Demonstrated

Duration of Effect

Better attention as measured by PERMP1,2

Better Attention
for up to 16 hours

post-dose, measured from 2 hours, vs placebo in patients aged 13-17
as evaluated by PERMP1

Duration of Effect: Study 5

Primary Endpoint: Adolescent patients receiving Mydayis 25 mg demonstrated significant improvement in attention compared with placebo on PERMP total score measured from 2 hours and continuing up to 16 hours post-dose.1 The post-dose average score over all testing sessions was 256 for Mydayis and 215 for placebo (P<0.0001).2

PERMP Total Score by Post-Dose Time Points2

Improvement in attention in patients aged 13-17 up to 16 hours post-dose (measured from 2 hours)

PERMP Attention in ADHD was measured using the Permanent Product Measure of Performance (PERMP), which is a skill-adjusted math test. The PERMP score is the sum of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session. Higher scores indicate better attention.1,2

IMPORTANT SAFETY INFORMATION (continued)

Warnings and Precautions

  • Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmia, coronary artery disease, and other serious heart problems. Sudden death, stroke and myocardial infarction have been reported in adults with CNS stimulants at recommended doses, as well as sudden death in pediatric patients with structural cardiac abnormalities and other serious heart problems while taking CNS stimulants at recommended doses. Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias during Mydayis treatment.

Phase 2: Study Design1,2

Duration of Effect: Study 5

Duration of effect clinical Study 5 for Mydayis (mixed salts of a single-entity amphetamine product) study design

PRIMARY ENDPOINT: Efficacy of Mydayis compared with placebo determined by PERMP total score for the average of all post-dose assessments.


POPULATION

84 adolescents, aged 13-17, who met DSM-IV-TR® criteria for ADHD

DESIGN

Phase II randomized, double-blind, multicenter, placebo-controlled crossover study

ENVIRONMENT

Classroom-type setting for a 16-hour day

DSM-IV-TR®=Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision.

DSM-IV-TR is a registered trademark of the American Psychiatric Association.

References
  1. Mydayis [package insert]. Lexington, MA; Shire US Inc.
  2. Data on file; SPD465-202; Shire US Inc.