Demonstrated

Duration of Effect

Patients demonstrated better attention up to 16 hours post-dose (measured from 2 or 4 hours) as evaluated by PERMP1-3

Significant Improvement

in attention up to 16 hours post-dose (measured from 2 or 4 hours)1-3

Duration of Effect: Study 2

Primary Endpoint: In a prespecified supplementary analysis, adult patients receiving Mydayis 50 mg demonstrated significant improvement in attention vs placebo on PERMP total score measured from 2 to 16 hours post-dose. The post-dose average score over all testing sessions was 285 for Mydayis and 262 for placebo (P <0.0001).1,2

PERMP Total Score by Post-Dose Time Points (50 mg)

Improvement in attention up to 16 hours post-dose (measured from 2 or 4 hours)
  • In the separate Study 3, adult patients who took Mydayis 25 mg experienced significantly greater improvement in attention from hours 4-16 post-dose compared with placebo on PERMP total score. The post-dose average score over all testing sessions was 268 for Mydayis and 249 for placebo (P <0.0001).1,3

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.1-3

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 Designs

  • Study 2
  • Study 3

Duration of Effect: Study 2

Duration of effect clinical Study 2 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.1,2

POPULATION

86 adults, aged 18-55, who met DSM-IV-TR® criteria for ADHD

DESIGN

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

ENVIRONMENT

Adult workplace laboratory environment adapted for a 16-hour adult day

Duration of Effect: Study 3

Duration of effect clinical Study 3 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.1,3

POPULATION

79 adults, aged 18-55, who met DSM-IV-TR® criteria for ADHD

DESIGN

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

ENVIRONMENT

Adult workplace laboratory environment adapted for a 16-hour adult 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; SPD465-201; Shire US Inc.
  3. Data on file; SPD465-203; Shire US Inc.