Significant

Symptom Reduction

Demonstrated improvement in ADHD symptoms vs placebo
as measured by ADHD-RS-IV total score1-3

Improved efficacy VS PLACEBO1-3

Dose Optimization: Study 4

Primary Endpoint: Change from baseline in mean ADHD Rating Scale-IV (ADHD-RS-IV) total score at Week 4.1-3

ADHD-RS-IV Change at Endpoint (Full Analysis Set)1,3

Significant symptom reduction with Mydayis vs placebo

ADHD-RS-IV is an 18-item scale that was developed to measure the behaviors of children and adolescents with ADHD. Symptom severity is rated on a four-point scale, ranging from 0 (none) to 3 (severe).4

IMPORTANT SAFETY INFORMATION (continued)

Warnings and Precautions (continued)

  • CNS stimulants cause increased blood pressure (mean increase ~2-4 mm Hg) and heart rate (mean increase ~3-6 bpm). Monitor for tachycardia and hypertension.
  • Exacerbation of Pre-existing Psychosis : May exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder. Induction of a Manic Episode in Patients with Bipolar Disorder : May induce a mixed/manic episode in patients with bipolar disorder. Prior to initiating treatment, screen for risk factors for developing a manic episode (e.g., comorbid or history of depressive symptoms, or a family history of suicide, bipolar disorder, and depression). New Psychotic or Manic Symptoms : At recommended doses, may cause psychotic or manic symptoms (e.g., hallucinations, delusional thinking, or mania) in patients with no prior history of psychotic illness or mania. Discontinue if symptoms occur.

Dose Optimization: Study 41-3

PRIMARY ENDPOINT: Change from baseline in ADHD Rating Scale-IV (ADHD-RS-IV) Total Score at Week 4.


During the two-week dose optimization, all patients randomized to Mydayis initiated treatment at a dose of 12.5 mg. Patients were titrated to 25 mg of Mydayis based on symptom response and tolerability, at the week 1 visit.2

POPULATION

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

DESIGN

Phase III, randomized, double-blind, multicenter, placebo-controlled, dose-optimization study

The optimal dose was 25 mg for 82% of the adolescent patients in Study 4.

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. Childress A, Yu M, Yan B, Robertson B. A randomized, placebo-controlled study of the efficacy and safety of SHP465 mixed amphetamine salts extended-release in children and adolescents with ADHD: exploratory analyses by age group. Poster presented at: APSARD Annual Meeting; January 12-14, 2018; Washington DC.
  3. Data on file; SPD465-305; Shire US Inc.
  4. Brams M, Childress AC, Greenbaum M, et al. SHP465 mixed amphetamine salts in the treatment of attention-deficit/hyperactivity disorder in children and adolescents: results of a randomized, double-blind placebo-controlled study. J Child Adolesc Psychopharmacol. 2017. doi: 10.1089/cap.2017.0053.