Vyvanse (Lisdexamfetamine Dimesylate)
Company: New River
Approval Status: Approved February 2007
Treatment for: Attention-Deficit/Hyperactivity Disorder
Areas: Neurology; Pediatrics/Neonatology; Psychiatry/Psychology
| General Information | Clinical Results | Side Effects | Mechanism of Action | Literature References | Additional Information |
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.
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.
