The US Food and Drug Administration's perspective on the new antidepressant vortioxetine

Journal of Clinical Psychiatry

Volumn 76, Issue 1, 2015, Pages 8-14

  Zhang, Jing ^a   Mathis, Mitchell V ^a   Sellers, Jenn W ^a   Kordzakhia, George ^a   Jackson, Andre J ^a   Dow, Antonia ^a   Yang, Peiling ^a   Fossom, Linda ^a   Zhu, Hao ^a   Patel, Hiren ^a   Unger, Ellis F ^a   Temple, Robert J ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AMFEBUTAMONE; ANTIDEPRESSANT AGENT; CYTOCHROME P450 2D6; DULOXETINE; PLACEBO; RIFAMPICIN; SEROTONIN UPTAKE INHIBITOR; VENLAFAXINE; VORTIOXETINE; PIPERAZINE DERIVATIVE; SULFIDE;

AGE; ARTICLE; CONSTIPATION; DATA ANALYSIS; DOSE RESPONSE; DRUG APPROVAL; DRUG CLEARANCE; DRUG DOSE INCREASE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG HALF LIFE; DRUG LABELING; DRUG MECHANISM; DRUG METABOLISM; DRUG RESPONSE; DRUG SAFETY; DRUG WITHDRAWAL; FOOD AND DRUG ADMINISTRATION; GENDER; GENERALIZED ANXIETY DISORDER; HUMAN; KIDNEY FAILURE; MAINTENANCE DRUG DOSE; MAJOR DEPRESSION; MILD HEPATIC IMPAIRMENT; MODERATE HEPATIC IMPAIRMENT; NAUSEA; PRIORITY JOURNAL; SEXUAL DYSFUNCTION; TIME TO MAXIMUM PLASMA CONCENTRATION; VOMITING; ADULT; ANXIETY DISORDERS; CONTROLLED CLINICAL TRIAL (TOPIC); DEPRESSIVE DISORDER, MAJOR; FEMALE; MALE; MIDDLE AGED; STANDARDS; UNITED STATES;

ADULT; ANXIETY DISORDERS; CONTROLLED CLINICAL TRIALS AS TOPIC; DEPRESSIVE DISORDER, MAJOR; DRUG APPROVAL; FEMALE; HUMANS; MALE; MIDDLE AGED; PIPERAZINES; SEROTONIN UPTAKE INHIBITORS; SULFIDES; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84925356830     PISSN: 01606689     EISSN: None     Source Type: Journal    
DOI: 10.4088/JCP.14r09164     Document Type: Article

References (21)

1. US Food and Drug Administration. Drug Approval Package. Brintellix (Vortioxetine) tablets. http://www.accessdata.fda.gov/drugsatfda-docs/nda/2013/204447Orig1s000TOC.cfm. Updated October 30, 2013. Accessed August 18, 2014.
2. Mahableshwarkar AR, Jacobsen PL, Chen Y. A randomized, double-blind trial of 2.5mg and 5mg vortioxetine (Lu AA21004) versus placebo for 8 weeks in adults with major depressive disorder. Curr Med Res Opin. 2013;29(3):217-226.
3. Jain R, Mahableshwarkar AR, Jacobsen PL, et al. A randomized, double-blind, placebo-controlled 6-wk trial of the efficacy and tolerability of 5 mg vortioxetine in adults with major depressive disorder. Int J Neuropsychopharmacol. 2013;16(2):313-321.
4. Henigsberg N, Mahableshwarkar AR, Jacobsen P, et al. A randomized, double-blind, placebo-controlled 8-week trial of the efficacy and tolerability of multiple doses of Lu AA21004 in adults with major depressive disorder. J Clin Psychiatry. 2012;73(7):953-959.
5. Katona C, Hansen T, Olsen CK. A randomized, double-blind, placebo-controlled, duloxetine-referenced, fixed-dose study comparing the efficacy and safety of Lu AA21004 in elderly patients with major depressive disorder. Int Clin Psychopharmacol. 2012;27(4):215-223.
6. Boulenger JP, Loft H, Florea I. A randomized clinical study of Lu AA21004 in the prevention of relapse in patients with major depressive disorder. J Psychopharmacol. 2012;26(11):1408-1416.
7. Baldwin DS, Loft H, Dragheim M. A randomised, double-blind, placebo controlled, duloxetine-referenced, fixed-dose study of three dosages of Lu AA21004 in acute treatment of major depressive disorder (MDD). Eur Neuropsychopharmacol. 2012;22(7):482-491.
8. Alvarez E, Perez V, Dragheim M, et al. A double-blind, randomized, placebo-controlled, active reference study of Lu AA21004 in patients with major depressive disorder. Int J Neuropsychopharmacol. 2012;15(5):589-600.
9. Faris PL, Eckert ED, Kim SW, et al. Evidence for a vagal pathophysiology for bulimia nervosa and the accompanying depressive symptoms. J Affect Disord. 2006;92(1):79-90.
10. Haus U, Varga B, Stratz T, et al. Oral treatment of fibromyalgia with tropisetron given over 28 days: influence on functional and vegetative symptoms, psychometric parameters and pain. Scand J Rheumatol Suppl. 2000;113(Suppl 29):55-58.
11. Hewlett WA, Schmid SP, Salomon RM. Pilot trial of ondansetron in the treatment of 8 patients with obsessive-compulsive disorder. J Clin Psychiatry. 2003;64(9):1025-1030.
12. Johnson BA, Ait-Daoud N, Ma JZ, et al. Ondansetron reduces mood disturbance among biologically predisposed, alcohol-dependent individuals. Alcohol Clin Exp Res. 2003;27(11):1773-1779.
13. Piche T, Vanbiervliet G, Cherikh F, et al. Effect of ondansetron, a 5-HT3 receptor antagonist, on fatigue in chronic hepatitis C: a randomised, double blind, placebo controlled study. Gut. 2005;54(8):1169-1173.
14. Ansseau M, Pitchot W, Moreno AG, et al. Pilot study of flesinoxan, a 5-HT1A agonist, in major depression: effects on sleep REM latency and body temperature. Hum Psychopharmacol. 1993;8(4):279-283.
15. Bielski RJ, Cunningham L, Horrigan JP, et al. Gepirone extended-release in the treatment of adult outpatients with major depressive disorder: a double-blind, randomized, placebo-controlled, parallel-group study. J Clin Psychiatry. 2008;69(4):571-577.
16. Feiger AD, Heiser JF, Shrivastava RK, et al. Gepirone extended-release: new evidence for efficacy in the treatment of major depressive disorder. J Clin Psychiatry. 2003;64(3):243-249.
17. Grof P, Joffe R, Kennedy S, et al. An open study of oral flesinoxan, a 5-HT1A receptor agonist, in treatment-resistant depression. Int Clin Psychopharmacol. 1993;8(3):167-172.
18. Keller MB, Ruwe FJ, Janssens CJ, et al. Relapse prevention with gepirone ER in outpatients with major depression. J Clin Psychopharmacol. 2005;25(1):79-84.
19. Trivedi MH, Fava M, Wisniewski SR, et al; STAR∗D Study Team. Medication augmentation after the failure of SSRIs for depression. N Engl J Med. 2006;354(12):1243-1252.
20. Khin NA, Chen YF, Yang Y, et al. Exploratory analyses of efficacy data from major depressive disorder trials submitted to the US Food and Drug Administration in support of new drug applications. J Clin Psychiatry. 2011;72(4):464-472.
21. Pediatric Product Development. Pediatric Research Equity Act (PREA). US Food and Drug Administration web site. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm049867.htm. Updated June 25, 2014. Accessed October 20, 2014.