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

Clin Ther. 2023 Sep 26:S0149-2918(23)00354-5. doi: 10.1016/j.clinthera.2023.09.009. Online ahead of print.ABSTRACTPURPOSE: 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 titration.METHODS: An analysis of AEs spontaneously reported to Ironshore in postmarketing surveillance included, where available, age, dose, timing, and discontinuations. Data were summarized using descriptive statistics.FINDINGS: A total of 395 children, adolescents, and adults reported 601 AEs in postmarketing surveillance. Five AEs were classified as serious. AEs preceded drug use discontinuation in 172 patients. Many AEs occurred early (52% were reported within 30 days) and at lower doses (54% were reported at 20 to 40 mg), similar to the trial data. Reported AEs included those similar in type but orders of magnitude lower in number than those from the clinical trial.IMPLICATIONS: No new safety concerns were revealed in this real-world setting compared with the safety profile identified in DR/ER-MPH trial data. In real-world practices, clinicians tended to discontinue DR/ER-MP...
Source: Clinical Therapeutics - Category: Drugs & Pharmacology Authors: Source Type: research