General Information

Vyvanse is a pro-drug of dextroamphetamine. It works primarily by inducing the release of the neurotransmitters dopamine and norepinephrine from their storage areas in nerve terminals. Both of these transmitters contribute to maintaining alertness, increasing focus and sustaining thought, effort and motivation.

Vyvanse is specifically indicated for the treatment of attention deficit/hyperactivity disorder (ADHD) in pediatric populations ages 6 to 12 years.

Mechanism of Action

Vyvanse is a pro-drug of dextroamphetamine. Amphetamines are thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space. Norepinephrine and dopamine contribute to maintaining alertness, increasing focus and sustaining thought, effort and motivation. However, the exact therapeutic action in ADHD is not known.

Side Effects

Adverse events associated with the use of Vyvanse may include, but are not limited to, the following:

• Decreased appetite
• Insomnia
• Upper abdominal pain
• Headache
• Irritability
• Vomiting
• Decreased weight
• Nausea
• Dry mouth

Vyvanse is classified as a Schedule II controlled substance due to the potential for abuse and dependence.

Dosing/Administration

Vyvanse is supplied in 30 mg, 50 mg or 70 mg oral capsules designed for once daily oral administration. The recommended initial dose of the drug for this population is 30 mg once daily in the morning. This dose may be escalated beyond 30 mg/day by adjusting in increments of 20 mg/day and at approximately weekly intervals. The maximum recommended dose is 70 mg/day.

Clinical Trial Results

FDA Approval
FDA approval of Vyvanse was based on the results of two clinical trials.

Trial 1
This double-blind, randomized, placebo-controlled, parallel-group trial enrolled 290 children, ages 6 to 12, who met the Diagnostic and Statistical Manual of Mental Disorders, 4^th ed. (DSM-IV) criteria for ADHD. The subjects were placed into fixed-dose treatment groups and received final doses of 30, 50 or 70 mg of Vyvanse or placebo once daily in the morning for four weeks. Significant improvement in behavior, as measured by the ADHD Rating Scale, was the primary end point. This was achieved for all Vyvanse treatment groups when compared to placebo. These effects were maintained throughout the day based on parents’ rating (Connor’s Parent Rating Scale).

Trial 2
This double-blind, placebo-controlled, randomized, crossover design trial enrolled 52 children, ages 6 to 12, who met the DSM-IV criteria for ADHD. Following a three-week open-label dose titration with Adderall XR, subjects were randomly assigned to continue the same dose of Adderall XR (10, 20 or 30 mg), Vyvanse (30, 50 and 70 mg), or placebo once daily in the morning for one week each treatment. Based upon the average of investigator ratings on the Swanson, Kotkin, Agler, M.Flynn and Pelham (SKAMP)-Deportment scores across the eight sessions of a 12-hour treatment day, a significant improvement in behavior was observed in all the Vyvanse groups when compared to placebo.