Lisdexamfetamine dimesylate: A prodrug stimulant for the treatment of ADHD in children and adults

CNS Spectrums

Volumn 15, Issue 5, 2010, Pages 315-325

  Mattingly, Gregory ^a  

^a WASHINGTON UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CARBON 14; DEXAMPHETAMINE; LISDEXAMFETAMINE; LONG ACTING DRUG; OMEPRAZOLE; PLACEBO; PRODRUG;

ABDOMINAL PAIN; ANOREXIA; ANXIETY; APPETITE; ATTENTION DEFICIT DISORDER; CLINICAL TRIAL; DIARRHEA; DIASTOLIC BLOOD PRESSURE; DOSE RESPONSE; DOSE TIME EFFECT RELATION; DRUG ABSORPTION; DRUG ABUSE; DRUG BLOOD LEVEL; DRUG DELIVERY SYSTEM; DRUG DOSE COMPARISON; DRUG DOSE ESCALATION; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG ELIMINATION; DRUG FORMULATION; DRUG HALF LIFE; DRUG INDUCED HEADACHE; DRUG MECHANISM; DRUG POTENTIATION; DRUG SAFETY; DRUG STRUCTURE; DRUG TOLERABILITY; ENZYME INHIBITION; FEELING JITTERY; HEART RATE VARIABILITY; HUMAN; INSOMNIA; IRRITABILITY; ISOTOPE LABELING; MAXIMUM PLASMA CONCENTRATION; NAUSEA; PRIORITY JOURNAL; RADIOACTIVITY; REVIEW; SIDE EFFECT; SINGLE DRUG DOSE; SLEEP PARAMETERS; SLEEP QUALITY; SYSTOLIC BLOOD PRESSURE; UPPER RESPIRATORY TRACT INFECTION; VOMITING; WEIGHT REDUCTION; XEROSTOMIA;

EID: 77952562632     PISSN: 10928529     EISSN: None     Source Type: Journal    
DOI: 10.1017/S1092852900027541     Document Type: Review

References (51)

1. Faraone SV. Etiology and pathophysiology of adult attention-deficit/hyperactivity disorder. Primary Psychiatry. 2004;11:28-40.
2. Pliszka S, Bernet W, Bukstein O, et al. AACAP Work Group on Quality Issues. Practice parameter for the assessment and treatment of children and adolescents with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2007;46:894-921.
3. Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision. Arlington, VA: American Psychiatric Association; 2000.
4. Faraone SV, Perlis RH, Doyle AE, et al. Molecular genetics of attention-deficit/hyperactivity disorder. Biol Psychiatry. 2005;57:1313-1323.
5. Spencer TJ. Mixed amphetamine salts extended release for the treatment of ADHD in adolescents: current evidence. CNS Spectr. 2005;10(suppl 15):5.
6. Dulcan M, Dunne JE, Ayres W, et al. Work Group on Quality Issues. Practice parameters for the assessment and treatment of children, adolescents, and adults with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 1997;36(suppl 10):85S-121S.
7. Kessler RC, Adler L, Ames M, et al. The World Health Organization adult ADHD self-report scale (ASRS): a short screening scale for use in the general population. Psychol Med. 2005;35:245-256.
8. Adler L, Cohen J. Diagnosis and evaluation of adults with attention-deficit/hyperactivity disorder. Psychiatr Clin North Am. 2004;27:187-201.
9. 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;163:716-723.
10. Shaw P, Eckstrand K, Sharp W, et al. Attention-deficit/hyperactivity disorder is characterized by a delay in cortical maturation. Proc Natl Acad Sci. 2007;104:19649-19654.
11. Pelham WE, Gnagy EM, Burrows-Maclean L, et al. Once-a-day Concerta methylphenidate versus three-times-daily methylphenidate in laboratory and natural settings. Pediatrics. 2001;107:e105-e119.
12. Biederman J, Lopez FA, Boellner SW, Chandler MC. A randomized, double-blind, placebo-controlled, parallel-group study of SLI381 (Adderall XR) in children with attention-deficit/hyperactivity disorder. Pediatrics. 2002;110:258-266.
13. Vyvanse (lisdexamfetamine dimesylate) capsules [package insert]. Wayne, PA: Shire US Inc; 2009.
14. Krishnan S, Zhang Y. Relative bioavailability of lisdexamfetamine 70-mg capsules in fasted and fed healthy adult volunteers and in solution: a single-dose, crossover pharmacokinetic study. J Clin Pharmacol. 2008;48:293-302.
15. Pennick M. Hydrolytic conversion of lisdexamfetamine dimesylate to the active moiety, d-amphetamine. Presented at: Society of Biological Psychiatry Annual Scientific Convention and Meeting; May 14-16, 2009; Vancouver, British Columbia, Canada.
16. Pennick M. Absorption of lisdexamfetamine dimesylate and hydrolysis to form the active moiety, d-amphetamine. Poster presented at: Annual Meeting of the New Clinical Drug Evaluation Unit; June 29-July 2, 2009; Hollywood, FL.
17. Krishnan SM, Pennick M, Stark JG. Metabolism, distribution and elimination of lisdexamfetamine dimesylate: open-label, single-centre, phase I study in healthy adult volunteers. Clin Drug Invest. 2008;28:745-755.
18. Shojaei A, Ermer JC, Krishnan S. Lisdexamfetamine dimesylate as a treatment for ADHD: dosage formulation and pH effects. Presented at: American Psychiatric Association Annual Meeting; May 19-24, 2007; San Diego, CA. Poster NR740.
19. Markowitz JS, Straughn AB, Patrick KS. Advances in the pharmacotherapy of attention-deficit-hyperactivity disorder: focus on methylphenidate formulations. Pharmacotherapy. 2003;23(10):1281-1299.
20. Adderall XR (mixed salts of a single-entity amphetamine product) capsules [package insert]. Wayne, PA: Shire US Inc; 2009.
21. Haffey M, Buckwalter M, Zhang P, et al. Effects of omeprazole on the pharmacokinetic profiles of lisdexamfetamine dimesylate and extended-release mixed amphetamine salts in adults. Postgrad Med. 2009;121:11-19.
22. Krishnan S, Moncrief S, Ermer JC. Lisdexamfetamine dimesylate (NRP104)-GLP in vitro human cytochrome P450 inhibitory drug-drug interaction study. Presented at: 61st Annual Convention and Scientific Program of the Society of Biological Psychiatry; May 20, 2006; Toronto, Canada.
23. Biederman J, Boellner SW, Childress A, Lopez FA, Krishnan S, Zhang Y. Lisdexamfetamine dimesylate and mixed amphetamine salts extended-release in children with ADHD: a double-blind, placebo-controlled, crossover analog classroom study. Biol Psychiatry. 2007;62:970-976.
24. Ermer JC, Shojaei AH, Biederman J, Krishnan S. Improved interpatient pharmacokinetic variability of lisdexamfetamine dimesylate compared with mixed amphetamine salts extended release in children aged 6 to 12 years with attention-deficit/hyperactivity disorder. Presented at: American Psychiatric Association Annual Meeting; May 19-24, 2007; San Diego, CA. Poster NR750.
25. Ermer J, Homolka R, Martin P, Buckwalter M, Purkayastha J, Roesch BG. Linear dose proportionality, low inter- and intrasubject variability, and safety of lisdexamfetamine dimesylate in an open-label single-dose pharmacokinetic study in healthy adult volunteers. Presented at: American College of Clinical Pharmacy Annual Meeting; October 19-22, 2008; Louisville, KY. Poster 201.
26. Biederman J, Krishnan S, Zhang Y, McGough JJ, Findling RL. Efficacy and tolerability of lisdexamfetamine dimesylate (NRP-104) in children with attention-deficit/hyperactivity disorder: a phase III, multicenter, randomized, double-blind, forced-dose, parallel-group study. Clin Ther. 2007;29:450-463.
27. Wigal SB, Kollins SH, Childress AC, Squires LA. A 13-hour laboratory school study of lisdexamfetamine dimesylate in school-aged children with attention-deficit/hyperactivity disorder. Child Adolesc Psychiatry Ment Health. 2009;3:17.
28. Findling RL, Childress AC, Krishnan S, McGough JJ. Long-term effectiveness and safety of lisdexamfetamine dimesylate in school-aged children with attention-deficit/hyperactivity disorder. CNS Spectr. 2008;13:614-620.
29. Findling R, Jain R, Gao J, Richards C, Ginsberg L. A dose-optimization study of the efficacy, safety, and tolerability of lisdexamfetamine dimesylate in children aged 6 to 12 years with attention-deficit/hyperactivity disorder. Presented at: American Academy of Child and Adolescent Psychiatry Annual Meeting; October 28-November 2, 2008; Chicago, IL. Poster 1.10.
30. Adler LA, Goodman DW, Kollins SH, et al. 303 Study Group. Double-blind, placebo-controlled study of the efficacy and safety of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder. J Clin Psychiatry. 2008;69:1364-1373.
31. Brams M. Efficacy and safety of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder in the adult workplace environment. Presented at: Annual Meeting of the New Clinical Drug Evaluation Unit; June 29-July 2, 2009; Hollywood, FL.
32. Weisler R, Young J, Mattingly G, Gao J, Squires L, Adler L; on behalf of the 304 Study Group. Long-term safety and effectiveness of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder. CNS Spectr. 2009;14:573-585.
33. Wigal SB, Gupta S, Guinta D, Swanson JM. Reliability and validity of the SKAMP rating scale in a laboratory school setting. Psychopharmacol Bull. 1998;34:47-53.
34. Swanson J, Wigal S, Greenhill L, et al. Objective and subjective measures of the pharmacodynamic effects of Adderall in the treatment of children with ADHD in a controlled laboratory classroom setting. Psychopharmacol Bull. 1998;34:55-60.
35. Guy W, ed. ECDEU Assessment Manual for Psychopharmacology Revised. Rockville, MD: National Institute of Mental Health; DHEW publication no. ADM 76-338; 1976:218-222.
36. Lopez FA, Childress AC, Curtiss S. Improvement in attention-deficit/hyperactivity disorder symptoms in children with lisdexamfetamine dimesylate versus extended-release mixed amphetamine salts and placebo in an analog classroom. Presented at: American College of Clinical Pharmacy Annual Meeting; October 19-22, 2008; Louisville, KY. Poster 206E.
37. Scheckner B, Schreckengost J, Favit A. Physician perception of clinical improvement with lisdexamfetamine dimesylate in children aged 6 to 12 years with attention-deficit/hyperactivity disorder. Presented at: American Psychiatric Association Annual Meeting; May 3-8, 2008; Washington, DC. Poster NR6-003.
38. DuPaul GJ, Power TJ, Anastopoulos AD, Reid R. ADHD Rating Scale-IV: Checklists, Norms, and Clinical Interpretations. New York, NY: Guilford Press; 1998.
39. Conners CK, Sitarenios G, Parker JDA, Epstein JN. The revised Conners' Parent Rating Scale (CPRS-R): factor structure, reliability, and criterion validity. J Abnorm Child Psychol. 1998;26:257-268.
40. Faraone SV, Schreckengost J. Lisdexamfetamine dimesylate effect size in children with attention-deficit/hyperactivity disorder. Presented at: American Academy of Child & Adolescent Psychiatry Annual Meeting; October 23-28, 2007; Boston, MA. Poster E58.
41. Mares D, McLuckie A, Schwartz M, Saini M. Executive function impairments in children with attention-deficit hyperactivity disorder: do they differ between school and home environments? Can J Psychiatry. 2007;52:527-534.
42. Strine TW, Lesesne CA, Okoro CA, et al. Emotional and behavioral difficulties and impairments in everyday functioning among children with a history of attention-deficit/hyperactivity disorder. Prev Chronic Dis. 2006;3:A52.
43. Perwien AR, Kratochvil CJ, Faries D, et al. Emotional expression in children treated with ADHD medication: development of a new measure. J Atten Disord. 2008;11:568-579.
44. Gioia GA, Isquith PK, Retzlaff PD, Espy KA. Confirmatory factor analysis of the Behavior Rating Inventory of Executive Function (BRIEF) in a clinical sample. Child Neuropsychol. 2002;8:249-257.
45. Adler LA, Goodman D, Weisler R, Hamdani M, Roth T. Effect of lisdexamfetamine dimesylate on sleep in adults with attention-deficit/hyperactivity disorder. Behav Brain Funct. 2009;5:34.
46. Favit A, Schreckengost J, Richards C. Efficacy and safety of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder and a history of depression. Presented at: American Psychiatric Association Annual Meeting; May 3-8, 2008; Washington, DC. Poster NR6-002.
47. Upadhyaya H, Schreckengost J, Youcha S. Efficacy and safety of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder and a history of substance use disorder. Presented at: American Psychiatric Association Annual Meeting; May 3-8, 2008; Washington, DC. Poster NR6-015.
48. Childress AC, Wigal SB, Greenbaum M, Biederman J. Efficacy and safety of lisdexamfetamine dimesylate in the treatment of female children and adults with attention-deficit/hyperactivity disorder. Presented at: American Psychiatric Association Annual Meeting; May 3-8, 2008; Washington, DC. Poster NR6-001.
49. Niebler G, Wilens TE, Weisler R, Goodman D, Adler L, Biederman J. Evaluation of cardiovascular effects of lisdexamfetamine dimesylate treatment in adults with attention-deficit/hyperactivity disorder. Presented at: American Psychiatric Association Annual Meeting; May 3-8, 2008; Washington, DC. Poster NR6-013.
50. Jasinski DR, Krishnan S. Human pharmacology of intravenous lisdexamfetamine dimesylate: abuse liability in adult stimulant abusers. J Psychopharmacol. 2009;23:410-418.
51. Jasinski DR, Krishnan S. Abuse liability and safety of oral lisdexamfetamine dimesylate in individuals with a history of stimulant abuse. J Psychopharmacol. 2009;23:419-427.