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Objective: DR/ER-MPH (formerly HLD200) is an evening-dosed delayed-release and extended-release methylphenidate approved for the treatment of ADHD in patients ≥6 years. Post hoc analyses of two pivotal Phase 3 trials: HLD200-107 (NCT02493777) and HLD200-108 (NCT02520388) evaluated emotional lability (EL) with DR/ER-MPH treatment., Methods: Differences in Conners Global Index-Parent (CGI-P) EL subscale scores and age- and gender-adjusted T -scores over an open-label titration phase (HLD200-107) and between treatment and placebo groups at endpoint (HLD200-108) were evaluated., Results: In HLD200-107 ( N  = 117) mean CGI-P EL subscale scores improved from 5.3 to 1.3 ( p  < .0001) after 6 weeks; in HLD200-108 significant improvements were observed in the treatment group ( n  = 81) versus placebo ( n  = 80; 3.11 vs. 4.08; p  = .0053). T -scores showed an improvement with DR/ER-MPH treatment in both trials. Few emotional adverse events (AEs) were reported., Conclusion: DR/ER-MPH treatment resulted in statistically significant improvements in EL to the level of non-ADHD peers as contextualized by T -scores., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: VKA: Advisory Board/Consultant—Ironshore, Neos, Rho, Shire; Speakers Bureau—Ironshore Pharmaceuticals Inc., Lundbeck/Takeda. FAL: Consultant, Speaker, and/or Research Support—Cingulate, Corium, Eli Lilly, GSK, Ironshore, Neos, Novartis, Noven, Pfizer, Rhodes, Shionogi, Shire, Sunovion, Supernus, Tris. ACC: Research Support—Acadia, Akili Interactive Labs, Allergan, Arbor Pharmaceuticals, LLC, Axial, Cingulate, Corium, Emalex, Forest Laboratories, Ironshore, KemPharm, Inc., Lumos, Neos Therapeutics, Neurocentria, Otsuka America Pharmaceutical, Inc., Purdue Pharma, Rhodes Pharmaceuticals, Servier, Shire, Sunovion Pharmaceuticals, Inc., Supernus Pharmaceuticals, Inc., Takeda Pharmaceutical Company Ltd., Tris Pharma, Advisory Board—Adlon, Akili Interactive Labs, Arbor Pharmaceuticals, LLC, Cingulate Therapeutics, Otsuka America Pharmaceutical, Inc., Pfizer, Purdue Pharma, Shire, Sunovion Pharmaceuticals, Inc., Supernus Pharmaceuticals, Inc., Takeda Pharmaceutical Company Ltd., Tris Pharma; Consultant—Arbor Pharmaceuticals, LLC, Aytu, Attentive Therapeutics, Corium, Ironshore, KemPharm, Inc., Lumos, Neos Therapeutics, Neurocentria, ., Purdue Pharma, Sunovion Pharmaceuticals, Inc., Supernus Pharmaceuticals, Inc., Tris Pharma; Speakers Bureau—Ironshore, Takeda Pharmaceutical Company Ltd., Tris Pharma; Writing Support—Arbor Pharmaceuticals, LLC, Ironshore, Neos Therapeutics, Pfizer, Purdue Pharma, Rhodes Pharmaceuticals, Shire, Sunovion Pharmaceuticals, Inc., Takeda Pharmaceutical Company Ltd., Tris Pharma. MDP, CLU, LC, and BI: Employees—Ironshore. FRS: Employee—Ironshore; Advisory Board/Board of Directors—P2D Bioscience.

Objective: The Before School Functioning Questionnaire and Parent Rating of Evening and Morning Behavior-Revised assess early morning (BSFQ, PREMB-R AM subscale) and late afternoon/evening (PREMB-R PM subscale) functional impairment in children with ADHD. Clinically meaningful improvements were identified and applied to a trial of delayed-release and extended-release methylphenidate (DR/ER-MPH) in children with ADHD (NCT02520388) to determine if the statistically-determined improvements in functional impairment were also clinically meaningful., Method: Clinically meaningful improvements in BSFQ/PREMB-R were established post hoc by receiver operating characteristics curves, using anchors of Clinical Global Impression-Improvement (CGI-I) = 1 and CGI-I ≤ 2. Percentages of participants achieving these thresholds were calculated., Results: Thresholds for CGI-I = 1/CGI-I ≤ 2, respectively, were 27/20 (BSFQ), 5/3 (PREMB-R AM), and 9/5 (PREMB-R PM)-point decreases. More children achieved clinically meaningful improvements with DR/ER-MPH versus placebo (all p  < .05)., Conclusion: DR/ER-MPH increased proportions of children achieving clinically meaningful improvements in BSFQ and PREMB-R.