396
Views
14
CrossRef citations to date
0
Altmetric
Clinical Focus: Neurological and Psychiatric Disorders - Original Research

A randomized crossover study to assess the pharmacokinetics of a novel amphetamine extended-release orally disintegrating tablet in healthy adults

, , &
Pages 648-655 | Received 13 Jun 2016, Accepted 21 Jul 2016, Published online: 11 Aug 2016

References

  • Rabito-Alcon MF, Correas-Lauffer J. Treatment guidelines for Attention Deficit and Hyperactivity Disorder: a critical review. Actas Esp Psiquiatr. 2014;42:315–324.
  • Felt BT, Biermann B, Christner JG, et al. Diagnosis and management of ADHD in children. Am Fam Physician. 2014;90:456–464.
  • Coghill D, Banaschewski T, Zuddas A, et al. Long-acting methylphenidate formulations in the treatment of attention-deficit/hyperactivity disorder: a systematic review of head-to-head studies. BMC Psychiatry. 2013;13:237.
  • Antshel KM, Hargrave TM, Simonescu M, et al. Advances in understanding and treating ADHD. BMC Med. 2011;9:72.
  • Kaiser Permanente National Guideline Summary for Child/Adolescent Attention-Deficit/Hyperactivity Disorder. Kaiser Permanente Medical Care Program; 2012 [cited 2015 Jul 8]. Available from: https://providers.kaiserpermanente.org/info_assets/cpp_oh/oh_adhd_national_guideline_summary_03_22_1012.pdf.
  • Chavez B, Sopko MA Jr, Ehret MJ, et al. An update on central nervous system stimulant formulations in children and adolescents with attention-deficit/hyperactivity disorder. Ann Pharmacother. 2009;43:1084–1095.
  • McGough JJ, Biederman J, Greenhill LL, et al. Pharmacokinetics of SLI381 (ADDERALL XR), an extended-release formulation of Adderall. J Am Acad Child Adolesc Psychiatry. 2003;42:684–691.
  • Feldman M, Belanger S. Extended-release medications for children and adolescents with attention-deficit hyperactivity disorder. Paediatr Child Health. 2009;14:593–602.
  • Subcommittee on Attention-Deficit/Hyperactivity Disorder, Steering Committee on Quality Improvement and Management, Wolraich M, et al. ADHD: Clinical practice guideline for the diagnosis, evaluation, and treatment of attention-deficit/hyperactivity disorder in children and adolescents. Pediatrics. 2011;128:1007–1022.
  • Fellner C. Pharmaceutical approval update. P T. 2016;41:162–163.
  • Childress A, Tran C. Current investigational drugs for the treatment of attention-deficit/hyperactivity disorder. Expert Opin Investig Drugs. 2016;25:463–474.
  • Neos therapeutics. Adzenys™ XR-ODT [Full Prescribing Information]. Grand Prairie (TX): Neos Therapeutics; 2016.
  • Nagar P, Singh K, Chauhan I, et al. Orally disintegrating tablets: formulation, preparation techniques and evaluation. JAPS. 2011;1:35–45.
  • Saharan VA, Singh A. Fast dissolving/disintegrating dosage forms: growth from immediate release to sustained release and traditional medicines. Recent Pat Drug Deliv Formul. 2015;9(3):189–191.
  • Childress AC, Kollins SH, Cutler AJ, et al. Efficacy, safety, and tolerability of an extended-release orally disintegrating methylphenidate tablet in children 6–12 years of age with attention-deficit/hyperactivity disorder in the laboratory classroom setting. J Child Adolesc Psychopharmacol. 2016 May 16. [Epub ahead of print].
  • Childress A, 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 Child Adolesc Psychopharmacol. 2016 May 16. [Epub ahead of print].
  • WMA. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013;310:2191–2194.
  • ICH Harmonised Tripartite Guideline: Guideline for good clinical practice E6. International Conference on Harmonisation; 1996 [cited 2015 Jul 14]. Available from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf.
  • Shire. Adderall XR® [Full Prescribing Information]. Wayne (PA): Shire; 2015.
  • Food and Drug Administration. Guidance for industry: food-effect bioavailability and fed bioequivalence studies; recommended; 2002 [cited 2015 Jul 14]. Available from: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126833.pdf
  • Posner KBD, Lucas C, Gould M, et al. Columbia-Suicide Severity Rating Scale (C-SSRS) baseline version. The Research Foundation for Mental Hygiene, Inc.; 2009 [cited 2015 Jul 14]. Available from: http://cssrs.columbia.edu/docs/C-SSRS_1_14_09_Baseline.pdf.
  • Food and Drug Administration. Draft guidance on amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate; recommended; 2012 [cited 2015 Jul 14]. Available from: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm319975.pdf
  • Posner KBD, Lucas C, Gould M et al. Columbia-Suicide Severity Rating Scale (C-SSRS) The Research Foundation for Mental Hygiene, Inc.; 2008 [cited 2015 Jul 14]. Available from: http://www.integration.samhsa.gov/clinical-practice/Columbia_Suicide_Severity_Rating_Scale.pdf
  • Food and Drug Administration. Statistical approaches to establishing bioequivalence; recommended; 2001 [cited 2015 Jul 14]. Available from: http://www.fda.gov/downloads/Drugs/…/Guidances/ucm070244.pdf
  • Kooij SJ, Bejerot S, Blackwell A, et al. European consensus statement on diagnosis and treatment of adult ADHD: The European Network Adult ADHD. BMC Psychiatry. 2010;10:67.
  • Buitelaar J, Medori R. Treating attention-deficit/hyperactivity disorder beyond symptom control alone in children and adolescents: a review of the potential benefits of long-acting stimulants. Eur Child Adolesc Psychiatry. 2010;19:325–340.
  • López FA, Leroux JR. Long-acting stimulants for treatment of attention-deficit/hyperactivity disorder: a focus on extended-release formulations and the prodrug lisdexamfetamine dimesylate to address continuing clinical challenges. Atten Defic Hyperact Disord. 2013;5:249–265.
  • Food and Drug Administration. Guidence for industry: applications covered by section 505(b)(2); recommended; 1999 [cited 2015 Jul 14]. Available from: http://www.fda.gov/downloads/Drugs/…/Guidances/ucm079345.pdf
  • McKeage K, Scott LJ, SLI-381 (Adderall XR). CNS Drugs. 2003;17:669–775; discussion 76–77
  • Spencer TJ, Wilens TE, Biederman J, et al. Efficacy and safety of mixed amphetamine salts extended release (Adderall XR) in the management of attention-deficit/hyperactivity disorder in adolescent patients: a 4-week, randomized, double-blind, placebo-controlled, parallel-group study. Clin Ther. 2006;28:266–279.
  • Heal DJ, Smith SL, Gosden J, et al. Amphetamine, past and present–a pharmacological and clinical perspective. J Psychopharmacol. 2013;27:479–496.

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.