Clinical Data in
Adolescent Patients
Help bring your patients'
day into focus
For your patients who require an extended‑release methylphenidate product, Adhansia XR significantly improved ADHD symptoms in patients 12‑17 years.1*
*4-week, randomized, double-blind, multicenter, placebo-controlled, safety and efficacy study in 354 adolescent patients (12-17 years) with ADHD.
Primary endpoint: Change in the adolescent ADHD-5-Rating Scale total score from baseline (Visit 2, Week 1) to Visit 6, Week 5. Adhansia XR demonstrated a statistically significant treatment effect compared to placebo at Visit 6, Week 5 for the 45 and 70 mg dose groups.1,2
ADOLESCENT SYMPTOM STUDY
Symptom improvement evaluated in a fixed-dose trial over 4 weeks1
STUDY DESIGN1,2
Description: A 4-week, randomized, double-blind, placebo-controlled trial with a fixed-dosed design, involving 354 adolescent patients (12-17 years) who met the DSM-5 criteria for ADHD.
Patients were randomized to one of five treatment arms with Adhansia XR 25, 45, 70, 85 mg, or placebo. Doses were titrated to a fixed dose over 2 weeks, then maintained at the fixed dose for an additional 2 weeks.
Primary endpoint: Change from baseline (Visit 2, Week 1) ADHD-5-RS total score at the end of the final evaluation visit (Visit 6, Week 5) vs placebo.
ADHD-5-RS=ADHD Rating Scale 5; DSM-5=Diagnostic and Statistical Manual of Mental Disorders, 5th Edition.
DOUBLE-BLIND PHASE2
PATIENT DEMOGRAPHICS2
*Combined=inattentive and hyperactive/impulsive.
PRIMARY ENDPOINT:
Improved ADHD symptoms in adolescents (12-17 years) vs placebo1
Adhansia XR improved symptoms in adolescents (12-17 years) vs placebo, measured by the change in ADHD-5-RS total score from baseline (Visit 2, Week 1) to Week 5 (Visit 6)1,2
Significant improvements were seen at doses of 45 and 70 mg.
PRIMARY EFFICACY RESULTS1,2
The ADHD-5-RS is an 18-question, clinician-administered scale assessing ADHD inattention and hyperactivity-impulsivity symptoms and their severity based on the DSM-5 ADHD criteria.1,2
n=number of subjects in the primary efficacy analysis set; LS=least squares; SE=standard error; CI=95% confidence interval, not adjusted for multiple comparisons.
*Statistically significantly different from placebo after adjusting for multiplicity.1
†Difference (drug minus placebo) in LS mean change from baseline.1
Most common adverse reactions
& discontinuation rates1
In short-term controlled trials in adolescent patients, efficacy was demonstrated at dosages of 70 mg daily, but dosages ≥70 mg daily were associated with a disproportionate increase in the incidence of certain ARs.1
Discontinuation rates due to ARs in the adolescent trial (12-17 years)1: Adhansia XR 3% vs placebo 0%.
The most frequent ARs leading to discontinuation in ≥1% of those taking Adhansia XR and at a rate greater than placebo was irritability (1%). Two patients taking Adhansia XR 70 or 85 mg had delirium leading to discontinuation.
ARs OCCURRING IN ≥2% OF ADOLESCENT PATIENTS (12-17 YEARS)
WITH ADHD TAKING ADHANSIA XR AND GREATER THAN PLACEBO IN A 4-WEEK
CLINICAL TRIAL (N=367)1
| ADVERSE REACTION | ADHANSIA XR | ADHANSIA XR ALL DOSES | PLACEBO | |||
|---|---|---|---|---|---|---|
| 25 mg (n=73) | 45 mg (n=72) | 70 mg (N=76) | 85 mg (n=72) | (n=293) | (n=74) | |
| Decreased appetite* | 7% | 19% | 28% | 26% | 20% | 0% |
| Insomnia* | 4% | 0% | 9% | 13% | 6% | 1% |
| Initial insomnia | 4% | 7% | 5% | 4% | 5% | 1% |
| Weight decreased* | 1% | 3% | 8% | 13% | 7% | 0% |
| Abdominal pain upper | 5% | 1% | 5% | 4% | 4% | 1% |
| Nausea | 3% | 6% | 7% | 8% | 6% | 4% |
| Dizziness | 3% | 0% | 4% | 4% | 3% | 0% |
| Dry mouth | 1% | 0% | 5% | 4% | 3% | 1% |
| Vomiting | 1% | 1% | 3% | 6% | 3% | 0% |
ARs=adverse reactions.
*Most common (incidence ≥5% and at least twice placebo) adverse reactions reported in adolescent patients (12-17 years).1
Note: Drugs known to have clinically important interactions with Adhansia XR are monoamine oxidase inhibitors, gastric pH modulators, antihypertensive drugs, halogenated anesthetics, and risperidone.1