of Psychiatry, Harvard Medical School.
“This is critical as ADHD may be a life-long disease and effective
long-term control of symptoms may mean improved outcomes in children and
adolescents.”
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The safety and efficacy of Strattera in the maintenance of ADHD was
demonstrated in one of the largest relapse prevention studies ever
conducted in ADHD, which is one of the most common mental health disorders
in children and adolescents.(1)
The 18-month trial of about 600 children and adolescents aged six to 15
years, who met DSM-IV (Diagnostic and Statistical Manual of Mental
Disorders) criteria for ADHD, showed Strattera was superior to placebo in
maintaining continuous efficacy in patients, as measured by the ADHD Rating
Scale (ADHD-RS). Additionally, at the end of the trial, patients taking
Strattera had lower relapse rates (2.5 percent) as compared to patients
taking placebo (12.2 percent).
Strattera provides uninterrupted relief from ADHD symptoms throughout the
day into the evening. This is important since the symptoms of ADHD go
beyond the work and school day. ADHD patients can experience frustration,
low self-esteem, difficulty with relationships and increased lifestyle
risks.
“In the past, our understanding of ADHD treatment was limited to clinical
data on short-term use, meaning a few weeks or a couple of months,” said
A.J. Allen, M.D., Ph.D., Strattera global medical director for Eli Lilly
and Company. “For the first time, clinicians have guidance that Strattera
is effective for up to a year in patients who respond well to initial
treatment.”
The long-term, international, multi-center study, which was reviewed by the
FDA as part of its decision to grant this approval, employed a treatment
discontinuation design (3 months of acute open-label treatment followed by
up to 15 months of placebo controlled maintenance treatment) that enabled
investigators to test the efficacy of Strattera as maintenance therapy. In
the study, 604 patients initially received acute open label treatment with
Strattera. After 10-weeks, 69% of patients qualified as responders and
were re-randomized to double-blind treatment with either Strattera or
placebo for nine months. A second six-month randomization occurred after
approximately one year of treatment with 81 patients taking Strattera and
82 patients in the placebo group.
Results of both randomization phases showed that patients treated with
Strattera had significantly greater continuous response rates versus
patients taking placebo. For child and adolescent ADHD patients with a good
initial response to Strattera and who continued to respond well for 1 year,
97.5% maintained response on Strattera vs. 87.8% on placebo (relapse rates
2.5% for Strattera vs. 12.2% for placebo). Additionally, relapse rates for
those discontinuing treatment after one year were lower than the relapse
rates for patients who discontinued treatment during the 6 months following
the open label treatment phase (Strattera, 61/292 [20.9%]; placebo, 46/124
[37.1%]).
Strattera was generally well-tolerated. The most common side effects
reported in the study were headache and the common cold (nasopharyngitis).
In the study, the mean final dose of Strattera was approximately 1.54
mg/kg/day after 12 months and 18 months treatment. There were no
significant differences in standardized height change between groups during
the post-randomization period.
About ADHD
ADHD is the most common psychiatric disorder to appear in childhood. If
left untreated, ADHD can have long-term effects on a child’s emotional
well-being and social skills, like making friends or doing well at school
or at work.(2) ADHD can also have lifelong consequences, including poor
peer relations, poor academic and work performance and increased
risk-taking behaviors, such as substance abuse.(3)
About Strattera
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.(4) Since its first approval in the United States in 2002, more than 5
million patients have taken Strattera worldwide. It has been studied in
more than 6,000 patients in clinical trials, some for as long as three
years.
