5.12 ELECTRONICALLY MONITORED ADHERENCE RATES WITH EVENING-DOSED DELAYED-RELEASE AND EXTENDED-RELEASE METHYLPHENIDATE IN CHILDREN WITH ADHD

Objectives: HLD200, a delayed-release and extended-release methylphenidate (DR/ER-MPH), is the first evening-dosed stimulant designed to provide an all-day treatment effect from waking into the evening. In 2 pivotal phase-3 trials in children (6 to 12 years old) with ADHD, DR/ER-MPH was well tolerated and demonstrated symptomatic and functional improvement vs placebo throughout the day and into the evening. Here, we report the medication adherence rates from these trials. Methods: HLD200-107 (NCT02493777) included a 6-week, open-label, DR/ER-MPH titration phase (dose: 20-100 mg/d; dosing time: 8:00 PM ± 1.5 h) followed by randomization to double-blind, treatment-optimized DR/ER-MPH or placebo for 1 week ending with a laboratory classroom test day. HLD200-108 (NCT02520388) was a 3-week, randomized, double-blind, placebo-controlled, forced-dose titration trial (dose: 40–80 mg/d; dosing time: 8:00 PM ± 1.5 h). In both trials, adherence was measured with the Medication Event Monitoring System (MEMS®), a device that records the date/time of cap openings. Participants were categorized as daily adherent if a cap opening occurred at least once in a 24-hour period and were categorized as timing adherent if an opening occurred within 30 minutes of the prescribed dosing time interval. Mean rates of adherence in each week were reported. Results: During the open-label DR/ER-MPH titration phase of HLD200-107, mean daily adherence (N = 117) ranged from 96% to 98%, and mean timing adherence ranged from 80% to 90%. During the double-blind phase, mean daily adherence was 99% for DR/ER-MPH (n = 64) and 98% for placebo (n = 53), and mean timing adherence was 93% and 89%, respectively. In HLD200-108, mean daily adherence ranged from 89% to 94% for DR/ER-MPH (n = 81) and placebo (n = 80), and mean timing adherence ranged from 67% to 73% for DR/ER-MPH and 64% to 71% for placebo. Conclusions: In 2 trials, daily adherence to evening-dosed DR/ER-MPH was >89% in all weeks, and the mean timing adherence rates ranged from 67% to 93%. These timing adherence rates were greater than those previously reported with once-daily morning-dosed stimulants in children and adults with ADHD. Although caution should be taken when making comparisons across trials, these data suggest that evening dosing of DR/ER-MPH is well accepted by parents and children. ADHD, STIM, TREAT