MedKoo product information:

 Armodafinil    

Description of  Armodafinil:  Armodafinil is the R-enantiomer of the racemic synthetic agent modafinil with central nervous system (CNS) stimulant and wakefulness-promoting activities. Although the exact mechanism of action has yet to be fully elucidated, armodafinil appears to inhibit the reuptake of dopamine by binding to the dopamine-reuptake pump, which leads to an increase in extracellular dopamine levels in some brain regions. This agent does not bind to or inhibit several receptors and enzymes that may be involved in sleep/wake regulation and is not a direct- or indirect-acting dopamine receptor agonist. Armodafinil has a longer half-life than modafinil. Armodafinil (Nuvigil) is a stimulant-like drug produced by the pharmaceutical company Cephalon Inc., which was approved by the FDA on June 15, 2007. Check for active clinical trials or closed clinical trials using this agent. (NCI Thesaurus).

Current developer: Cephalon Inc

Armodafinil is an enantiopure drug consisting of just the active (−)-(R)-enantiomer of the racemic drug modafinil (Provigil).  Armodafinil is approved by the FDA for the treatment of narcolepsy and shift work sleep disorder, and as an adjunctive treatment for obstructive sleep apnea. Cephalon plans to conduct clinical trials evaluating the use of Nuvigil as a treatment for serious medical conditions such as bipolar depression and fatigue in conditions such as Parkinson's disease and cancer. In June, 2010, it was revealed that a phase II study of armodafinil as an adjunctive therapy in adults with schizophrenia had failed to meet the primary endpoints, and the clinical program was subsequently ceased. The drug was being considered for the first FDA-approved medicinally-specific drug for combating jet-lag. but on March 30, 2010, the FDA declined to approve use of Nuvigil to treat jet lag. (source: http://en.wikipedia.org/wiki/Armodafinil).

1: Kim D. Practical use and risk of modafinil, a novel waking drug. Environ Health Toxicol. 2012;27:e2012007. Epub 2012 Feb 22. PubMed PMID: 22375280; PubMed Central PMCID: PMC3286657.

2: Gehring K, Roukema JA, Sitskoorn MM. Review of recent studies on interventions for cognitive deficits in patients with cancer. Expert Rev Anticancer Ther. 2012 Feb;12(2):255-69. PubMed PMID: 22316373.

3: Tejedor MA, Rubiales AS, Martínez M, Cortés CC. [Asthenia in advanced cancer and the use of psychostimulants]. An Sist Sanit Navar. 2011 Sep-Dec;34(3):471-9. Spanish. PubMed PMID: 22233850.

4: Sugden C, Housden CR, Aggarwal R, Sahakian BJ, Darzi A. Effect of pharmacological enhancement on the cognitive and clinical psychomotor performance of sleep-deprived doctors: a randomized controlled trial. Ann Surg. 2012 Feb;255(2):222-7. PubMed PMID: 21997802.

5: Pruitt AA. Medical management of patients with brain tumors. Curr Treat Options Neurol. 2011 Aug;13(4):413-26. PubMed PMID: 21557041.

6: Campos MP, Hassan BJ, Riechelmann R, Del Giglio A. Cancer-related fatigue: a review. Rev Assoc Med Bras. 2011 Apr;57(2):211-9. Review. English, Portuguese. PubMed PMID: 21537710.

7: Portela MA, Rubiales AS, Centeno C. The use of psychostimulants in cancer patients. Curr Opin Support Palliat Care. 2011 Jun;5(2):164-8. Review. PubMed PMID: 21532350.

8: Crowley RK, Woods C, Fleming M, Rogers B, Behan LA, O'Sullivan EP, Kane T, Agha A, Smith D, Costello RW, Thompson CJ. Somnolence in adult craniopharyngioma patients is a common, heterogeneous condition that is potentially treatable. Clin Endocrinol (Oxf). 2011 Jun;74(6):750-5. doi: 10.1111/j.1365-2265.2011.03993.x. PubMed PMID: 21521265.

9: Adams C, McKeon A, Silber MH, Kumar R. Narcolepsy, REM sleep behavior disorder, and supranuclear gaze palsy associated with Ma1 and Ma2 antibodies and tonsillar carcinoma. Arch Neurol. 2011 Apr;68(4):521-4. Erratum in: Arch Neurol. 2011 Sep;68(9):1211. PubMed PMID: 21482933.

10: De Waele S, Van Belle S. Cancer-related fatigue. Acta Clin Belg. 2010 Nov-Dec;65(6):378-85. Review. PubMed PMID: 21268950.

11: Joly F, Rigal O, Noal S, Giffard B. Cognitive dysfunction and cancer: which consequences in terms of disease management? Psychooncology. 2011 Dec;20(12):1251-8. doi: 10.1002/pon.1903. Epub 2011 Jan 21. Review. PubMed PMID: 21254307.

12: Peuckmann V, Elsner F, Krumm N, Trottenberg P, Radbruch L. Pharmacological treatments for fatigue associated with palliative care. Cochrane Database Syst Rev. 2010 Nov 10;(11):CD006788. Review. PubMed PMID: 21069692.

13: Wirz S, Nadstawek J, Kühn KU, Vater S, Junker U, Wartenberg HC. [Modafinil for the treatment of cancer-related fatigue : an intervention study]. Schmerz. 2010 Dec;24(6):587-95. German. PubMed PMID: 21046171.

14: Breitbart W, Alici Y. Psychostimulants for cancer-related fatigue. J Natl Compr Canc Netw. 2010 Aug;8(8):933-42. Review. PubMed PMID: 20870637.

15: Dees EC, Infante JR, Cohen RB, O'Neil BH, Jones S, von Mehren M, Danaee H, Lee Y, Ecsedy J, Manfredi M, Galvin K, Stringer B, Liu H, Eton O, Fingert H, Burris H. Phase 1 study of MLN8054, a selective inhibitor of Aurora A kinase in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2011 Apr;67(4):945-54. Epub 2010 Jul 7. PubMed PMID: 20607239; PubMed Central PMCID: PMC3026871.

16: Jean-Pierre P, Morrow GR, Roscoe JA, Heckler C, Mohile S, Janelsins M, Peppone L, Hemstad A, Esparaz BT, Hopkins JO. A phase 3 randomized, placebo-controlled, double-blind, clinical trial of the effect of modafinil on cancer-related fatigue among 631 patients receiving chemotherapy: a University of Rochester Cancer Center Community Clinical Oncology Program Research base study. Cancer. 2010 Jul 15;116(14):3513-20. PubMed PMID: 20564068; PubMed Central PMCID: PMC2941794.

17: Escalante CP, Manzullo EF. Cancer-related fatigue: the approach and treatment. J Gen Intern Med. 2009 Nov;24 Suppl 2:S412-6. Review. PubMed PMID: 19838841; PubMed Central PMCID: PMC2763160.

18: Lundorff LE, Jønsson BH, Sjøgren P. Modafinil for attentional and psychomotor dysfunction in advanced cancer: a double-blind, randomised, cross-over trial. Palliat Med. 2009 Dec;23(8):731-8. Epub 2009 Jul 31. PubMed PMID: 19648224.

19: Blackhall L, Petroni G, Shu J, Baum L, Farace E. A pilot study evaluating the safety and efficacy of modafinal for cancer-related fatigue. J Palliat Med. 2009 May;12(5):433-9. PubMed PMID: 19416039.

20: Cooper MR, Bird HM, Steinberg M. Efficacy and safety of modafinil in the treatment of cancer-related fatigue. Ann Pharmacother. 2009 Apr;43(4):721-5. Epub 2009 Mar 24. Review. PubMed PMID: 19318599.

21: Kohli S, Fisher SG, Tra Y, Adams MJ, Mapstone ME, Wesnes KA, Roscoe JA, Morrow GR. The effect of modafinil on cognitive function in breast cancer survivors. Cancer. 2009 Jun 15;115(12):2605-16. PubMed PMID: 19309747; PubMed Central PMCID: PMC2796482.

22: Spathis A, Dhillan R, Booden D, Forbes K, Vrotsou K, Fife K. Modafinil for the treatment of fatigue in lung cancer: a pilot study. Palliat Med. 2009 Jun;23(4):325-31. Epub 2009 Mar 6. PubMed PMID: 19270033.

23: Narayanan V, Koshy C. Fatigue in cancer: a review of literature. Indian J Palliat Care. 2009 Jan;15(1):19-25. PubMed PMID: 20606851; PubMed Central PMCID: PMC2886215.

24: Rosenthal TC, Majeroni BA, Pretorius R, Malik K. Fatigue: an overview. Am Fam Physician. 2008 Nov 15;78(10):1173-9. Review. PubMed PMID: 19035066.

25: Biegler KA, Chaoul MA, Cohen L. Cancer, cognitive impairment, and meditation. Acta Oncol. 2009;48(1):18-26. Review. PubMed PMID: 19031161.

26: Rao AV, Cohen HJ. Fatigue in older cancer patients: etiology, assessment, and treatment. Semin Oncol. 2008 Dec;35(6):633-42. Review. PubMed PMID: 19027467.

27: Breitbart W, Alici Y. Pharmacologic treatment options for cancer-related fatigue: current state of clinical research. Clin J Oncol Nurs. 2008 Oct;12(5 Suppl):27-36. Review. PubMed PMID: 18842522.

28: McNeil C. No rest for fatigue researchers. J Natl Cancer Inst. 2008 Aug 20;100(16):1129-31. Epub 2008 Aug 11. PubMed PMID: 18695127.

29: Harris JD. Fatigue in chronically ill patients. Curr Opin Support Palliat Care. 2008 Sep;2(3):180-6. Review. PubMed PMID: 18685418.

30: Daud ML. Drug management of terminal symptoms in advanced cancer patients. Curr Opin Support Palliat Care. 2007 Oct;1(3):202-6. Review. PubMed PMID: 18685364.

31: Hampton T. Cancer investigators make strides in improving patients' quality of life. JAMA. 2008 Jul 23;300(4):383. PubMed PMID: 18647974.

32: Schnoll RA, Wileyto EP, Pinto A, Leone F, Gariti P, Siegel S, Perkins KA, Dackis C, Heitjan DF, Berrettini W, Lerman C. A placebo-controlled trial of modafinil for nicotine dependence. Drug Alcohol Depend. 2008 Nov 1;98(1-2):86-93. Epub 2008 Jun 9. PubMed PMID: 18541389; PubMed Central PMCID: PMC2610628.

33: Breitbart W, Alici-Evcimen Y. Update on psychotropic medications for cancer-related fatigue. J Natl Compr Canc Netw. 2007 Nov;5(10):1081-91. Review. PubMed PMID: 18053430.

34: Carroll JK, Kohli S, Mustian KM, Roscoe JA, Morrow GR. Pharmacologic treatment of cancer-related fatigue. Oncologist. 2007;12 Suppl 1:43-51. Review. PubMed PMID: 17573455.

35: Prommer E. Modafinil: is it ready for prime time? J Opioid Manag. 2006 May-Jun;2(3):130-6. Review. PubMed PMID: 17319446.

36: Spathis A. Medicinal studies in palliative care: impact of the EU clinical trials directive. Palliat Med. 2007 Jan;21(1):60-1. PubMed PMID: 17169963.

37: Reineke-Bracke H, Radbruch L, Elsner F. Treatment of fatigue: modafinil, methylphenidate, and goals of care. J Palliat Med. 2006 Oct;9(5):1210-4. PubMed PMID: 17040162.

38: Wen PY, Schiff D, Kesari S, Drappatz J, Gigas DC, Doherty L. Medical management of patients with brain tumors. J Neurooncol. 2006 Dec;80(3):313-32. Epub 2006 Jun 29. Review. PubMed PMID: 16807780.

39: Rivera VM. Modafinil for the treatment of diminished responsiveness in a patient recovering from brain surgery. Brain Inj. 2005 Aug 20;19(9):725-7. PubMed PMID: 16195186.

40: Schwartz JR, Feldman NT, Bogan RK. Dose effects of modafinil in sustaining wakefulness in narcolepsy patients with residual evening sleepiness. J Neuropsychiatry Clin Neurosci. 2005 Summer;17(3):405-12. Erratum in: J Neuropsychiatry Clin Neurosci. 2005 Fall;17(4):561. PubMed PMID: 16179665.

41: Morrow GR, Shelke AR, Roscoe JA, Hickok JT, Mustian K. Management of cancer-related fatigue. Cancer Invest. 2005;23(3):229-39. Review. PubMed PMID: 15945509.

42: Raison CL, Demetrashvili M, Capuron L, Miller AH. Neuropsychiatric adverse effects of interferon-alpha: recognition and management. CNS Drugs. 2005;19(2):105-23. Review. PubMed PMID: 15697325; PubMed Central PMCID: PMC1255968.

43: Spathis A, Morrish E, Booth S, Smith IE, Shneerson JM. Selective circadian rhythm disturbance in cerebral lymphoma. Sleep Med. 2003 Nov;4(6):583-6. PubMed PMID: 14607354.

44: Marcus CL, Trescher WH, Halbower AC, Lutz J. Secondary narcolepsy in children with brain tumors. Sleep. 2002 Jun 15;25(4):435-9. PubMed PMID: 12071545.