ABOUT FOQUEST®

HELPING PATIENTS

Demonstrated Safety Data

Adverse events (AEs) observed with FOQUEST®
mainly reflect those commonly associated with methylphenidate use.

number Children

ADHD patients have been evaluated in FOQUEST® clinical trials

  • 582 adults
  • 293 adolescents (12-17 years)
  • 156 children (6-12 years)

Very common AEs reported in patients treated with FOQUEST® were:

  • Headache
  • Insomnia
  • Decreased appetite
  • Abdominal pain1

Most of the events were mild or moderate in severity.1

Additional safety information

Children (6-12 years)

children

Children

(6-12 years)

Very common treatment-emergent adverse events reported by ≥1% of children with ADHD in a laboratory classroom study with an up to 6-week open-label titration phase, followed by a 1-week double-blind treatment phase1*

Adapted from FOQUEST® product monograph.
* Randomized, double-blind, placebo-controlled, parallel-arm, fixed-dose, multicentre trial measuring the efficacy and safety of FOQUEST® once daily in children aged 6-12 who met the DSM-5 criteria for ADHD. Following a washout period, children (n=156) entered an open-label dose optimization period of up to 6 weeks in which they were given 25 mg once daily in the morning to start, thereafter titrated once weekly from 25 mg to 35 mg to 45 mg to 55 mg to 70 mg to 85 mg FOQUEST® until an optimal dose was reached. Subjects (n=147) then entered 1-week of randomized double-blind treatment with placebo (n=75) or FOQUEST® capsules (n=73) at the optimized dose. (Note, the maximum recommended daily dose of FOQUEST® is 70 mg in children 6 to <18 years of age.1). At the end of the week, investigators evaluated attention and behaviour of subjects in a laboratory classroom setting using the SKAMP rating scale. The primary efficacy endpoint was the difference between FOQUEST® and placebo in mean SKAMP-C score across the entire laboratory classroom trial.

Serious Adverse Events (AEs) and AEs Leading to Treatment Discontinuation

During the double-blind treatment phase of the placebo-controlled trial in children:

  • There were no discontinuations due to AEs or serious adverse events (SAEs)

During the open-label period:

  • 1.3% (2/156) of FOQUEST®-treated patients discontinued treatment due to AEs
    • 1 subject (0.6%) with affect lability and dermatillomania and 1 subject (0.6%) with ECG PR prolongation
  • No SAEs were reported

Adolescents (12-17 years)

Adolescents

Adolescents

(12-17 years)

Very common treatment-emergent adverse events reported by ≥5% of adolescents with ADHD treated with FOQUEST® in a 6-month open-label clinical trial1

Adolescents

Adapted from FOQUEST® product monograph.

The incidence of abdominal pain in the 4-week double-blind trial was 1.0% (3/293).1

Serious Adverse Events (AEs) and AEs Leading to Treatment Discontinuation

During the double-blind treatment phase of the placebo-controlled trial in adolescents:

  • 3.4% (10/293) of FOQUEST®-treated patients discontinued treatment due to AEs
    • AEs that led to discontinuation were: irritability (3 subjects [1.0%]), anxiety, delirium, depressed mood, dysphoria, suicidal ideation, dizziness, and headache (each one of 293 subjects, 0.3%).
  • No SAEs were reported

During the 6-month open-label safety trial:

  • 5.0% (9/179) of subjects discontinued due to AEs: one subject each (0.6%) with asthma exacerbation, depressed mood, flat affect, generalized anxiety disorder, insomnia, decreased appetite, headache, urticaria chronic, and severe aggressive behaviour
  • 2 subjects experienced SAEs, including asthma exacerbation and severe aggressive behaviour

Adults (≥18 years)

adults

Adults

(≥18 years)

Very common treatment-emergent adverse events reported by ≥1% of children with ADHD in a laboratory classroom study with an up to 7-week open-label titration phase, followed by a 1-week double-blind treatment phase1†

adults Adapted from FOQUEST® product monograph.
† Randomized, double-blind, multicentre, placebo-controlled trial involving 285 adult patients (18 to 60 years of age) who met the DSM-5 criteria for ADHD. Following an up to 7 week dose optimization period (FOQUEST® titrated from 25 mg to 100 mg), patients entered a one-week randomized, double-blind treatment with FOQUEST® (n=121; full analysis set) or placebo (n=118; full analysis set). At the end of this week, subjects completed an age-adjusted math test assessment in a laboratory classroom setting using the PERMP test. The primary efficacy endpoint was the difference between FOQUEST® and placebo in mean PERMP Total score across the entire laboratory classroom trial.

Serious Adverse Events (AEs) and AEs Leading to Treatment Discontinuation

adults