A potential new treatment option for pediatric patients with attention deficit hyperactivity disorder (ADHD) is currently under investigation, according to data presented at the 2017 American Psychiatric Association Annual Meeting, held May 20 -24, in San Diego, California.
Ironshore Pharmaceuticals & Development, Inc., a wholly owned subsidiary of Highland Therapeutics Inc., announced that it has presented phase 3 clinical data from a study investigating the tolerability and efficacy of HLD200 to the US Food and Drug Administration (FDA). HLD200 is being developed to address Early Morning Functioning (EMF) impairments – difficulties that occur immediately upon awakening until going to school or performing other morning activities — in children with ADHD.
A series of 4 poster presentations revealed first-time data about the trial, which was conducted during the summer and fall of 2015 through spring 2016 in 163 children between the age of 6 and 12. The findings included:
- HLD200 significantly improved ADHD symptom control and at-home early morning and late afternoon/evening functioning compared with placebo
- Caregivers reported a significant improvement in childrens’ ADHD symptoms with HLD200, which coincided with reductions in caregiver strain
- Evening-dosed HLD200 produced the intended 8- to 10-hour delay in initial methylphenidate release, followed by a period of extended, controlled release, which resulted in an ascending absorption profile that coincided with the early morning and afternoon
“If approved, HLD2000 would become the first product to treat ADHD that can be taken the evening before and is effective for treating early morning functioning problems in children with ADHD,” Steven R. Pliszka, MD, Dielmann Distinguished Professor and chair of the department of psychiatry, University of Texas Health Science Center in San Antonio, said in an interview with Psychiatry Advisor.
“Only children participated but adolescents have these early morning problems as well,” Dr Pliszka added in reference to limitations to this study. “All patients had at least a partial response to the daytime dose of methylphenidate (the active product). While it is unlikely, medication naïve children might respond differently.”
Ironshore Pharmaceuticals Presents Pivotal Trial Data at American Psychiatric Association Meeting [news release]. Ironshore Pharmaceuticals: George Town, Cayman Islands; April 12, 2017. http://www.businesswire.com/news/home/20170523006245/en/Ironshore-Pharmaceuticals-Presents-Pivotal-Trial-Data-American. Accessed May 25, 2017.