Adverse Events During Dosing of Delayed-Release/Extended-Release Methylphenidate: Learnings From the Open-Label Phase of a Registration Trial and a Real-World Postmarketing Surveillance Program

PURPOSE: Delayed-release/extended-release methylphenidate (DR/ER-MPH) (formerly HLD200) is an evening-dosed agent used for the treatment of attention-deficit/hyperactivity disorder. Postmarketing surveillance data from approximately 74,000 patients exposed to DR/ER-MPH (up to June 17, 2022) were reported and compared with the open-label, treatment-optimization phase of a Phase III clinical trial to derive possible learnings on how to approach adverse events (AEs) that emerge during dose…

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