PEDIATRIC STUDIES

Efficacy in Children

STUDY 301

EFFICACY IN ADHD (6-12 YEARS)

How symptom control was evaluated in children (6-12 years)

Safety and efficacy of Vyvanse 30, 50, and 70 mg/day were compared with placebo in a randomized, double-blind, parallel-group, placebo-controlled, 4-week study with forced-dose titration.1,2

Primary Endpoint: Change from baseline to endpoint* in ADHD-RS-IV total score1,2

Secondary Endpoint: Duration of efficacy as measured by CPRS ADHD index at 10 AM, 2 PM, and 6 PM1,2

*Last postrandomization treatment week for which a valid ADHD-RS-IV total score was obtained.

ADHD-RS-IV=Attention-Deficit/Hyperactivity Disorder Rating Scale, Version IV, a validated, investigator-rated measure that consists of 18 items designed to reflect the symptomatology of ADHD based on DSM-IV-TR® criteria.

CPRS=Conners’ Parent Rating Scale, an instrument that uses parent ratings to help assess ADHD symptoms and behaviors in children. In this study, parents rated their child’s symptomatic behaviors at 10 AM, 2 PM, and 6 PM.

DSM-IV-TR®=Diagnostic and Statistical Manual of Mental Disorders, 4th ed, text revision.

Efficacy assessed in patients aged 6-12 years using ADHD-RS-IV and CPRS ADHD Index

Vyvanse demonstrated a significant reduction in ADHD-RS-IV total score.1,2

Vyvanse provided a 56% average reduction in ADHD-RS-IV total score (from 43.9 to 19.5) for all doses combined vs a 14% average reduction for placebo (from 42.4 to 36.6)†1-3

Mean change from baseline in ADHD-RS-IV total score at endpoint1-3

P<.0001 for Vyvanse vs placebo.
§Average of all doses tested.

Children aged 6-12 treated with Vyvanse experienced significant symptom improvement based on CPRS at 10:00 AM, 2:00 PM, and 6:00 PM vs placebo.1,2

LS Mean Percentage Change From Baseline to Endpoint on CPRS ADHD Index4–6

P<.0001 for Vyvanse vs placebo at all timepoints measured.
§Average of all doses tested. Median daily dosing between 7:30 AM  and 8 AM.
LS=least squares

STUDY 305

EFFICACY IN ADHD (13-17 YEARS)

How symptom control was evaluated in adolescents (13-17 years)

Safety and efficacy of Vyvanse 30, 50, and 70 mg/day were compared with placebo in a randomized, double-blind, parallel-group placebo-controlled, 4-week study with forced-dose titration.1,2

Primary Endpoint: Change from baseline to endpoint* in ADHD-RS-IV total score1,2

*Last postrandomization treatment week for which a valid ADHD-RS-IV total score was obtained.

ADHD-RS-IV=Attention-Deficit/Hyperactivity Disorder Rating Scale, Version IV, a validated investigator-rated measure that consists of 18 items designed to reflect symptomatology of ADHD based on DSM-IV-TR® criteria.

DSM-IV-TR®=Diagnostic and Statistical Manual of Mental Disorders,  4th ed, text revision.

Efficacy assessed in patients aged 13-17 years using ADHD-RS-IV

Vyvanse demonstrated a significant reduction in ADHD-RS-IV total score1,2

Mean Change in ADHD-RS-IV total score from baseline to endpoint1,3

P<.0001 for Vyvanse vs placebo at endpoint.
Average of all doses tested.

STUDY 311

DURATION OF EFFICACY (6-12 years)

How efficacy throughout the day was evaluated in children (6-12 years)

Duration of efficacy of Vyvanse was assessed in a randomized, double-blind, placebo-controlled, crossover, analog classroom study.1,2

During a 4-week, open-label, dose-optimization phase, subjects were titrated to an optimal dose of Vyvanse 30 mg, 50 mg, or 70 mg/day in the morning. They were randomized in the double-blind crossover phase to receive Vyvanse (optimized dose) followed by placebo, or placebo followed by Vyvanse, each for 1 week of treatment. During the double-blind phase, efficacy assessments occurred at the end of each week in the analog classroom setting using the SKAMP-D subscale.1,2

Primary Endpoint:  Time of onset of Vyvanse compared with placebo in the analog classroom setting, as measured by average SKAMP-D subscale scores2

Key Secondary Endpoint:  Duration of efficacy of Vyvanse compared with placebo in the analog classroom setting, as measured by average SKAMP-D subscale scores evaluated at 1.5, 2.5, 5, 7.5, 10, 12, and 13 hours postdose2

DSM-IV-TR®=Diagnostic and Statistical Manual of Mental Disorders, 4th ed, text revision.

SKAMP-D (Swanson, Kotkin, Agler, M-Flynn, and Pelham Deportment) subscale is a validated, standardized classroom assessment tool that measures behavior problems leading to classroom disruptions. It is not a measure of classroom or academic performance. Lower scores indicate less severe symptoms.2

Duration of efficacy was not systematically evaluated in patients aged 13-17.

Vyvanse demonstrated consistent behavior improvement at each postdose timepoint measured for children aged 6-12 with ADHD.1,2

Significant improvement in behavior at 1.5 hours postdose based on SKAMP-D1,2

Primary Endpoint: At 1.5 hours postdose, SKAMP-D score of .70 for Vyvanse vs 1.14 for placebo (P<.005)1,2

Children aged 6-12 with ADHD treated with Vyvanse, experienced a statistically significant improvement in their SKAMP-D score throughout the day at every timepoint measured, up to 13 hours postdose vs placebo.1,2

LS Mean SKAMP-D Score by Postdose Timepoint1-3

n=113
Average of all doses tested.
P<.0001 for Vyvanse vs placebo at endpoint.
LS=least squares.

STUDY 326

MAINTENANCE OF EFFICACY IN ADHD (6-17 YEARS)

How maintenance of efficacy in ADHD was evaluated in children (6-17 years)

Maintenance of symptom control with Vyvanse was assessed in a multicenter, double-blind, placebo-controlled, randomized withdrawal study. Patients were treated with open-label Vyvanse 30, 50, or 70 mg/day for at least 26 weeks prior to being assessed for entry into the 6-week, double-blind, randomized withdrawal phase. Eligible patients had to demonstrate treatment response as defined by ADHD-RS-IV total score ≤22 and CGI-S ≤2.1,2

Primary Endpoint: The proportion of patients with treatment failure (relapse) during the 6-week, randomized withdrawal phase. Treatment failure (relapse) was defined as ≥50% increase (worsening) in ADHD-RS-IV total score and a ≥2-point increase in CGI-S score compared to scores at entry of the randomized withdrawal phase. Patients who met treatment failure criteria were immediately withdrawn from the study.1,2

DSM-IV-TR®=Diagnostic and Statistical Manual of Mental Disorders, 4th ed, text revision.

ADHD-RS-IV=Attention-Deficit/Hyperactivity Disorder Rating Scale, Version IV, a validated, investigator-rated measure that consists of 18 items designed to reflect the symptomatology of ADHD based on DSM-IV-TR® criteria.

CGI-S=Clinical Global Impression Severity, a scale which assesses the clinician's impression of the patient's current illness state and ranges from 1 (not at all ill) to 7 (extremely ill).

Vyvanse maintained symptom control in this long-term study1,2

A significantly lower proportion of treatment failures occurred among those children taking Vyvanse (15.8%) compared to placebo (67.5%) at endpoint* of the randomized withdrawal phase1,2

Percentage of Children who Maintained ADHD Symptom Control at Endpoint*1,2

*The endpoint measurement was defined as the last post-randomization treatment week at which a valid ADHD-RS-IV total score and CGI-S score were observed.

Periodically re-evaluate patients for the continued need for Vyvanse.


Get to know your pediatric patients and their administration options.

Hypothetical patient portrayal.
Individual results may vary.

ONCE-DAILY DOSING AND CUSTOMIZABLE ADMINISTRATION

Only Vyvanse (lisdexamfetamine dimesylate) has 5 administration options, so you can tailor treatment to meet the needs of each pediatric ADHD patient (ages 6-17).

Help your eligible patients start saving.

Hypothetical patient portrayal

SHOW YOUR ELIGIBLE PATIENTS HOW THEY COULD SAVE

You’re dedicated to your patients. We’re dedicated to providing a savings offer to help make Vyvanse prescriptions accessible to them. See details. Restrictions apply.

References
  1. Vyvanse [package insert]. Lexington, MA: Shire US Inc.
  2. Biederman J, Krishnan S, Zhang Y, McGough JJ, Findling RL. Efficacy and tolerability of lisdexamfetamine dimesylate (NRP-104) in children with attention-deficit/hyperactivity disorder: a phase III, multicenter, randomized, double-blind, forced-dose, parallel-group study. Clin Ther. 2007;29(3):450-463.
  3. Data on file; LDX006; Shire US Inc.
  4. Lopez FA, Ginsberg LD, Arnold V. Effect of lisdexamfetamine dimesylate on parent-rated measures in children aged 6 to 12 years with attention-deficit/hyperactivity disorder: a secondary analysis. Postgrad Med. 2008;120(3):89-102.
  5. Data on file; LDX010; Shire US Inc.
  6. Data on file; NRP104-099; Shire US Inc.
References
  1. Vyvanse [package insert]. Lexington, MA: Shire US Inc.
  2. Findling RL, Childress AC, Cutler AJ, et al. Efficacy and safety of lisdexamfetamine dimesylate in adolescents with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2011;50(4):395-405.
  3. Data on file; LDX079; Shire US Inc.
References
  1. Vyvanse [package insert]. Lexington, MA: Shire US Inc.
  2. Wigal SB, Kollins SH, Childress AC, Squires L; 311 Study Group. A 13-hour laboratory school study of lisdexamfetamine dimesylate in school-aged children with attention-deficit/hyperactivity disorder. Child Adolesc Psychiatry Ment Health. 2009;3(1):17.
  3. Data on file; LDX079; Shire US Inc.
References
  1. Vyvanse [package insert]. Lexington, MA: Shire US Inc.
  2. Coghill DR, Banaschewski T, Lecendreux M, et al. Maintenance of efficacy of lisdexamfetamine dimesylate in children and adolescents with attention-deficit/hyperactivity disorder: randomized-withdrawal study design. J Am Acad Child Adolesc Psychiatry. 2014;53(6):647-657.e1.

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