Adderall XR
Company: Shire Pharmaceuticals
Approval Status: Approved October 2001
Treatment for: Attention deficit/hyperactivity disorder (ADHD)
Areas: Pediatrics/Neonatology; Psychiatry/Psychology
Possible similar drugs: Adderall
| General Information | Clinical Results | Side Effects | Mechanism of Action | Additional Information |
General Information
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.
Clinical Results
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.
Side Effects
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
Mechanism of Action
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.
Additional Information
For additional information on attention deficit/hyperactivity disorder, please visit ADHD.com.
The FDA drug information shown here is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.
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