This site is intended for US healthcare professionals only
This site is intended for US healthcare professionals only
This site is intended for US healthcare professionals only
This site is intended for US healthcare professionals only
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.
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
†P<.0001 for Vyvanse vs placebo.
§Average of all doses tested.
‡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
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.
†P<.0001 for Vyvanse vs placebo at endpoint.
‡Average of all doses tested.
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.
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
n=113
*Average of all doses tested.
†P<.005 for Vyvanse vs placebo at all postdose timepoints assessed.
LS=least squares.
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).
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
*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.
Hypothetical patient portrayal.
Individual results may vary.
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).
Hypothetical patient portrayal
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.
VYVANSE and the VYVANSE logo are registered trademarks of Takeda Pharmaceuticals U.S.A., Inc. TAKEDA and the TAKEDA logo are registered trademarks of Takeda Pharmaceutical Company Limited. ©2022 Takeda Pharmaceuticals U.S.A., Inc. All rights reserved. 1-877-TAKEDA-7 (1-877-825-3327).
All content of this website, including text, images, graphics, sound files, and their arrangement, is copyrighted and owned by Takeda Pharmaceuticals U.S.A., Inc. and is protected by international copyright laws. All other intellectual property rights are reserved. The content may not be copied for commercial use or, distribution, nor may these objects be downloaded, modified, or posted to other sites. This site is intended solely for US residents and is governed solely by US laws and government regulations. Please see our Terms of Use for more information. While Takeda makes reasonable efforts to include accurate, up-to-date information on this site, Takeda makes no warranties or representations as to its accuracy. Takeda assumes no liability for any errors or omissions in the content of this site. The information on this site is not intended to make a diagnosis or to take the place of talking to a US healthcare professional.
US-LIS-1285v1.0 10/22