Getting kids with attention deficit hyperactivity disorder, or ADHD, ready for school in the morning can be frustrating, to say the least. Kids generally don’t settle down until their morning meds have taken effect. But results from a phase III trial show that an experimental drug known simply as HLD200 significantly improves early morning functioning impairment in children with ADHD.
A post-hoc analysis of a secondary outcome in the data was reported during a poster session at the American Psychiatric Association meeting in San Diego, California. The experimental drug is manufactured by Ironshore Pharmaceuticals.
Researchers used a “Before School Functioning Questionnaire” (BSFQ) to measure of early morning functional impairment in children with ADHD, comparing those who were treated with HLD200 with those treated with a placebo. They found significant reductions in mean scores on the BSFQ over three weeks in children treated with the drug.
“This new method of delivering the drug shows promise in reducing the time and effort in getting an ADHD child or adolescent ready in the morning,” Ironshore Pharmaceuticals’ Valerie Arnold, M.D., told MedPage Today. “Presently, the only other approach that parents can use to get effective blood serum levels of methylphenidate (MPH) by the morning rising time is to wake their children at 4 a.m. for a dose then returning to sleep – for both the parent and child.”
The formulation relies on DELEXIS technology for controlled release of the drug, which is designed to be taken once-daily in the evening to control symptoms throughout the following day. The medication is coated with two layers of polymer that only permits release of the drug once it has reached the colon. This allows blood serum levels of methylphenidate to not begin to increase until 8 hours after the medication is consumed.
“These findings suggest that HLD200 improves functioning across commonly reported areas of dysfunction associated with ADHD in children during early morning, before school activities,” Arnold said. “Ultimately, the hope is to provide an option for an unmet need.”
Source: MedPage Today