Long-acting stimulants, including methylphenidate (MPH), typically show effects after a two-hour time lag in case of youngsters suffering from attention-deficit/hyperactivity disorder (ADHD). The usual practice is to administer such medication to children first thing in the morning, which is quite challenging for both children and parents as it disrupts the sleep cycle. Moreover, the delayed effect results in the unsatisfactory management of ADHD symptoms and functional impairment among children.
A new phase 3 study of children aged 6 to 12 years has found that administering an evening dose of HLD200, a delayed-release, long-acting formulation of MPH, leads to considerable improvements in early morning and day-long ADHD symptoms. Results of the study, published online in the Journal of Child and Adolescent Psychopharmacology (JCAP) on July 21, 2017, show that with an evening dose of HLD200, ADHD-affected children did not have to wait longer for the effects to surface. Improvements in late afternoon/evening functioning for children and reduced stress for caregivers was also observed.
The drug formulation, comprising dual-layered microbeads with an inner MPH-loaded core, delays release of the active ingredient for 8-10 hours. It subsequently provides controlled extended release so that the early morning and evening periods are covered. The medicine was found to be well-tolerated, although primary side-effects such as appetite suppression and insomnia commonly found in other MPH formulations were evident.
Commenting on the study’s findings, Harold S. Koplewicz, editor-in-chief of JCAP and president of the Child Mind Institute in New York, said, “Developing new formulations of effective medications for patients with ADHD improves the lives of children with the disorder.”
Burden of inadequately controlled early morning ADHD symptoms
Past research on 201 primary caregivers of children and adolescents with ADHD shows that inadequately controlled ADHD symptoms were considered most severe during the evening hours (homework time) and early morning (while getting ready for school). Despite routinely administering morning doses of stimulant medicines, nearly 75.6 percent caregivers associated early mornings with moderate-to-severe ADHD-related functional impairment in their children. A more recent study, published in JCAP in April 2017, found that early morning functional (EMF) impairment in ADHD youth treated with stimulants resulted in significant reduction of caregivers’ emotional well-being and exerted tremendous pressure on the entire family.
Findings from such studies suggest that inadequate control of early morning ADHD symptoms and EMF impairment continue to be extremely onerous for ADHD youth treated with stimulants as well as their families. Although the significant burden of EMF impairment is well-established, it remains an understudied area for children and adolescents. So far, research on stimulant-treated children with ADHD has mainly focused on improving symptoms during the school and homework time, although the condition is characterized by adverse symptoms and impaired functioning from the time a child wakes up till his/her bedtime.
So far, the effectiveness of a long-acting stimulant on at-home EMF impairment has been evaluated by only one 4-week study on 30 children with ADHD – administration of an MPH transdermal patch showed a significant reduction in EMF impairment compared to a placebo. However, very early morning administration is difficult if done before normal wake-up time; it is only possible with a patch formulation in which the child need not be awake. Moreover, early morning dosage may potentially diminish late afternoon/early evening ADHD coverage.
Addressing unmet needs for effective ADHD medication
According to the researchers, the delayed-release, long-acting action of HLD200, administered as an evening dose, has been specifically designed to manage the unmet need for a once-daily ADHD medication which will be effective upon awakening without compromising on later-day efficacy. Although there are wide variations in ADHD estimates among American children/adolescents, it remains one of the most common neuro-developmental childhood disorder which, if left untreated, can continue into adulthood. The study findings are important for effective ADHD treatment among youngsters.
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