Publications

See the latest published material from industry experts about Ironshore and our products.

PUBLICATIONS


2022

2022

Quantitative Characterization of the Smoothness of Extended-release Methylphenidate Pharmacokinetic Profiles

Po MD, PhD; Gomeni R, PhD; Incledon B, PhD – In press at Innovations in Clinical Neuroscience

2022

Effect of Colonic Absorption on the Pharmacokinetic Properties of Delayed-Release and Extended-Release Methylphenidate: In Vivo, In Vitro, and Modeling Evaluations

Incledon B, PhD; Incledon C, MSc; Gomeni R, PhD; Uchida CL, PhD; Morris A, Perry K, PhD; Kapuscinski J – Clinical Pharmacology in Drug Development

2022

Clinically Meaningful Improvements in Early Morning and Late Afternoon/Evening Functional Impairment in Children with ADHD Treated with Delayed-Release and Extended-Release Methylphenidate

Wilens TE, MD; Faraone SV, PhD; Hammerness PG, MD; Pliszka SR, MD; Uchida CL, PhD; DeSousa NJ, MA; Sallee FR, MD, PhD; Incledon B, PhD; Newcorn JH, MD – Journal of Attention Disorders. 

2021

2021

Effect of Delayed-Release and Extended-Release Methylphenidate on Caregiver Strain and Validation of Psychometric Properties of the Caregiver Strain Questionnaire: Results from a Phase 3 Trial in Children with Attention-Deficit/Hyperactivity Disorder

López FA, MD; Faraone SV, PhD; Newcorn JH, MD; Doll HA, DPhil; Rhoten S, PhD; Lewis HB, PhD; Khan TF, MPH; DeSousa NJ, MA; Sallee FR, MD, PhD; Incledon B, PhD – Journal of Child and Adolescent Psychopharmacology

2021

Symptomatic and Functional Response and Remission From the Open-Label Treatment-Optimization Phase of a Study With DR/ER-MPH in Children With ADHD

Childress AC, MD; Cutler AJ, MD; Po MD, PhD; DeSousa NJ, MA; Warrington LE, MD; Sallee FR, MD, PhD; Incledon B, PhD Journal of Clinical Psychiatry

2020

2020

A Post Hoc Comparison of Prior ADHD Medication Dose and Optimized Delayed-release and Extended-release Methylphenidate Dose in a Pivotal Phase III Trial

Ann C. Childress, MD; Cassandra L. Uchida, PhD; Michelle D. Po, PhD; Norberto J. DeSousa, MA; and Bev Incledon, PhD – Clinical Therapeutics

2020

Model-Based Approach for Establishing the Predicted Clinical Response of a Delayed-Release and Extended-Release Methylphenidate for the Treatment of Attention-Deficit/Hyperactivity Disorder

Robert Gomeni, PhD; Marina Komolova, PhD; Bev Incledon, PhD; Stephen V Faraone, PhD – Journal of Clinical Psychopharmacology

February, 2020

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

Ann C. Childress, MD, Andrew J. Cutler, MD, Andrea Marraffino, PhD, Mary Ann McDonnell, RN, FPNP, PhD, John M. Turnbow, MD, Matthew Brams, MD, Norberto J. DeSousa, MA, Bev Incledon, PhD, Floyd R. Sallee, MD, PhD, and Sharon B. Wigal, PhD — Journal of Child and Adolescent Psychopharmacology

"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."

2020

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

Stephen V. Faraone, PhD; Norberto J. DeSousa, MA; Marina Komolova, PhD; F. Randy Sallee, MD, PhD; Bev Incledon, PhD; and Timothy E. Wilens, MD — Journal of Clinical Psychiatry

"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."

2019

2019

Sleep-associated adverse events during methylphenidate treatment of attention-deficit/hyperactivity disorder: a meta-analysis.

Stephen V. Faraone, PhD; Michelle D. Po, PhD; Marina Komolova, PhD; and Samuele Cortese, MD, PhD — Journal of Clinical Psychiatry

"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."

November, 2019

An update on the pharmacokinetic considerations in the treatment of ADHD with long-acting methylphenidate and amphetamine formulations

Ann C. Childress, Marina Komolova & F. Randy Sallee — Expert Opinion on Drug Metabolism & Toxicology

"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

Tao Liu, PhD, Jogarao V.S. Gobburu, PhD, MBA, Michelle D. Po, PhD, Angus McLean, PhD, Norberto J. DeSousa, MA, Floyd R. Sallee, MD, PhD, and Bev Incledon, PhD — Journal of Child and Adolescent Psychopharmacology

"Evening-dosed DR/ER-MPH demonstrated dose proportionality and can be administered with or without food. Significant accumulation is unlikely with multiple dosing."

2018

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

Ann Childress, MD, Shailly Mehrotra, BPharm, Jogarao Gobburu, PhD, MBA, Angus McLean, PhD, Norberto J. DeSousa, MA, and Bev Incledon, PhD — Journal of Child and Adolescent Psychopharmacology

"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."

September, 2018

Reliability and Validity of the Before-School Functioning Scale in Children With ADHD

Stephen V. Faraone, Paul G. Hammerness, and Timothy E. Wilens — Journal of Attention Disorders

"The investigator-rated BSFQ should be used in future trials of ADHD medications aimed at assessing efficacy in the morning before school."

September, 2018

Reliability and Validity of the Daily Parent Rating of Evening and Morning Behavior Scale, Revised

Stephen V. Faraone, Ann Childress, Sharon B. Wigal, Scott H. Kollins, Mary Ann McDonnell, Norberto J. DeSousa, and F. Randy Sallee — Journal of Attention Disorders

"The DPREMB-R morning score could be a useful instrument for assessing treatment efficacy in the morning before school."

2017

November 6, 2017

Efficacy and Safety of HLD200, Delayed-Release and Extended-Release Methylphenidate, in Children with Attention-Deficit/Hyperactivity Disorder

Steven R. Pliszka, MD, Timothy E. Wilens, MD, Samantha Bostrom, MD Valerie K. Arnold, MD, Andrea Marraffino, PhD, Andrew J. Cutler, MD, Frank A. Lopez, MD, Norberto J. DeSousa, MA, Floyd R. Sallee, MD, PhD, Bev Incledon, PhD, and Jeffrey H. Newcorn, MD — Journal of Child and Adolescent Psychopharmacology

"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."

April 10, 2017

Early Morning Functional Impairments in Stimulant-Treated Children with Attention-Deficit/Hyperactivity Disorder Versus Controls: Impact on the Family.

Faraone SV1, Schachar RJ2, Barkley RA3, Nullmeier R4, Sallee FR4. — Journal of Child and Adolescent Psychopharmacology

"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."

2015

July 9, 2015

Early Morning Functioning in Stimulant-Treated Children and Adolescents with Attention-Deficit/Hyperactivity Disorder, and its Impact on Caregivers

Floyd R. Sallee, MD, PhD — Journal of Child and Adolescent Psychopharmacology

"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."

April 10, 2017

Reliability and Validity of the Before-School Functioning Scale in Children With ADHD

Stephen V. Faraone, Paul G. Hammerness, and Timothy E. Wilens — Journal of Attention Disorders

"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."

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