INDICATION AND LIMITATION OF USE

Vyvanse is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in patients ages 6 and above. Vyvanse is not indicated or recommended for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and effectiveness of Vyvanse for the treatment of obesity have not been established.

This site is intended for US healthcare professionals only.

IMPORTANT SAFETY INFORMATION

WARNING: ABUSE AND DEPENDENCE

  • CNS stimulants (amphetamines and methylphenidate-containing products), including Vyvanse, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy.
Full Safety Information Below

Vyvanse is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in patients ages 6 and above. Vyvanse is not indicated or recommended for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and effectiveness of Vyvanse for the treatment of obesity have not been established.

IMPORTANT SAFETY INFORMATION    This site is intended for US healthcare professionals only.

WARNING: ABUSE AND DEPENDENCE

  • | CNS stimulants (amphetamines and methylphenidate-containing products), including Vyvanse, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy.
Full Safety Information Below

316 Study: Efficacy Assessments Using PERMP

Explore the clinical study design of Vyvanse as a treatment for adult patients with ADHD Vyvanse demonstrated a statistically significant improvement in attention in adults with ADHD¹

  • Multicenter, randomized, double-blind, placebo-controlled, crossover, modified analog classroom study to simulate a workplace environment in 142 adults aged 18-55 years with ADHD (as defined by DSM-IV-TR®).1,2
  • During a 4-week open-label, dose optimization phase, subjects were titrated to an optimal dose of Vyvanse 30, 50, or 70 mg/day in the morning. They were then randomized in the double-blind crossover phase to receive Vyvanse (optimized dose) followed by placebo or placebo followed by Vyvanse, each for 1 week. During the double-blind phase, efficacy assessments occurred at the end of each week using PERMP.1,2
  • PERMP is an objective, validated, skill-adjusted math test that measures attention in ADHD. The PERMP total score comprises the sum of the number of math problems attempted and the number of math problems answered correctly. Higher scores indicate less severe symptoms. PERMP is not a test of the ability to learn math1,2
  • Primary Endpoint: Average of the PERMP total scores from all postdose sessions measured from 2 to 14 hours2
  • Key Secondary Endpoint: Duration of efficacy as measured by PERMP total score at 2, 4, 8, 10, 12, and 14 hours postdose2
  • DSM-IV-TR®=Diagnostic and Statistical Manual of Mental Disorders, 4th ed, text revision.
  • PERMP=Permanent Product Measure of Performance.
STUDY FLOW1,2

PATIENT CHARACTERISTICS3

In a study of 142 patients aged 18-55 years, the following were diagnosed with ADHD:

STUDY ENVIRONMENT

Schedule of activities and PERMP administration across the day at select timepoints (Weeks 5 and 6)2,3

  • Consisted of structured activities intended to provoke symptoms of ADHD
  • Structured activities were administered prior to PERMP assessments; however, subjects were not evaluated on the structured activities
  • *Session work consisted of a 5-minute transition time, a 10-minute math test (PERMP), and a 10-minute group activity.

Adults with ADHD taking Vyvanse had a significantly higher LS (least squares) mean PERMP total score across all postdose assessments measured from 2 to 14 hours compared with adults taking placebo.1-4

PRIMARY ENDPOINT: Average of PERMP total scores from all postdose sessions1,3,4

Vyvanse demonstrated a statistically significant improvement in attention in adults with ADHD

LS Mean PERMP Total Score3,4
(Sum of number of math problems attempted and number answered correctly)

  • n=104.
  • LS=least-squares.
  • *P<.0001 for Vyvanse vs placebo.
  • Difference in LS mean PERMP total score.
  • Average of all doses tested.

IMPORTANT SAFETY INFORMATION (cont’d)

  • Contraindications
    Patients should not take Vyvanse if they are:
    • hypersensitive to amphetamines or other ingredients of Vyvanse. Anaphylactic reactions, Stevens-Johnson Syndrome, angioedema, and urticaria have occurred.
    • taking monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping MAOIs (including MAOIs such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis.
KEY SECONDARY ENDPOINT: Duration of efficacy as measured by PERMP total scores at 2, 4, 8, 10, 12, and 14 hours postdose1-4

Vyvanse demonstrated consistent efficacy at each timepoint measured from 2 to 14 hours postdose

PERMP Total Score (LS Mean) by Postdose Timepoint3,4

  • n=104.
  • LS=least squares.
  • *Average of all doses tested.
  • At 2-hour timepoint: P=.0017 for Vyvanse vs placebo.
  • At all other postdose timepoints assessed: P<.0001 for Vyvanse vs placebo.

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