ADULT STUDIES

Efficacy in Adults

ADULT EFFICACY &
SAFETY DATA

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STUDY 316

ATTENTION IN ADHD

How efficacy throughout the day was evaluated

Duration of efficacy of Vyvanse was assessed in a multicenter, randomized, double-blind, placebo-controlled, crossover, modified analog classroom study to simulate a workplace environment.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

Primary Endpoint: Average of the PERMP total scores from all postdose sessions measured, from 2 to 14 hours1,2

Key Secondary Endpoint: Duration of efficacy as measured by PERMP total score at 2, 4, 8, 10, 12, and 14 hours postdose1,2

DSM-IV-TR®=Diagnostic and Statistical Manual of Mental Disorders, 4th ed, text revision.
*PERMP=Permanent Product Measure of Performance, 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 math.1,2
ADHD-RS-IV=Attention-Deficit/Hyperactivity Disorder Rating Scale, Version IV.

Vyvanse demonstrated consistent efficacy throughout the day

Statistically significant improvement in attention was seen at each timepoint measured, from 2 to 14 hours postdose.1,3

Primary Endpoint: Adults with ADHD taking Vyvanse had a least squares (LS) mean PERMP total score across all postdose assessments (from 2 to 14 hours) of 312.9 vs 289.5 for adults taking placebo, with a difference of 23.4 (P<.0001). Predose scores were: Vyvanse=260; placebo=263.2.*1,3,4

PERMP Total Score (LS Mean) by Postdose Timepoint1,3,4

n=104.

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.

STUDY 303

EFFICACY

How symptom control was evaluated

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 in ADHD-RS-IV* total score at endpoint†1

*ADHD-RS-IV=Attention-Deficit/Hyperactivity Disorder Rating Scale, Version IV, with Adult Prompts, an investigator-rated measure of the core symptoms of ADHD.
Endpoint was defined as the last post-randomization treatment week for which a valid score was obtained

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

Vyvanse significantly improved ADHD symptoms in adults1

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

2X

greater improvement with Vyvanse vs placebo

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

STUDY 401

MAINTENANCE OF EFFICACY

How maintenance of ADHD symptom control was evaluated

Maintenance of symptom control with Vyvanse (lisdexamfetamine dimesylate) was assessed in a Phase 4, multicenter, double-blind, placebo-controlled, randomized withdrawal study.1,2

Efficacy was assessed based on the ADHD-RS-IV with adult prompts and CGI-S at study entry (baseline), and weekly thereafter during the open-label and randomized withdrawal phases.2

Primary Endpoint: The proportion of patients with treatment failure (relapse) during the 6-week, randomized withdrawal phase. Treatment failure 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 the relapse 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, an investigator-rated measure of the core symptoms of ADHD.
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 a long-term study1,2

ADHD Symptom Control Maintained* 1,2

*At the end of the 6-week, randomized withdrawal phase.

Periodically reevaluate patients for the continued need for Vyvanse.


Get to know your patients dosing options.

Hypothetical patient portrayal.
Individual results may vary.

ONCE-DAILY DOSING AND CUSTOMIZABLE ADMINISTRATION

Vyvanse has once-daily dosing and only Vyvanse (lisdexamfetamine dimesylate) has 5 administration options, so you can tailor treatment to meet the needs of your patients with ADHD.1

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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. Wigal T, Brams M, Gasior M, et al; 316 Study Group. Randomized, double-blind, placebo-controlled, crossover study of the efficacy and safety of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder: novel findings using a simulated adult workplace environment design. Behav Brain Funct. 2010;6:34.
  3. Data on file; SPD489-066; Shire US Inc.
  4. Data on file; SPD489-067; Shire US Inc.
References
  1. Vyvanse [package insert]. Lexington, MA: Shire US Inc.
  2. Adler L, Goodman D, Kollins S, et al; 303 Study Group. Double-blind, placebo-controlled study of the efficacy and safety of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder. J Clin Psychiatry. 2008;69(9):1364-1373. 
  3. Data on file; LDX085; Shire US Inc. 
References
  1. Vyvanse [package insert]. Lexington, MA: Shire US Inc.
  2. Brams M, Weisler R, Findling RL, et al. Maintenance of efficacy of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder: randomized withdrawal design. J Clin Psychiatry. 2012;73(7):977-983. 

INDICATION AND IMPORTANT SAFETY INFORMATION