Clinical Data in
Adult Patients
Take a whole-day view of ADHD
with a fast, lasting treatment
Improved attention vs placebo in adults, measured by mean PERMP-T scores averaged across all time points up to 16 hours post-dose.1,2*
PERMP-T=Permanent Product Measure of Performance Total. The PERMP is a validated, time-sensitive, skill-adjusted math test that measures attention in ADHD patients. It consists of simple math problems to be attempted and completed at multiple time points throughout a study.1
*Randomized, double-blind, placebo-controlled, crossover design, adult workplace environment (AWE) study in 45 adults (18-58 years) with ADHD.
Primary endpoint: Mean PERMP-T scores of Adhansia XR vs placebo, averaged across all time points on the AWE days.1,2
ADULT SYMPTOM STUDY
Symptom improvement evaluated in a fixed dose trial over 4 weeks1,3
STUDY DESIGN1,3
Description: A 4-week, randomized, double-blind, placebo-controlled trial with a fixed-dose design involving 375 adult patients (18-72 years) who met the DSM-5 criteria for ADHD.
Patients were randomized to one of five treatment arms with Adhansia XR 25, 45, 70, 100 mg, or placebo. Doses were titrated to the randomized, fixed dose over 2 weeks, then maintained at the assigned fixed dose for an additional 2 weeks. Note: 100 mg dose is not available.
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 PHASE1,3
PATIENT DEMOGRAPHICS4
*Combined=inattentive and hyperactive/impulsive.
PRIMARY ENDPOINT:
Improved ADHD symptoms in adults vs placebo1
Adhansia XR improved symptoms vs placebo, as measured by change in ADHD-5-RS total score from baseline (Visit 2, Week 1) to Visit 6, Week 51,4
Significant improvements were demonstrated at doses of 45 and 100 mg.
PRIMARY EFFICACY RESULTS1,4
The ADHD-5-RS is an 18-question, clinician-administered scale assessing ADHD symptoms and their severity based on the DSM-5 ADHD criteria.1,3
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
Although efficacy was demonstrated in short-term controlled trials in adults at dosages of 100 mg daily, dosages above 85 mg daily were associated with a disproportionate increase in the incidence of certain ARs.1
Discontinuation rates due to ARs in adult trial1: Adhansia XR 3% vs placebo 3%.
ARs OCCURRING IN ≥2% OF ADULT PATIENTS WITH ADHD ON
ADHANSIA XR AND GREATER THAN PATIENTS TAKING PLACEBO IN A 4-WEEK
CLINICAL TRIAL (STUDY 1, N=375)1
| ADVERSE REACTION | ADHANSIA XR | ADHANSIA XR ALL DOSES | PLACEBO | |||
|---|---|---|---|---|---|---|
| 25 mg (n=77) | 45 mg (n=73) | 70 mg (n=73) | 100 mg (n=74) | (n=297) | (n=78) | |
| Initial insomnia | 4% | 8% | 6% | 7% | 6% | 1% |
| Insomnia* | 17% | 11% | 16% | 19% | 16% | 4% |
| Dry mouth* | 8% | 8% | 7% | 14% | 9% | 4% |
| Nausea | 4% | 6% | 4% | 11% | 6% | 3% |
| Diarrhea | 1% | 3% | 7% | 5% | 4% | 1% |
| Decreased appetite* | 4% | 7% | 15% | 19% | 11% | 3% |
| Feeling jittery | 1% | 3% | 8% | 4% | 4% | 1% |
| Weight decreased | 3% | 4% | 3% | 5% | 4% | 1% |
| Upper respiratory tract infection | 0% | 4% | 3% | 3% | 2% | 1% |
ARs=adverse reactions.
*Most common (incidence ≥5% and at least twice placebo) adverse reactions of Adhansia XR occurring in controlled trials in adults.1
Note: Drugs known to have clinically important interactions with Adhansia XR are monoamine oxidase inhibitors, gastric pH modulators, antihypertensive drugs, and risperidone.1
Adult Onset & Duration Study (AWE)
STUDY DESIGN1,2
Description: A randomized, double-blind, placebo-controlled, crossover design,
adult workplace environment (AWE) study of Adhansia XR in 45 adults (18-58 years) who
met the DSM-5 criteria for ADHD.
STUDY TIMETABLE1,2
During the AWE sessions, efficacy was assessed at pre-dose and 1, 2, 5, 8, 11, 14, and 16 hours post-dose using the Permanent Product Measure of Performance Total (PERMP-T) score.1 Note: 100 mg dose is not available.
Primary endpoint: Comparison of Adhansia XR vs placebo mean PERMP-T scores, averaged across all time points on the AWE days.
Secondary endpoint: Onset and duration of clinical effect, as assessed by the treatment difference in PERMP-T scores at post-dose time points.
DSM-5=Diagnostic and Statistical Manual of Mental Disorders, 5th Edition; PERMP=skill-adjusted math test; PERMP-T=# of problems attempted + # of problems answered correctly.1,2
PATIENT DEMOGRAPHICS2,4
*Combined=inattentive and hyperactive/impulsive.
PRIMARY ENDPOINT:
Improved attention in adults to help them focus throughout their day1
Improved attention vs placebo in adults, measured by mean PERMP-T scores averaged across all time points up to 16 hours post-dose1,2*
Significantly improved post-dose LS mean PERMP-T scores averaged across all time points vs placebo.1*
PRE- AND POST-DOSE MEAN PERMP-T SCORES (N=45)1
N=number of subjects in the primary efficacy analysis set; LS=least squares; SD=standard deviation; SE=standard error; CI=95% confidence interval.
*Efficacy assessments were conducted at pre-dose and 1, 2, 5, 8, 11, 14, and 16 hours post-dose during the AWE sessions.1
†Difference (drug minus placebo) in LS mean of post-dose scores (95% CI 15.19, 38.41).1
SECONDARY ENDPOINT:
A fast, lasting treatment shown to improve attention in adults1,2
Improved attention at 1 hour and 16 hours vs placebo in adults, as measured by mean PERMP-T scores1,2,4*
Hour 14 was not statistically significant.
Improvements vs placebo were demonstrated at 1, 2, 5, 8, 11, and 16 hours post-dose.1,2,4*
LS MEAN PERMP-T SCORES OVER 16 HOURS (N=45)4
*Efficacy assessments were conducted pre-dose and at 1, 2, 5, 8, 11, 14, and 16 hours post-dose during the AWE sessions.1
†p<0.0001; ‡p=0.0028; §p=0.0018; ||p=0.0008; ns=not significant (p=0.0741).4
Most common adverse reactions
& discontinuation rates1
Although efficacy was demonstrated in short-term controlled trials in adults at dosages of 100 mg daily, dosages above 85 mg daily were associated with a disproportionate increase in the incidence of certain ARs.1
The most common ARs (incidence ≥5% and at least twice placebo) of Adhansia XR occurring in controlled trials in adults were insomnia, dry mouth, nausea, and decreased appetite.
Discontinuation rates due to ARs in an AWE study: Adhansia XR 10% vs placebo 0%.
The following ARs led to discontinuation at a frequency of 2% of Adhansia XR-treated patients: nausea, bronchitis, gastroenteritis viral, viral infection, blood pressure increased, and hypomania.
ARs=adverse reactions.
Note: Drugs known to have clinically important interactions with Adhansia XR are monoamine oxidase inhibitors, gastric pH modulators, antihypertensive drugs, and risperidone.1