227
Views
2
CrossRef citations to date
0
Altmetric
Drug Profile

The use of modified-release methylphenidate in the treatment of attention-deficit/hyperactivity disorder

, &
Pages 113-121 | Received 28 Aug 2016, Accepted 09 Dec 2016, Published online: 24 Dec 2016

References

  • Visser SN, Danielson ML, Bitsko RH, et al. Trends in the parent-report of health care provider-diagnosed and medicated attention-deficit/hyperactivity disorder: United States, 2003-2011. J Am Acad Child Adolesc Psychiatry. 2014;53(1):34–46e32. ​​
  • Kessler RC, Adler L, Barkley R, et al. The prevalence and correlates of adult ADHD in the United States: results from the National Comorbidity Survey Replication. Am J Psychiatry. 2006;163(4):716–723.
  • Polanczyk GV, Salum GA, Sugaya LS, et al. Annual research review: a meta-analysis of the worldwide prevalence of mental disorders in children and adolescents. J Child Psychol Psychiatry. 2015;56(3):345–365.
  • Polanczyk G, De Lima MS, Horta BL, et al. The worldwide prevalence of ADHD: a systematic review and metaregression analysis. Am J Psychiatry. 2007;164(6):942–948.
  • Willcutt EG. The prevalence of DSM-IV attention-deficit/hyperactivity disorder: a meta-analytic review. Neurotherapeutics. 2012;9(3):490–499.
  • Ebejer JL, Medland SE, Van Der Werf J, et al. Attention deficit hyperactivity disorder in Australian adults: prevalence, persistence, conduct problems and disadvantage. PLoS One. 2012;7(10):e47404.
  • Kupper T, Haavik J, Drexler H, et al. The negative impact of attention-deficit/hyperactivity disorder on occupational health in adults and adolescents. Int Arch Occup Environ Health. 2012;85(8):837–847.
  • Arnsten AF. Toward a new understanding of attention-deficit hyperactivity disorder pathophysiology: an important role for prefrontal cortex dysfunction. CNS Drugs. 2009;23(Suppl 1):33–41.
  • Wolraich M, Brown L, Brown RT, et al. ADHD: clinical practice guideline for the diagnosis, evaluation, and treatment of attention-deficit/hyperactivity disorder in children and adolescents. Pediatrics. 2011;128(5):1007–1022.
  • Pliszka S. Practice parameter for the assessment and treatment of children and adolescents with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2007;46(7):894–921.
  • Ritalin hydrochloride® (methylphenidate hydrochrloride USP tablets) CII Prescribing Information. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/010187s080,018029s049,021284s027lbl.pdf [ cited 2016 August 28].
  • Pelham WE Jr., Sturges J, Hoza J, et al. Sustained release and standard methylphenidate effects on cognitive and social behavior in children with attention deficit disorder. Pediatrics. 1987;80(4):491–501.
  • HIGHLIGHTS OF PRESCRIBING INFORMATION. CONCERTA® (methylphenidate HCl) Extended-Release Tablets CII. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021121s035lbl.pdf [ cited 28 August 2016].
  • Armstrong RB, Damaraju CV, Ascher S, et al. Time course of treatment effect of OROS® methylphenidate in children with ADHD. J Atten Disord. 2012;16(8):697–705.
  • Silva R, Muniz R, Pestreich LK, et al. Efficacy of two long-acting methylphenidate formulations in children with attention-deficit/hyperactivity disorder in a laboratory classroom setting. J Child Adolesc Psychopharmacol. 2005;15(4):637–654.
  • Once Daily Metadate CD® (methylphenidate HCl, USP) Extended-Release Capsules CII Prescribing Information. Available from:http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021259s029lbl.pdf [ cited 28 August 2016].
  • Swanson JM, Wigal SB, Wigal T, et al. A comparison of once-daily extended-release methylphenidate formulations in children with attention-deficit/hyperactivity disorder in the laboratory school (the COMACS Study). Pediatrics. 2004;113(3 Pt 1):e206–216.
  • HIGHLIGHTS OF PRESCRIBING INFORMATION DAYTRANA® (methylphenidate transdermal system). Available from: http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021514s023lbl.pdf [ cited 28 August 2016].
  • McGough JJ, Wigal SB, Abikoff H, et al. A randomized, double-blind, placebo-controlled, laboratory classroom assessment of methylphenidate transdermal system in children with ADHD. J Atten Disord. 2006;9(3):476–485.
  • Pierce D, Dixon CM, Wigal SB, et al. Pharmacokinetics of methylphenidate transdermal system (MTS): results from a laboratory classroom study. J Child Adolesc Psychopharmacol. 2008;18(4):355–364.
  • HIGHLIGHTS OF PRESCRIBING INFORMATION QUILLIVANT XR® (methylphenidate hydrochloride) for extended-release oral suspension, CII Available from: http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202100s004lbl.pdf [ cited 28 August 2016].
  • Wigal SB, Childress AC, Belden HW, et al. NWP06, an extended-release oral suspension of methylphenidate, improved attention-deficit/hyperactivity disorder symptoms compared with placebo in a laboratory classroom study. J Child Adolesc Psychopharmacol. 2013;23(1):3–10.
  • HIGHLIGHTS OF PRESCRIBING INFORMATION QUILLICHEW ERTM (methylphenidate hydrochloride) extended-release chewable tablets, for oral use, CII. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207960s000lbl.pdf [ cited 28 August 2016].
  • HIGHLIGHTS OF PRESCRIBING INFORMATION APTENSIO XR™ (methylphenidate hydrochloride extended-release) Capsules, for oral use. CII. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205831s000lbl.pdf. [ cited 28 August 2016].
  • Clinical Review. Available from: http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/UCM449894.pdf [ cited 14 August 2016].
  • Adjei A, Kupper RJ, Teuscher NS, et al. Steady-state bioavailability of extended-release methylphenidate (MPH-MLR) capsule vs. immediate-release methylphenidate tablets in healthy adult volunteers. Clin Drug Investig. 2014;34(11):795–805.
  • Davids E, Zhang K, Tarazi FI, et al. Stereoselective effects of methylphenidate on motor hyperactivity in juvenile rats induced by neonatal 6-hydroxydopamine lesioning. Psychopharmacology (Berl). 2002;160(1):92–98.
  • Arnsten AF. Catecholamine influences on dorsolateral prefrontal cortical networks. Biol Psychiatry. 2011;69(12):e89–99.
  • Adjei A, Teuscher NS, Kupper RJ, et al. Single-dose pharmacokinetics of methylphenidate extended-release multiple layer beads administered as intact capsule or sprinkles versus methylphenidate immediate-release tablets (Ritalin(®)) in healthy adult volunteers. J Child Adolesc Psychopharmacol. 2014;24(10):570–578.
  • Reiz JL, Donnelly GA, Michalko K. Comparative bioavailability of single-dose methylphenidate from a multilayer-release bead formulation and an osmotic system: a two-way crossover study in healthy young adults. Clin Ther. 2008;30(1):59–69.
  • Quinn D, Bode T, Reiz JL, et al. Single-dose pharmacokinetics of multilayer-release methylphenidate and immediate-release methylphenidate in children with attention-deficit/hyperactivity disorder. J Clin Pharmacol. 2007;47(6):760–766.
  • Teuscher NS, Adjei A, Findling RL, et al. Population pharmacokinetics of methylphenidate hydrochloride extended-release multiple-layer beads in pediatric subjects with attention deficit hyperactivity disorder. Drug Des Devel Ther. 2015;9:2767–2775.
  • Weiss M, Hechtman L, Turgay A, et al. Once-daily multilayer-release methylphenidate in a double-blind, crossover comparison to immediate-release methylphenidate in children with attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2007;17(5):675–688.
  • Schachar R, Ickowicz A, Crosbie J, et al. Cognitive and behavioral effects of multilayer-release methylphenidate in the treatment of children with attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2008;18(1):11–24.
  • Wigal SB, Greenhill LL, Nordbrock E, et al. A randomized placebo-controlled double-blind study evaluating the time course of response to methylphenidate hydrochloride extended-release capsules in children with attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2014;24(10):562–569.
  • Wigal SB, Nordbrock E, Adjei AL, et al. Efficacy of methylphenidate hydrochloride extended-release capsules (Aptensio XR™) in children and adolescents with attention-deficit/hyperactivity disorder: a phase III, randomized, double-blind study.. CNS Drugs. 2015;29(4):331–340.
  • Jain U, Hechtman L, Weiss M, et al. Efficacy of a novel biphasic controlled-release methylphenidate formula in adults with attention-deficit/hyperactivity disorder: results of a double-blind, placebo-controlled crossover study. J Clin Psychiatry. 2007;68(2):268–277.
  • Guidance for Industry Assessment of Abuse Potential of Drugs Draft Guidance. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM198650.pdf [ cited 20 Oct 2016].
  • Top 25 Psychiatric Medication Prescriptions for 2013. Available from: http://psychcentral.com/lib/top-25-psychiatric-medication-prescriptions-for-2013/[ cited 14 Aug 2016].
  • Childress AC, Newcorn J, Stark JG, et al. A single-dose, single-period pharmacokinetic assessment of an extended-release orally disintegrating tablet of methylphenidate in children and adolescents with attention-deficit/hyperactivity disorder. J Adolesc Psychopharmacol. 2016;26:505–512.
  • Childress A, McDonnell MA, Kollins S, et al. Efficacy of HLD200 in a phase III analog classroom study in children with attention-deficit/hyperactivity disorder. Poster presented at the American Psychiatric Association 169th Annual Meeting, Atlanta, GA, (2016).
  • Wigal S, Wigal T, Childress A, et al., Double-blind study of the time-course of effect of multilayer release (MLR) methylphenidate in ADHD adults in a simulated adult workplace environment. Poster presented at the American Psychiatric Association 169th Annual Meeting, Atlanta, GA, (2016).
  • Quinn D, Bode T, DeSousa NJ, et al. A Phase-2 Pharmacokinetic Study of a Modified Release Formulation of Dextroamphetamine Following Evening Administration to Adolescents and Children with ADHD. Poster presented at the American Professional Society of ADHD and Related Disorders Annual Meeting, Washington, D.C. (2015).
  • Spencer TJ, Adler LA, Weisler RH, et al. Triple-bead mixed amphetamine salts (SPD465), a novel, enhanced extended-release amphetamine formulation for the treatment of adults with ADHD: a randomized, double-blind, multicenter, placebo-controlled study. J Clin Psychiatry. 2008;69(9):1437–1448.
  • Noven Announces Positive Phase 2 Results of Investigational d-Amphetamine Transdermal System for ADHD. [cited 2016 Dec 17]. Available from: http://www.noven.com/PR072213.php.
  • Hopkins SC, Sunkaraneni S, Skende E et al. A population-based PK/PD analysis of dasotraline in the treatment of ADHD in adults. Poster presented at the American Psychiatric Association Annual Meeting, Toronto, Canada, (2015).
  • Koblan KS, Hopkins SC, Sarma K, et al. Dasotraline for the treatment of attention-deficit/hyperactivity disorder: a randomized, double-blind, placebo-controlled, proof-of-concept trial in adults. Neuropsychopharmacology. 2015;40(12):2745–2752.
  • Robertson BA, Schram MJ, Schoedel KA, et al. Early stage assessment of the abuse potential of centanafadine, a triple reuptake inhibitor: preclinical and clincial study results. Poster presented at the American College of Neruopsychopharmacology 53rd Annual Meeting, Phoenix, AZ, (2014).
  • Wilens TE, Cutler AJ, Childress A, et al. A pilot study of a novel monoamine triple reuptake inhibitor, EB-1020 SR, in the treatment of attention-deficit/hyperactivity disorder in adult males. Poster presented at the Society of Biological Psychiatry Annual Meeting. New York, NY, (2014).
  • Manor I, Newcorn JH, Faraone SV, et al. Efficacy of metadoxine extended release in patients with predominantly inattentive subtype attention-deficit/hyperactivity disorder. Postgrad Med. 2013;125(4):181–190.
  • Manor I, Ben-Hayun R, Aharon-Peretz J, et al. A randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy, safety, and tolerability of extended-release metadoxine in adults with attention-deficit/hyperactivity disorder. J Clin Psychiatry. 2012;73(12):1517–1523.
  • Oka M, Itoh Y, Tatsumi S, et al. A novel cognition enhancer NS-105 modulates adenylate cyclase activity through metabotropic glutamate receptors in primary neuronal culture. Naunyn Schmiedebergs Arch Pharmacol. 1997;356(2):189–196.
  • Jones G, Dejesus-Rosario N, Ambrosini A, et al. Exploratory dose-escalation study of NFC-1 in ADHD adolescents with glutamatergic gene network variants. In: Poster presented at the American Academy of Child and Adolescent Psychiatry 62nd Annual Meeting, San Antonio, TX, (2015).
  • Elia J, Glessner JT, Wang K, et al. Genome-wide copy number variation study associates metabotropic glutamate receptor gene networks with attention deficit hyperactivity disorder. Nat Genet. 2012;44(1):78–84.
  • Connolly JJ, Glessner JT, Elia J, et al. ADHD & pharmacotherapy: past, present and future: a review of the changing landscape of drug therapy for attention deficit hyperactivity disorder. Ther Innov Regul Sci. 2015;49(5):632–642.
  • Nelson MR, Wegmann D, Ehm MG, et al. An abundance of rare functional variants in 202 drug target genes sequenced in 14,002 people. Science. 2012;337(6090):100–104.
  • Adriani W, Leo D, Guarino M, et al. Short-term effects of adolescent methylphenidate exposure on brain striatal gene expression and sexual/endocrine parameters in male rats. Ann N Y Acad Sci. 2006;1074:52–73.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.