Proven Efficacy

Quillivant XR significantly improved attention and behavior at 45 minutes to 12 hours post-dosing vs placebo*

45 Minutes

Quillivant XR was effective at 45 minutes vs placebo; P<0.0001, as measured by SKAMP1

4 Hours

The primary efficacy endpoint as measured by SKAMP-Combined score at 4 hours; P<0.00011

12 Hours

Improvement in the SKAMP-Combined score vs placebo was demonstrated for up to 12 hours; P=0.00021

  • The efficacy of Quillivant XR was evaluated in a laboratory classroom study demonstrated in 45 children diagnosed with ADHD ages 6-12 years
  • Results from the first double-blind, placebo-controlled week of the study are summarized in the chart. The primary efficacy endpoint was the SKAMP-Combined score at 4 hours (P<0.0001). SKAMP-Combined scores were statistically lower (improved) at all measured time points (45 minutes, 2, 4, 8, 10, and 12 hours) post-dosing with Quillivant XR compared to placebo1

*The SKAMP (Swanson, Kotkin, Agler, M-Flynn, and Pelham) rating scale, often used in clinical trials, is a validated rating instrument, used by trained raters to specifically measure the observed classroom manifestations of ADHD. The items of the SKAMP are specific for place, the classroom, and time, a typical class period. The scale’s items describe typical behaviors in a classroom setting, and additional items that describe behaviors associated with ADHD in the classroom. The SKAMP method of assessment has been demonstrated to be a sensitive measure of attention and behavior within a lab classroom setting.2

As demonstrated by the SKAMP-Combined scores.

QuilliChew ER significantly improved attention and behavior compared to placebo

45 Minutes

QuilliChew ER was effective at 45 minutes as measured by SKAMP1

2, 4, 8, 10, 12,
and 13 Hours

The primary efficacy endpoint was the average of treatment effects across all time points—0.75, 2, 4, 8, 10, 12, and 13 hours—using the SKAMP*-Combined score measured during the laboratory classroom day

8 Hours

The key secondary endpoint demonstrated improvement compared to placebo in attention and behavior with an onset at 45 minutes through 8 hours duration

  • The efficacy of QuilliChew ER was evaluated in a double-blind, randomized, placebo-controlled, parallel group, laboratory classroom in 90 children ages 6-12 years old with a diagnosis of ADHD based upon criteria in the DSM-IV

*The SKAMP (Swanson, Kotkin, Agler, M-Flynn, and Pelham) rating scale, often used in clinical trials, is a validated rating instrument, used by trained raters to specifically measure the observed classroom manifestations of ADHD. The items of the SKAMP are specific for place, the classroom, and time, a typical class period. The scale’s items describe typical behaviors in a classroom setting, and additional items that describe behaviors associated with ADHD in the classroom. The SKAMP method of assessment has been demonstrated to be a sensitive measure of attention and behavior within a lab classroom setting.1