Help bring your pediatric patients' whole day into focus with a fast, lasting treatment

Help bring your pediatric patients' whole
day into focus with a fast, lasting treatment

Improved ADHD symptoms vs placebo in children (6-12 years), measured by mean SKAMP-C scores averaged across all time points from 1-13 hours post-dose.1,2*†‡

SKAMP=Swanson, Kotkin, Agler, M-Flynn, and Pelham rating scale.1
*Randomized, double-blind, placebo-controlled, parallel group, analog classroom trial in children 6-12 years with ADHD (n=147).
Primary endpoint: Mean SKAMP-Combined scores, averaged across 8 time points on the analog classroom day.1,2
Efficacy evaluated pre-dose and 1, 2, 4, 8, 10, 12, and 13 hours post-dose on the analog classroom day.1,2
Symptoms of ADHD in a classroom setting.2

Onset & Duration Study in children with ADHD (ages 6-12)1,2

STUDY DESIGN1,2

Description: A randomized, double-blind, placebo-controlled, parallel group, analog classroom trial in 147 children (6-12 years) who met the DSM-5 criteria for ADHD. Adhansia XR doses were optimized over 6 weeks in the open-label phase (25 mg, 35 mg, 45 mg, 55 mg, 70 mg, or 85 mg, with a mean dose of 48 mg). Patients were then randomized for a 1-week, double-blind treatment phase.

STUDY DESIGN1,2

Adhansia Pediatric Study Design

Efficacy evaluated pre-dose and 1, 2, 4, 6, 8, 10, 12, and 13 hours post-dose using the SKAMP, a scale assessing symptoms of ADHD in a classroom setting.

Primary endpoint: Comparison of Adhansia XR vs placebo in mean SKAMP-C scores, averaged across 8 time points on the analog classroom day.

Secondary endpoints: Onset and duration of clinical effect of Adhansia XR vs placebo, as assessed by the treatment difference in SKAMP-C scores at post-dose time points.

DSM-5=Diagnostic and Statistical Manual of Mental Disorders, 5th Edition; SKAMP=Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale; SKAMP-C=SKAMP-Combined; the sum of scores on 13 items, each of which is rated on a 7-point impairment scale (0=none, 6=maximal impairment).

PATIENT DEMOGRAPHICS3

Study 1 pediatric demographics

*Combined=inattentive and hyperactive/impulsive.

PRIMARY ENDPOINT:

Improved children’s ADHD symptoms to help them focus throughout their day1

Improved ADHD symptoms vs placebo in children (6-12 years), measured by mean SKAMP-C scores averaged from 1-13 hours post-dose.1,2*

Significantly reduced post-dose LS mean SKAMP-C scores averaged across 8 time points vs placebo.1

PRE- AND POST-DOSE MEAN SKAMP-C SCORES (N=147)1

Pediatric OD Efficacy Primary

N=number of subjects in the primary efficacy analysis set; SD=standard deviation; SE=standard error; LS=least squares; CI=confidence interval, not adjusted for multiple comparisons; SKAMP=Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale; SKAMP-C=SKAMP-Combined; the sum of scores on 13 items, each of which is rated on a 7-point impairment scale (0=none, 6=maximal impairment).

*Symptoms of ADHD in a classroom setting.2

Efficacy assessments were conducted at pre-dose and 1, 2, 4, 6, 8, 10, 12, and 13 hours post-dose on the analog classroom day.1,2

Difference (drug minus placebo) in LS mean of post-dose scores (95% CI -10.6, -6.6).1

SECONDARY ENDPOINTS:

Symptom improvement demonstrated up to 13 hours1

Improved ADHD symptoms from 1-13 hours vs placebo in children (6-12 years), measured by mean SKAMP-C scores1,2*†‡

Improvements vs placebo demonstrated at all post-dose time points (1, 2, 4, 6, 8, 10, 12, and 13 hours).1,2

LS MEAN SKAMP-C SCORES OVER 13 HOURS (N=147)1,2

Study 2 secondary endpoint

LS=least squares (the raw mean is presented at the pre-dose time point, rather than the LS mean); SKAMP=Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale; SKAMP-C=SKAMP-Combined; the sum of scores on 13 items, each of which is rated on a 7-point impairment scale (0=none, 6=maximal impairment).

*Symptoms of ADHD in a classroom setting.2

Efficacy assessments were conducted at pre-dose and 1, 2, 4, 6, 8, 10, 12, and 13 hours post-dose on the analog classroom day.1,2

p<0.0001 for all time points.2

Most common adverse reactions
& discontinuation rates1

Discontinuation rates due to ARs: Adhansia XR 1% vs placebo 0%.

In short-term controlled trials in pediatric patients, efficacy was demonstrated at dosages of 70 mg daily, but dosages of ≥70 mg and higher were associated with a disproportionate increase in the incidence of certain adverse reactions.

ARs reported in >5% of patients during the open-label Adhansia XR treatment phase:

Decreased appetite (35%), upper abdominal pain (15%), affect lability (13%), nausea or vomiting (13%), weight decreased (12%), insomnia (10%), irritability (10%), headache (10%), and heart rate increased (5%).

Due to the trial design (6-week, open-label treatment phase, then a 1-week, randomized, double-blind, placebo-controlled withdrawal), the ARs in the double-blind phase were lower than expected in clinical practice.

There was no difference in the incidence of ARs between Adhansia XR and placebo during the 1-week, double-blind phase.

ARs=adverse reactions.

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