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Home » Drug Information » FDA Approved Drugs » 2007
Medical Areas: Neurology | Pediatrics/Neonatology | Psychiatry/Psychology | Family Medicine

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Vyvanse (Lisdexamfetamine Dimesylate)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: New River
Approval Status: Approved February 2007
Treatment Area: Attention-Deficit/Hyperactivity Disorder

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 in pediatric populations aged 6 to 12 years.

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 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 6-12, who met the 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 endpoint. 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 6-12, who met the DSM-IV criteria for ADHD. Following a 3-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 1 week each treatment. Based upon the average of investigator ratings on the Swanson, Kotkin, Agler, M.Flynn and Pelham (SKAMP)-Deportment scores across the 8 sessions of a 12 hour treatment day, a significant improvement in behavior was observed in all the Vyvanse groups when compared to placebo.

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.

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.

Literature References

Spencer TJ, Wilens TE, Biederman J, Weisler RH, Read SC, Pratt R Efficacy and safety of mixed amphetamine salts extended release (Adderall XR) in the management of attention-deficit/hyperactivity disorder in adolescent patients: a 4-week, randomized, double-blind, placebo-controlled, parallel-group study. Clinical therapeutics 2006 Feb;28(2):266-79.

Ambrosini PJ, Sallee FR, Lopez FA, Shi L, Michaels MA; LADD.CAT Study Group A community assessment, open-label study of the safety, tolerability, and effectiveness of mixed amphetamine salts extended release in school-age children with ADHD. Current medical research and opinion 2006 Feb;22(2):427-40.

Kramer WG, Read SC, Tran BV, Zhang Y, Tulloch SJ Pharmacokinetics of mixed amphetamine salts extended release in adolescents with ADHD. CNS spectrums 2005 Oct;10(10 Suppl 15):6-13.

Gillberg C, Melander H, von Knorring AL, Janols LO, Thernlund G, Hagglof B, Eidevall-Wallin L, Gustafsson P, Kopp S Long-term stimulant treatment of children with attention-deficit hyperactivity disorder symptoms. A randomized, double-blind, placebo-controlled trial. Archives of general psychiatry 2001 Dec;58(12):1184.

Additional Information

For additional information regarding Vyvanse or Attention Deficit/Hyperactivity Disorder, please visit the Vyvanse web page.