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

Overview

Journal J Atten Disord

Publisher Sage Publications

Specialty Psychiatry

Date 2023 May 5

PMID 37144295

Authors

Judy van Stralen

Gurdeep Parhar

Anita Parhar

Valerie Tourjman

Sohail Khattak

Tahira Ahmed

Graeme A E Donnelly

Jodan Ratz

Affiliations

Soon will be listed here.

Abstract

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 ( < .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.

Citing Articles

Switch to Lisdexamfetamine in the Treatment of Attention-Deficit Disorder at a Psychiatric Outpatient Clinic for School-Aged Children: A Danish Cohort Study.

Sondergaard N, Noroxe K, Carlsen A, Randing S, Warrer P, Thomsen P J Child Adolesc Psychopharmacol. 2024; 34(3):137-147.

PMID: 38608011 PMC: 11040185. DOI: 10.1089/cap.2023.0077.

Comorbidity of attention deficit hyperactivity disorder in a patient with epilepsy: Staring down the challenge of inattention versus nonconvulsive seizures.

Miller D, Komanapalli H, Dunn D Epilepsy Behav Rep. 2024; 25:100651.

PMID: 38357032 PMC: 10865219. DOI: 10.1016/j.ebr.2024.100651.

References

Unger J, Hershman D, Fleury M, Vaidya R . Association of Patient Comorbid Conditions With Cancer Clinical Trial Participation. JAMA Oncol. 2019; 5(3):326-333. PMC: 6439841. DOI: 10.1001/jamaoncol.2018.5953. View

Childress A, Brams M, Cutler A, Donnelly G, Bhaskar S . Efficacy and Safety of Multilayer, Extended-Release Methylphenidate (PRC-063) in Children 6-12 Years of Age with Attention-Deficit/Hyperactivity Disorder: A Laboratory Classroom Study. J Child Adolesc Psychopharmacol. 2020; 30(10):580-589. PMC: 7757528. DOI: 10.1089/cap.2020.0109. View

Mowlem F, Rosenqvist M, Martin J, Lichtenstein P, Asherson P, Larsson H . Sex differences in predicting ADHD clinical diagnosis and pharmacological treatment. Eur Child Adolesc Psychiatry. 2018; 28(4):481-489. PMC: 6445815. DOI: 10.1007/s00787-018-1211-3. View

Weiss M . A Paradigm for Targeting Functional Impairment as an Outcome in Attention-Deficit/Hyperactivity Disorder. Brain Sci. 2022; 12(8). PMC: 9405930. DOI: 10.3390/brainsci12081014. View

Pitts M, Mangle L, Asherson P . Impairments, diagnosis and treatments associated with attention-deficit/hyperactivity disorder (ADHD) in UK adults: results from the lifetime impairment survey. Arch Psychiatr Nurs. 2015; 29(1):56-63. DOI: 10.1016/j.apnu.2014.10.001. View

Soutullo C, Banaschewski T, Lecendreux M, Johnson M, Zuddas A, Anderson C . A post hoc comparison of the effects of lisdexamfetamine dimesylate and osmotic-release oral system methylphenidate on symptoms of attention-deficit hyperactivity disorder in children and adolescents. CNS Drugs. 2013; 27(9):743-51. PMC: 3751426. DOI: 10.1007/s40263-013-0086-6. View

Weiss M, McBride N, Craig S, Jensen P . Conceptual review of measuring functional impairment: findings from the Weiss Functional Impairment Rating Scale. Evid Based Ment Health. 2018; 21(4):155-164. PMC: 6241626. DOI: 10.1136/ebmental-2018-300025. View

Faraone S, Childress A, Wigal S, Kollins S, McDonnell M, DeSousa N . Reliability and Validity of the Daily Parent Rating of Evening and Morning Behavior Scale, Revised. J Atten Disord. 2015; 22(11):1066-1073. DOI: 10.1177/1087054715619009. View

Wigal T, Brams M, Gasior M, Gao J, Squires L, Giblin J . Randomized, double-blind, placebo-controlled, crossover study of the efficacy and safety of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder: novel findings using a simulated adult workplace environment design. Behav Brain Funct. 2010; 6:34. PMC: 2908054. DOI: 10.1186/1744-9081-6-34. View

10.

Childress A, Cutler A, Marraffino A, Bhaskar S, Donnelly G . Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Adult Laboratory Classroom Study of the Efficacy and Safety of PRC-063 (Extended-Release Methylphenidate) for the Treatment of ADHD. J Atten Disord. 2021; 26(6):857-869. PMC: 8859679. DOI: 10.1177/10870547211025610. View

11.

Brod M, Johnston J, Able S, Swindle R . Validation of the adult attention-deficit/hyperactivity disorder quality-of-life Scale (AAQoL): a disease-specific quality-of-life measure. Qual Life Res. 2006; 15(1):117-29. DOI: 10.1007/s11136-005-8325-z. View

12.

Faraone S, DeSousa N, Komolova M, Sallee F, Incledon B, Wilens T . Functional Impairment in Youth With ADHD: Normative Data and Norm-Referenced Cutoff Points for the Before School Functioning Questionnaire and the Parent Rating of Evening and Morning Behavior Scale, Revised. J Clin Psychiatry. 2019; 81(1). DOI: 10.4088/JCP.19m12956. View

13.

Wigal S, Wigal T, Childress A, Donnelly G, Reiz J . The Time Course of Effect of Multilayer-Release Methylphenidate Hydrochloride Capsules: A Randomized, Double-Blind Study of Adults With ADHD in a Simulated Adult Workplace Environment. J Atten Disord. 2016; 24(3):373-383. DOI: 10.1177/1087054716672335. View

14.

Wolraich M, Brown L, Brown R, DuPaul G, Earls M, Feldman H . ADHD: clinical practice guideline for the diagnosis, evaluation, and treatment of attention-deficit/hyperactivity disorder in children and adolescents. Pediatrics. 2011; 128(5):1007-22. PMC: 4500647. DOI: 10.1542/peds.2011-2654. View

15.

Fuermaier A, Tucha L, Butzbach M, Weisbrod M, Aschenbrenner S, Tucha O . ADHD at the workplace: ADHD symptoms, diagnostic status, and work-related functioning. J Neural Transm (Vienna). 2021; 128(7):1021-1031. PMC: 8295111. DOI: 10.1007/s00702-021-02309-z. View

16.

Wilens T, Faraone S, Hammerness P, Pliszka S, Uchida C, DeSousa N . Clinically Meaningful Improvements in Early Morning and Late Afternoon/Evening Functional Impairment in Children with ADHD Treated with Delayed-Release and Extended-Release Methylphenidate. J Atten Disord. 2021; 26(5):696-705. PMC: 8785267. DOI: 10.1177/10870547211020073. View

17.

Childress A, Cutler A, Po M, DeSousa N, Warrington L, Sallee F . Symptomatic and Functional Response and Remission From the Open-Label Treatment-Optimization Phase of a Study With DR/ER-MPH in Children With ADHD. J Clin Psychiatry. 2021; 82(4). DOI: 10.4088/JCP.21m13914. View

18.

Coghill D, Banaschewski T, Lecendreux M, Zuddas A, Dittmann R, Otero I . Efficacy of lisdexamfetamine dimesylate throughout the day in children and adolescents with attention-deficit/hyperactivity disorder: results from a randomized, controlled trial. Eur Child Adolesc Psychiatry. 2013; 23(2):61-8. PMC: 3918120. DOI: 10.1007/s00787-013-0421-y. View

19.

Storebo O, Ramstad E, Krogh H, Nilausen T, Skoog M, Holmskov M . Methylphenidate for children and adolescents with attention deficit hyperactivity disorder (ADHD). Cochrane Database Syst Rev. 2015; (11):CD009885. PMC: 8763351. DOI: 10.1002/14651858.CD009885.pub2. View

20.

Bernardi S, Faraone S, Cortese S, Kerridge B, Pallanti S, Wang S . The lifetime impact of attention deficit hyperactivity disorder: results from the National Epidemiologic Survey on Alcohol and Related Conditions (NESARC). Psychol Med. 2011; 42(4):875-87. PMC: 3383088. DOI: 10.1017/S003329171100153X. View