@article{585ad4e9a52a4aa88f6978f0025ef929,
title = "Efficacy, Safety, and Tolerability of a Novel Methylphenidate Extended-Release Oral Suspension (MEROS) in ADHD",
abstract = "Objective: To test whether an optimal dose of Quillivant XR (methylphenidate extended-release oral suspension [MEROS]) would significantly reduce symptoms of ADHD in children. Method: A randomized, double-blind, placebo-controlled, cross-over, efficacy, safety, and tolerability study of MEROS in 45 children aged 6 to 12 years (open-label dose-optimization phase, followed by double-blind cross-over period). Results: MEROS was significantly more efficacious than placebo during double-blind cross-over laboratory classroom days (Swanson, Kotkin, Agler, M-Flynn, and Pelham Rating Scale and Permanent Product Measure of Performance). During the open-label phase, improvements were observed in scores of ADHD Rating Scale-IV, and Clinical Global Impression-Severity and -Improvement Scales. No occurrences of suicidal ideation or behavior were recorded; the most common open-label treatment-emergent adverse events were typical of stimulant use: decreased appetite, insomnia, and abdominal pain. Conclusion: MEROS was efficacious in the treatment of children aged 6 to 12 years with ADHD, with a safety profile similar to that of other extended-release methylphenidate pharmacotherapies.",
keywords = "ADHD, laboratory school, math test, methylphenidate, randomized-controlled trial",
author = "Robb, {Adelaide S.} and Findling, {Robert L.} and Childress, {Ann C.} and Berry, {Sally A.} and Belden, {Heidi W.} and Wigal, {Sharon B.}",
note = "Funding Information: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Adelaide S. Robb has been an Advisory Board member for Bristol-Myers Squibb, Eli Lilly and Company, Lundbeck, Otsuka, and Pfizer Inc.; served on a Speakers Bureau for Takeda, Otsuka, and Pfizer Inc.; received research support from Bristol-Myers Squibb, Forest Laboratories Inc., GlaxoSmithKline, Janssen Pharmaceuticals, Inc., Lundbeck, Merck/Schering-Plough Pharmaceuticals, National Institute of Child Health and Human Development (NICHD), Otsuka, and Pfizer Inc.; received travel support from American Academy of Child and Adolescent Psychiatry (AACAP) and Pfizer Inc.; and owns stocks in Eli Lilly and Company, GlaxoSmithKline, Janssen Pharmaceuticals, Inc., and Pfizer Inc. Robert L. Findling receives or has received research support, acted as a consultant, and/or served on a speaker{\textquoteright}s bureau for Alexza Pharmaceuticals, American Academy of Child & Adolescent Psychiatry, American Physician Institute, American Psychiatric Press, AstraZeneca, Bracket, Bristol-Myers Squibb, Clinsys, Cognition Group, Coronado Biosciences, Dana Foundation, Forest, GlaxoSmithKline, Guilford Press, Johns Hopkins University Press, Johnson & Johnson, KemPharm, Lilly, Lundbeck, Merck, NIH, Novartis, Noven, Otsuka, Oxford University Press, Pfizer, Physicians Postgraduate Press, Rhodes Pharmaceuticals, Roche, Sage, Seaside Pharmaceuticals, Shire, Stanley Medical Research Institute, Sunovion, Supernus Pharmaceuticals, Transcept Pharmaceuticals, Validus, and WebMD. Ann C. Childress has been a consultant to Novartis, Shionogi, NextWave Pharmaceuticals, Shire Pharmaceuticals, and Pfizer Inc.; a speaker for Novartis, Shionogi, GlaxoSmithKline, and Shire Pharmaceuticals; and received research support from Novartis, Shionogi, NextWave Pharmaceuticals, Shire Pharmaceuticals, Abbott Laboratories, Forest Laboratories, Johnson & Johnson Pharmaceutical Research & Development, LLC, Lilly USA, Ortho-McNeil Janssen Scientific Affairs, Otsuka Pharmaceutical Company Ltd, Pfizer Inc., Rhodes Pharmaceuticals LP, Sepracor Inc., Somerset Pharmaceuticals, Neos, and Theravance. Sharon B. Wigal receives or has received research support, acted as a consultant, been an Advisory Board member, and/or served on a Speakers Bureau for Addrenex Pharmaceuticals, Eli Lilly and Company, Forest Pharmaceuticals, McNeil Consumer & Specialty Pharmaceuticals, NextWave Pharmaceuticals, NIMH, Noven, NuTec Pharma Ltd., Otsuka, Inc., Pfizer Inc., Purdue, Quintiles, Rho, Rhodes Pharmaceuticals, Shionogi Inc., Shire US Inc., Sunovion, Taisho Pharmaceutical Co., and Tris Pharma, Inc. Sally A. Berry and Heidi W. Belden were employed by NextWave Pharmaceuticals, which was acquired by Pfizer Inc. Both are now consultants to Pfizer Inc., and as such, were paid contractors to Pfizer Inc. in the development of this manuscript. Adelaide S. Robb, Robert L. Findling, Ann C. Childress, and Sharon B. Wigal have declared no potential conflicts of interests with respect to the authorship and/or publication of this article. Funding Information: The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This research was sponsored by NextWave Pharmaceuticals, a wholly owned subsidiary of Pfizer Inc. Writing and editorial support for this manuscript was provided by Anne Jakobsen, MSc, of Engage Scientific and funded by Pfizer Inc. Publisher Copyright: {\textcopyright} 2014, {\textcopyright} The Author(s) 2014.",
year = "2017",
month = dec,
day = "1",
doi = "10.1177/1087054714533191",
language = "English (US)",
volume = "21",
pages = "1180--1191",
journal = "Journal of Attention Disorders",
issn = "1087-0547",
publisher = "SAGE Publications Inc.",
number = "14",
}