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

Steven R. Pliszka | Zendy; Timothy E. Wilens | Zendy; Samantha Bostrom | Zendy; Valerie Arnold | Zendy; Andrea Marraffino | Zendy; Andrew J. Cutler | Zendy; Frank A. López | Zendy; Norberto J. DeSousa | Zendy; Floyd R. Sallee | Zendy; Bev Incledon | Zendy; Jeffrey H. Newcorn | Zendy

Open Access

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

Author(s) -

Steven R. Pliszka,

Timothy E. Wilens,

Samantha Bostrom,

Valerie Arnold,

Andrea Marraffino,

Andrew J. Cutler,

Frank A. López,

Norberto J. DeSousa,

Floyd R. Sallee,

Bev Incledon,

Jeffrey H. Newcorn

Publication year - 2017

Publication title -

journal of child and adolescent psychopharmacology

Language(s) - English

Resource type - Journals

SCImago Journal Rank - 0.935

H-Index - 84

eISSN - 1557-8992

pISSN - 1044-5463

DOI - 10.1089/cap.2017.0084

Subject(s) - evening , morning , methylphenidate , attention deficit hyperactivity disorder , placebo , psychology , population , adverse effect , clinical endpoint , medicine , randomized controlled trial , psychiatry , pediatrics , physics , alternative medicine , environmental health , pathology , astronomy

Evening-dosed HLD200 is a delayed-release and extended-release methylphenidate (DR/ER-MPH) formulation consisting of uniform, dual-layered microbeads with an inner drug-loaded core. DR/ER-MPH is designed to delay the initial release of drug by 8-10 hours, and thereafter, provide a controlled, extended drug release to target onset of effect upon awakening that lasts into the evening. This phase 3 study evaluated the safety and efficacy of DR/ER-MPH on symptoms and temporal at-home functional impairment in children with attention-deficit/hyperactivity disorder (ADHD).

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