SAN DIEGO — Kids with attention-deficit/hyperactivity disorder (ADHD) saw significant symptom improvement with evening-dosed stimulant, a phase III naturalistic study confirmed.
Three weeks delayed-release and extended-release methylphenidate (Jornay PM) treatment resulted in a significant improvement in ADHD symptoms versus placebo (least squares mean 54-point ADHD-Rating Scale-IV 24.1 vs 31.2, P=0.002), reported Steven Pliszka, MD, of the University of Texas Health Science Center at San Antonio, and colleagues.
There also was significant improvement in children’ ADHD symptoms with just a week of active treatment, they reported at the Psych Congress.
With its FDA approval in August 2018, Jornay PM (initially known as HLD200) became the only evening-dosed stimulant for ADHD for patients ages ≥6 years. The approval was based on prior phase III studies that showed a “consistent, predictable delay” in medication release about 8 to 10 hours after administration, into the early morning.
The drug uses a novel drug delivery platform, called Delexis, that contains microbeads with an outer delayed-release layer to giving a therapeutic effect in the morning, and an inner extended-release layer to maintain efficacy throughout the day and evening.
According to current clinical guidelines, long-acting stimulants are recommended as first-line treatment for ADHD. However, all existing methylphenidate options are administered once daily in the morning, sometimes leading to a treatment gap in the morning for children.
“There remains a significant unmet need in stimulant-treated youth with ADHD to provide clinically meaningful control of ADHD symptoms and functional impairment from the early morning into the evening,” the research group highlighted.
This naturalistic-setting analysis included children, ages 6-12, with a diagnosis of ADHD, with a baseline ADHD Rating Scale score ≥90th percentile for age and gender.
The average therapeutic dose was 68.1 mg after 3 weeks of treatment, and most children took the treatment at 8 p.m.
After 3 weeks, participants on the treatment also saw a significant improvement in all secondary endpoints looking at daily life functioning versus those on placebo. These endpoints included the Before School Function Questionnaire (BSFQ) total score (scored 0-60), the Parent Rating of Evening (PREMB-PM; scored 0-24) and Morning (PREMB-R AM; scored 0-9) Behavioral-Revised subscales:
- BSFQ: least squares mean score 18.7 with treatment vs 28.4 with placebo
- PREMB-R AM: 2.1 vs 2.6
- PREMB-R PM: 9.4 vs 12.2
Specifically, the BSFQ scale looked at children’s early morning functional impairment, including the time between awakening and getting to school (roughly 6 a.m to 9 a.m.). This scale took into account ability to perform early morning activities, such as eating breaking, time awareness and management in getting to school, and daily morning hygiene like brushing teeth.
As for the parent-reported outcomes, the PREMB-AM and PM scales assessed behaviors involved with daily morning and evening life. The morning scale had parents report on ability for their children to perform activities such as awakening and getting out of bed, while the PM scale had parents assess ability to perform activities such as completing homework and falling asleep.
“To our knowledge, this is the first study to demonstrate significant improvements in functional impairment in the early morning and late afternoon/evening with a single dose of a long-acting stimulant in children with ADHD,” the researchers pointed out.
Delayed-release and extended-release methylphenidate was also generally well-tolerated among the participants, with no serious treatment-emergent adverse event (AE) reported. The most common non-serious AEs included insomnia and decreased appetite, similar to other methylphenidate treatments. Only one participant on the active treatment withdrew early due to mood swings.
The study was funded by Ironshore.
Pliszka disclosed relevant relationships with Cingulate, Sunovion, Supemus, Ironshore, AstraZeneca, and NLS. Co-authors disclosed multiple relevant relationships with industry.