Home » Drug Information » FDA-Approved Drugs » 2001
Medical Areas: Pediatrics/Neonatology | Psychiatry/Psychology
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Drug Information
The following information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Shire Pharmaceuticals
Approval Status: Approved October 2001
Treatment Area: Attention deficit/hyperactivity disorder (ADHD)
Adderall XR, an extended release formulation of Shire's
previously approved ADHD treatment Adderall, has been approved for
treatment of ADHD in children. This once-daily capsule provides all
day treatment with one morning dose, unlike most ADHD treatments
that require a midday dose. This dosing regimen eliminates the
social stigma issues felt by children having to bring medication to
school and decreases the possibility of medication misuse.
ADHD is the most commonly diagnosed psychiatric disorder among
school-aged children. Symptoms include inattentive, impulsive and
hyperactive behavior that interferes with a child's ability to
properly function in academic and social settings.
Approval of Adderall XR is based on two clinical studies,
involving more than 600 pediatric subjects at over 50 sites.
Results from a laboratory classroom study showed that Adderall XR
provided longer-lasting symptom control than the original Adderall.
Adderall XR demonstrated statistically significant superiority in
symptom control over placebo at all times observed from 1.5 to 12
hours after dosing. Symptoms included hyperactivity, impulsivity
and the inability to work, focus and learn.
In a second clinical study, including more than 500 ADHD
diagnosed children, a morning administration of Adderall XR was
shown to provide as significant an improvement in attention and
behavior at 4 p.m. as was observed at 10 a.m.
Adverse events associated with the use of Adderall XR may
include (but are not limited to) the following:
- Anorexia
- Insomnia
- Abdominal pain
- Emotional lability
- Nervousness
Adderall XR is an amphetamine product that acts as a stimulant
to the central nervous system. It is unknown through which
mechanism amphetamines produce mental and behavioral effects in
children.
For additional information on attention deficit/hyperactivity
disorder, please visit ADHD.com.