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SAN DIEGO -- Yet another new formulation of long-acting methylphenidate may ease the stress of getting children with ADHD ready for school in the morning, researchers reported here.

In a post-hoc analysis of a secondary outcome from a phase III trial, those on HLD200 had significant reductions in mean scores on the Before School Functioning Questionnaire (BSFQ), a measure of early morning functional impairment, over 3 weeks compared with those on placebo (0.91 versus 1.43, P=0.0002), Valerie Arnold, MD, of Ironshore Pharmaceuticals, reported during a poster session at the here.

"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," Arnold 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 and then returning to sleep -- for both the parent and child."

Arnold noted that the formulation relies on DELEXIS technology for controlled release of the drug, which is to be taken once-daily in the evening to control symptoms throughout the day. The medication is coated with two layers of polymer that only permits release of the drug once it has reached the colon. Thus, blood serum levels of methylphenidate do not begin to increase until 8 hours after the medication is consumed.

Primary results of the phase III trial, which enrolled 163 children ages 6 to 12 at 22 sites, showed that the drug improved ADHD symptoms and reduced overall at-home functional impairment during the early morning, late afternoon, and evening compared with placebo.

The validated 20-item BSFQ, a key secondary endpoint, was used to measure early morning functional impairment after 3 weeks on treatment.

The researchers noted that at baseline, the mean BSFQ scores were comparable between the drug and groups (2.21 and 2.24, respectively). Similarly, there were no significant baseline differences between treatment groups across any of the 20 individual items on the questionnaire.

In addition to finding a significant reduction in overall BSFQ scores for those on the drug compared with placebo, the researchers also found that mean individual item scores were significantly reduced in 19 out of 20 items in children on HLD200 versus those on placebo (P<0.001 for time awareness, listening, attention; P<0.01 for being quiet, following directions, distraction, talkativeness, forgetfulness, organization, silliness, hygiene, breakfast, interrupting, getting to school; and P<0.05 for procrastination, independence, awaiting turn, hyperactivity, and dressing).

The only item with no significant difference was misplacing/losing items, Arnold said.

She noted that there were no serious treatment-emergent adverse events, and all TEAEs were consistent with those for methylphenidate.

"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 told MedPage Today.

"Ultimately, the hope is to provide an option for an unmet need," she added. "Existing formulations of methylphenidate are given once daily in the morning to control ADHD symptoms for up to 12 hours; however, many can have a delay in the initial onset of action of up to 2 hours. This leaves the patient vulnerable to inadequate symptom control and impaired functioning during the early morning routine, a particularly challenging time of day for school-aged children with ADHD and their families."

HLD200 is currently under review by the FDA as a treatment for ADHD, with a decision date expected by July 30 of this year.

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