Health Canada has approved an expanded indication for Foquest® from Purdue Pharma Canada for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) with children and adolescents six years of age and older (as of March 12, 2019). The medication gained Health Canada approval for use in adults (18 years +) with ADHD in December 2017.
Foquest is a once-daily, long-acting methylphenidate controlled-release capsule that has an onset of action within one hour and a duration that manages symptoms throughout the day. Available in seven capsule strengths, the medication offers a sprinkle option for patients who have difficulty swallowing capsules. The capsules have a patented multi-layer release, or MLR®, delivery system which allows for both a rapid initial release and a controlled release of medication throughout the day. The maximum dose of Foquest is 70mg for age 6-17 and 100mg for age 18 and older.
The new expanded indication was based on positive results from two randomized, double-blind, placebo-controlled, parallel group clinical trials to evaluate clinical efficacy and safety. One trial included 304 children aged 6 to 12 years and found those treated with Foquest had statistically significant improvements in their ADHD symptoms compared to subjects that received placebo (p<0.0001), based on results from the clinician-rated SKAMP rating scale at the end of four weeks. The second trial (354 adolescents aged 12 to 17 years) found those treated with Foquest had statistically significant improvements in their ADHD symptoms compared to subjects that received placebo (p=0.0067), based on results from the clinician-rated ADHD-5-RS total score at the end of four weeks.
Adverse events observed with Foquest treatment mainly reflect side effects commonly associated with methylphenidate use. Very common adverse events reported by patients treated with the medication were headache, insomnia, decreased appetite and abdominal pain. Most of the events were mild to moderate in severity.
Download the product monograph here.