Single-dose pharmacokinetics of NWP06, an extended-release methylphenidate suspension, in children and adolescents with ADHD

Postgraduate Medicine

Volumn 123, Issue 5, 2011, Pages 80-88

  Childress, Ann C ^a   Randy Sallee, F ^b   Berry, Sally A ^c  

^a Center for Psychiatry and Behavioral Medicine   (United States)

^b UNIVERSITY OF CINCINNATI COLLEGE OF MEDICINE   (United States)

^c NextWave Pharmaceuticals   (United States)

Author keywords

Attention deficit hyperactivity disorder; Extended release preparations; Methylphenidate; Pediatrics; Pharmacokinetics; QUILLIVANT

Indexed keywords

METHYLPHENIDATE; NWP 06; QUILLIVANT; UNCLASSIFIED DRUG;

ADOLESCENT; AGE; AREA UNDER THE CURVE; ARTICLE; ATTENTION DEFICIT DISORDER; BODY MASS; CHILD; CHILD HEALTH CARE; CLINICAL ARTICLE; CONTROLLED STUDY; DOSE RESPONSE; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DOSE COMPARISON; DRUG ELIMINATION; DRUG FORMULATION; DRUG HALF LIFE; DRUG SAFETY; DRUG TOLERABILITY; EPISTAXIS; FEMALE; GASTROINTESTINAL DISEASE; HUMAN; MALE; MAXIMUM PLASMA CONCENTRATION; MEDIASTINUM DISEASE; NEUROLOGIC DISEASE; PRESYNCOPE; RESPIRATORY TRACT DISEASE; SCHOOL CHILD; SINGLE DRUG DOSE; SUSPENSION; THORAX DISEASE; VOMITING;

ADOLESCENT; ATTENTION DEFICIT DISORDER WITH HYPERACTIVITY; CENTRAL NERVOUS SYSTEM STIMULANTS; CHILD; DELAYED-ACTION PREPARATIONS; DOSE-RESPONSE RELATIONSHIP, DRUG; HUMANS; MALE; METHYLPHENIDATE;

EID: 80052708242     PISSN: 00325481     EISSN: 19419260     Source Type: Journal    
DOI: 10.3810/pgm.2011.09.2462     Document Type: Article

References (32)

1. Merikangas KR, He JP, Brody D, Fischer PW, Bourdon K, Koretz DS. Prevalence and treatment of mental disorders among US children in the 2001-2004. NHANES. Pediatrics. 2010;125(1):75-81.
2. Pastor PN, Reuben CA. Diagnosed attention deficit hyperactivity disorder and learning disability: United States, 2004-2006. Vital Health Stat 10. 2008;237:1-14.
3. Castle L, Aubert RE, Verbrugge RR, Khalid M, Epstein RS. Trends in medication treatment for ADHD. J Atten Disord. 2007;10(4): 335-342.
4. Centers for Disease Control and Prevention (CDC). MMWR Morb Mortal Wkly Rep. 2010;59(44):1439-1443.
5. Pliszka S; 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(7):894-921.
6. Danckaerts M, Sonuga-Barke EJ, Banaschewski T, et al. The quality of life of children with attention deficit/hyperactivity disorder: a systematic review. Eur Child Adolesc Psychiatry. 2010;19(2):83-105.
7. Greydanus DE, Nazeer A, Patel DR. Psychopharmacology of ADHD in pediatrics: current advances and issues. Neuropsychiatr Dis Treat. 2009;5:171-181.
8. Kimko HC, Cross JT, Abernethy DR. Pharmacokinetics and clinical effectiveness of methylphenidate. Clin Pharmacokinet. 1999;37(6):457-470.
9. Modi NB, Lindemulder B, Gupta S. Single- and multiple-dose pharmacokinetics of oral once-a-day osmotic controlled-release OROS (methylphenidate HCL) formulation. J Clin Pharmacol. 2000;40(4):379-388.
10. Shaywitz SE, Hunt RD, Jatlow P, et al. Psychopharmacology of attention deficit disorder: pharmacokinetic, neuroendocrine, and behavioral measures following acute and chronic treatment with methylphenidate. Pediatrics. 1982;69(6):688-694.
11. Swanson J, Gupta S, Lam A, et al. Development of a new once-a-day formulation of methylphenidate for the treatment of attention-deficit/ hyperactivity disorder: proof-of-concept and proof-of-product studies. Arch Gen Psychiatry. 2003;60(2):204-211.
12. Lyseng-Williamson KA, Keating GM. Extended-release methylphenidate (Ritalin LA). Drugs. 2002;62(15):2251-2259.
13. Childress AC, Spencer T, Lopez F, et al. Efficacy and safety of dexmethylphenidate extended-release capsules administered once daily to children with attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2009;19(4):351-361.
14. Pentikis HS, Simmons RD, Benedict MF, Hatch SJ. Methylphenidate bioavailability in adults when an extended-release multiparticulate formulation is administered sprinkled on food or as an intact capsule. J Am Acad Child Adolesc Psychiatry. 2002;41(4):443-449.
15. 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(6):684-691.
16. Boellner SW, Stark JG, Krishnan S, Zhang Y. Pharmacokinetics of lisdexamfetamine dimesylate and its active metabolite, d-amphetamine, with increasing oral doses of lisdexamfetamine dimesylate in children with attention-deficit/hyperactivity disorder: a single-dose, randomized, open-label, crossover study. Clin Ther. 2010;32(2):252-264.
17. Banaschewski T, Coghill D, Santosh P, et al. Long-acting medications for the hyperkinetic disorders. A systematic review and European treatment guideline. Eur Child Adolesc Psychiatry. 2006;115(8):476-495.
18. Meltzer EO, Welch MJ, Ostrom NK. Pill swallowing ability and training in children 6 to 11 years of age. Clin Pediatr (Phila). 2006;45(8):725-733.
19. Findling RL, Wigal SB, Bukstein OG, et al. Long-term tolerability of the methylphenidate transdermal system in pediatric attention-deficit/hyperactivity disorder: a multicenter, prospective, 12-month, open-label, uncontrolled, phase III extension of four clinical trials. Clin Ther. 2009;31(8):1844-1855.
20. Schirm E, Tobi H, de Vries TW, Choonara I, De Jong-van den Berg LT. Lack of appropriate formulations of medicines for children in the community. Acta Paediatr. 2003;92(12):1486-1489.
21. Num AJ. Making medicines that children can take. Arch Dis Child. 2003;88:369-371.
22. Conroy S. Unlicensed and off-label drug use: issues and recommen dations. Paediatr Drugs. 2002;4(6):353-359.
23. Adler LD, Nierenberg AA. Review of medication adherence in children and adults with ADHD. Postgrad Med. 2010;122(1):184-191.
24. Childress AC, Berry SA. The single-dose pharmacokinetics of NWP06, a novel extended-release methylphenidate oral suspension. Postgrad Med. 2010;122(5):35-41.
25. Patrick KS, Straughn AB, Jarvi EJ, Breese GR, Meyer MC. The absorption of sustained-release methylphenidate formulations compared to an immediate-release formulation. Biopharm Drug Dispos. 1989;10(2):165-171.
26. Dopheide JA. The role of pharmacotherapy and managed care pharmacy interventions in the treatment of ADHD. Am J Manag Care. 2009;15(5 suppl):S141-S150.
27. Concerta (methylphenidate hydrochloride) tablets [package insert]. Titusville, NJ: McNeil Pediatrics; 2010.
28. Daytrana (methylphenidate) film, extended release transdermal [package insert]; Wayne, PA: Shire Pharmaceuticals Inc; 2010.
29. Mennella JA, Beauchamp GK. Optimizing oral medications for children. Clin Ther. 2008;30(11):2120-2132.
30. Beck MH, Cataldo M, Slifer KJ, Pulbrook V, Guhman JK. Teaching children with attention deficit hyperactivity disorder (ADHD) and autistic disorder (AD) how to swallow pills. Clin Pediatr (Phila). 2005;44(6):515-526.
31. Bokhari FAS, Heiland F, Levine P, Ray GT. Risk factors for discontinuing drug therapy among children with ADHD. Health Serv Outcomes Res Method. 2008;8:134-158.
32. Greenhill LL, Halperin JM, Abikoff H. Stimulant medications. J Am Acad Child Adolesc Psychiatry. 1999;38(5):503-512.