Highland Therapeutics, in a recent press release, has said that its wholly owned subsidiary, Ironshore Pharmaceuticals & Development has dosed the first patient in the second of two pivotal studies of HLD-200.
HLD-200 is a next-generation formulation of methylphenidate that utilizes Ironshore's proprietary drug delivery platform, DELEXIS, to enable nighttime dosing of patients with Attention-Deficit Hyperactivity Disorder (ADHD).
ADHD is a neurodevelopmental psychiatric disorder in which there are significant issues with executive functions that cause attention deficits, hyperactivity, or impulsiveness which is inappropriate for an individual's age.
Earlier researches have found that it is almost possible to improve ADHD patient outcomes by dosing them at night.
"The start of the second pivotal trial is an enormous milestone and a terrific accomplishment for everyone involved in this ground-breaking research. Few studies have attempted to assess behaviors and functioning in ADHD patients during the morning routine," said David Limerick, Onshore Chief Executive Officer.
Lickrish also said that the Before School Functioning Questionnaire, or BSFQ, which was developed by Dr. Tim Wilens and Dr. Paul Hammerness at Massachusetts General Hospital, provides physicians with a new tool for assessing patients during this critical time of day.
"We believe that as awareness grows, physicians will start making questions about the morning routine a routine question and adjust their treatment options accordingly," Lickrish added.
The pivotal trial will assess as many as 140 pediatric patients between the ages of six and 12. In conjunction with the other pivotal study that Ironshore recently initiated, the current study has been designed to build upon the successful results of the exploratory Phase 3 trial, known as Clinical Endpoint Evaluation Study, which was completed in 2014.