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