Clinical Data in
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For your patients who require an extended‑release methylphenidate product, Adhansia XR significantly improved ADHD symptoms vs placebo 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
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.
*Combined=inattentive and hyperactive/impulsive.
Improved ADHD symptoms in adolescents (12-17 years) vs placebo1
Adhansia XR improved symptoms in adolescents (12-17 years) vs placebo, measured by 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 |
|Abdominal pain upper||5%||1%||5%||4%||4%||1%|
*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, and risperidone.1