See the latest published material from industry experts about Highland and our products.
A Randomized, Double-Blind, Placebo-Controlled Study of HLD200, a Delayed-Release and Extended-Release Methylphenidate, in Children with Attention-Deficit/Hyperactivity Disorder: An Evaluation of Safety and Efficacy Throughout the Day and Across Settings
"DR/ER-MPH was well tolerated and demonstrated significant improvements versus placebo in functional impairment throughout the day across different settings in children with ADHD."
Functional Impairment in Youth With ADHD: Normative Data and Norm-Referenced Cutoff Points for the Before School Functioning Questionnaire and the Parent Rating of Evening and Morning Behavior Scale, Revised
"The norms generated by this study can guide clinicians in the use of the BSFQ and PREMB-R for identifying those ADHD youth who may be experiencing difficulties in the early morning and late afternoon/evening. Such tools are needed given the availability of treatments that can target ADHD symptoms and impairments at these extremes of the daily routine."
"Several types of insomnia and sleep problems are associated with methylphenidate treatment. Study design and sample features influence the RR statistic. By showing that the rate of placebo AEs impacts the RR, this study provides the field with a useful covariate for adjusting RR statistics."
"Model-based pharmacokinetic pharmacodynamic approaches can be applied to aid the development of novel formulations and individualize therapy with existing drugs."
November 3, 2019
Pharmacokinetics of HLD200, a Delayed-Release and Extended-Release Methylphenidate: Evaluation of Dose Proportionality, Food Effect, Multiple-Dose Modeling, and Comparative Bioavailability with Immediate-Release Methylphenidate in Healthy Adults
"Evening-dosed DR/ER-MPH demonstrated dose proportionality and can be administered with or without food. Significant accumulation is unlikely with multiple dosing."
November 1, 2018
Single-Dose Pharmacokinetics of HLD200, a Delayed-Release and Extended-Release Methylphenidate Formulation, in Healthy Adults and in Adolescents and Children with Attention-Deficit/Hyperactivity Disorder
"Evening-dosed HLD200 produces the intended DR and ER pharmacokinetic profile that provides a consistent predictable delay in initial MPH release until the early morning, followed by extended release across the day. The body weight-adjusted pharmacokinetics of HLD200 were similar between adults and adolescents and children with ADHD."
"The investigator-rated BSFQ should be used in future trials of ADHD medications aimed at assessing efficacy in the morning before school."
"The DPREMB-R morning score could be a useful instrument for assessing treatment efficacy in the morning before school."
"DR/ER-MPH was generally well tolerated and demonstrated significant improvements versus placebo in ADHD symptoms and at-home functional impairments in the early morning, late afternoon, and evening in children with ADHD."
"EMF impairments exert a pervasive and significantly negative emotional and functional burden on not only the primary caregiver but also on the spouse/partner and siblings. This work suggests that adequate ADHD symptom control during the early morning period may be an unmet need for school-age children with ADHD being treated with stimulants. More work is needed to confirm this finding and determine the degree to which symptom control at other times of day is also an unmet need."
"Conclusions: Control of EMF impairments from inadequately controlled ADHD symptoms is a significant unmet need in children and adolescents with ADHD treated with stable morning doses of stimulant medications. Current orally administered stimulant treatment options have not addressed this challenge."
"Our results show that the investigator-rated BSFQ (Before-School Functioning Questionnaire) is a reliable and valid measure of the effect of ADHD symptoms on the morning behavior of children prior to arriving at school."