Time-release formulation designed for children with severe ADHD symptoms upon awakening
SAN ANTONIO (Oct. 2, 2017) ― UT Health San Antonio psychiatrist Steven Pliszka, M.D., is lead author on a study that shows a new formulation of an established medication for attention deficit hyperactivity disorder (ADHD) significantly improves severe morning symptoms.
Dr. Pliszka is the Dielmann Distinguished Chair in Psychiatry and chairman of the Department of Psychiatry. The study, published in the Journal of Child and Adolescent Psychopharmacology, evaluated a new, time-release formulation of methylphenidate.
“In the study, the children took the time-release formulation at night and it worked very well first thing in the morning,” he said. “There are several long-acting stimulants on the market to treat ADHD, but this is the first formulation that has shown improved early-morning behavior without impairing function in the afternoon and evening,” he said.
The study cited a recent survey of parents who have children with ADHD. The parents identified early morning as the most challenging time of the day for these children and the family because of behavior issues.
“Current ADHD medications can take up to two hours to take effect,” he added. “This new formulation is designed as an alternative to current medications used by children who have severely disruptive behavior in the early morning.”
The Phase 3 study was conducted at 22 institutions across the U.S. In the study, 163 children ages 6 to 12 received either the time-release formulation of methylphenidate or a placebo for three weeks.
At the end of the first week, the new formulation was superior to the placebo in reducing both early morning and late afternoon symptoms of ADHD. The main side effects were reduced appetite and insomnia, which also are common for other formulations of the drug.
“To our knowledge, this is the first clinical trial to show significant improvements in at-home early morning functional impairment without compromising at-home functioning in the late afternoon/evening with a single dose of a long-acting methylphenidate,” the study read.
Ironshore Pharmaceuticals, the maker of the new product, is seeking final Food and Drug Administration (FDA) approval with the aim of offering the new formulation in 2018.
ADHD is the most common neurodevelopmental disorder of childhood. About 5 percent of children are estimated to have the disorder, according to the Centers for Disease Control and Prevention, which adds that other studies have estimated the incidence may be as high as 11 percent. The condition, which often continues into adulthood, is characterized by developmentally inappropriate symptoms and impaired function from the time of awaking until bedtime, according to the new study.
Researchers from the following institutions also participated in the study: Massachusetts General Hospital, Boston, Mass.; Westside Medical Family Practice, Clinton, Utah; University of Tennessee Health Science Center, Memphis, Tenn.; Meridien Research, Maitland, Fla., and Bradenton, Fla.; Children’s Developmental Center, Winter Park, Fla.; Ironshore Pharmaceuticals & Development Inc., Grand Cayman, Cayman Islands; and Mount Sinai Medical Center, New York, N.Y.
Funding for the study, doi.org/10.1089/cap.2017.0084, came from Ironshore Pharmaceuticals. UT Health San Antonio received funding to conduct the study locally. Dr. Pliszka has served as a consultant for Ironshore.
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