New ADHD Medication May Ease Morning Routines
A new long-acting methylphenidate — known for now as HLD200 — may provide a unique solution to a longstanding problem: inadequate control of ADHD symptoms during the morning hours.
May 31, 2017
Parents of children with ADHD often report that the morning hours–the time immediately upon waking until the child leaves for work or school–is one of the busiest and most chaotic times in the household. Inadequate control of ADHD symptoms makes the morning routine a household challenge and daily aggravation. Now, a new formulation of long-acting methylphenidate — designed to solve this common problem — is currently under review by the FDA. The medication, known for the time being as HLD200, is taken at night, instead of first thing in the morning, and was shown in research to significantly control early-morning symptoms.
HLD200 is manufactured by Ironshore Pharmaceuticals, and was designed with a unique formulation: it’s taken once daily, before the child goes to bed. The coating on the medication dissolves after 8 hours, at which point the medication starts to enter the bloodstream.
Results from a Phase III trial on HLD200’s effectiveness (the final phase of research required before FDA approval) were presented during the American Psychiatric Association’s 2017 Annual Meeting, held in San Diego from May 20 to May 24. The study enrolled 163 children between the ages of 6 and 12 for a three-week medication trial. Compared with children taking a placebo, children on HLD200 showed significant improvement on the Before School Functioning Questionnaire (BSFQ), a validated 20-question test that measures a child’s morning performance.
The medication continued to work throughout the day, researchers said, improving function all the way through early evening. Children taking HLD200 saw improvement on 19 of 20 measures on the BSFQ, including “silliness,” “hygiene,” and “following directions.”
Most long-acting ADHD medications are taken in the morning, and some parents resort to extreme methods — such as waking their child at 4 AM to administer medication so as to control ADHD symptoms during the morning routine.
“Ultimately, the hope is to provide an option for an unmet need,” said study author Valerie Arnold, M.D. “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.”
The FDA should make a decision on HLD200 by July 30, the researchers said. If the medication is approved, it will become available to the general public shortly afterwards.