Real-World Efficacy and Safety of Extended-Release Methylphenidate (PRC-063) in the Treatment of ADHD in Pediatric and Adult Subjects: Results of a Phase IV Multicenter Comparison With Lisdexamfetamine Dimesylate

• Published in: Journal of attention disorders Vol. 27; no. 7; pp. 743 - 756
• Main Authors: van Stralen, Judy, Parhar, Gurdeep, Parhar, Anita, Tourjman, Valérie, Khattak, Sohail, Ahmed, Tahira, Donnelly, Graeme A. E., Ratz, Jodan
• Format: Journal Article
• Language: English
• Published: Los Angeles, CA SAGE Publications 01.05.2023
• Subjects: Adult; Attention Deficit Disorder with Hyperactivity - chemically induced; Attention Deficit Disorder with Hyperactivity - drug therapy; Central Nervous System Stimulants - adverse effects; Child; Dextroamphetamine - adverse effects; Dose-Response Relationship, Drug; Double-Blind Method; Humans; Lisdexamfetamine Dimesylate - therapeutic use; Methylphenidate - adverse effects; Quality of Life; Treatment Outcome; methylphenidate; real-world; ADHD; lisdexamfetamine dimesylate; PRC-063
• ISSN: 1087-0547; 1557-1246; 1557-1246
• DOI: 10.1177/10870547231172767

Objective: To evaluate the real-world efficacy, safety, and functional outcomes of PRC-063 (multilayer-release methylphenidate) versus lisdexamfetamine (LDX) in ADHD subjects in a phase IV, open-label study. Method: The primary endpoint was the change in the ADHD-DSM-5 Rating Scale (ADHD-5-RS) total score from baseline to Month 4. Secondary endpoints included a non-inferiority comparison between PRC-063 and LDX and measures of functioning and evening behavior. Results: One hundred forty-three pediatric and 112 adult subjects were enrolled. Mean ADHD-5-RS scores (standard deviation) were reduced in pediatric (−16.6 [10.4]) and adult (−14.8 [10.6]) subjects treated with PRC-063 (p < .001). PRC-063 was non-inferior to LDX in the pediatric population but not in the adult population. Significant improvements were demonstrated in quality of life and functionality. Both medications were well-tolerated; more adverse events led to study discontinuation in pediatric subjects treated with LDX versus PRC-063. Conclusion: PRC-063 and LDX significantly improved ADHD symptomatology and functioning and were well-tolerated.