Central nervous system biomarkers for antiobesity drug development

Drug Discovery Today

Volumn 18, Issue 23-24, 2013, Pages 1282-1291

  Ziauddeen, Hisham ^a,b   Fletcher, Paul C ^a,b  

^a UNIVERSITY OF CAMBRIDGE   (United Kingdom)

^b CAMBRIDGESHIRE AND PETERBOROUGH NHS FOUNDATION TRUST   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIOBESITY AGENT; BIOLOGICAL MARKER; CANNABINOID 1 RECEPTOR ANTAGONIST; GSK 1521498; GSK 598809; LIRAGLUTIDE; LORCASERIN; RIMONABANT; RM 403; SIBUTRAMINE; TESOFENSINE; UNCLASSIFIED DRUG; VELNEPERIT;

CENTRAL NERVOUS SYSTEM; COGNITION; FEEDING BEHAVIOR; FUNCTIONAL NEUROIMAGING; METABOLISM; MOTIVATION; NEUROPSYCHIATRY; OBESITY; REVIEW; SATIETY; ANIMAL; DRUG DESIGN; DRUG EFFECTS; HUMAN; WEIGHT REDUCTION;

ANIMALS; ANTI-OBESITY AGENTS; BIOLOGICAL MARKERS; CENTRAL NERVOUS SYSTEM; DRUG DESIGN; FEEDING BEHAVIOR; HUMANS; MOTIVATION; OBESITY; WEIGHT LOSS;

EID: 84889098177     PISSN: 13596446     EISSN: 18785832     Source Type: Journal    
DOI: 10.1016/j.drudis.2013.08.015     Document Type: Review

References (69)

1. Public statement on Accomplia: Withdrawal of the marketing authorisation in the European Union. European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) (2009). Available at: http://www.ema.europa.eu/ docs/en-GB/document-library/Public-statement/2009/11/WC500012189.pdf
2. W.P.T.W. James Effect of sibutramine on cardiovascular outcomes in overweight and obese subjects N. Engl. J. Med. 363 2010 905 917
3. Food and Drug Administration (FDA) Center for Drug Evaluation and Research. FDA approves Belviq to treat some overweight or obese adults (2012). Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ ucm309993.htm
4. Food and Drug Administration (FDA) Center for Drug Evaluation and Research. FDA approves weight-management drug Qsymia (2012). Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm312468.htm
5. Withdrawal of the marketing authorisation application for Belviq (lorcaserin). European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) (2013). Available at: http://www.ema.europa.eu/docs/en-GB/ document-library/Medicine-QA/2013/05/WC500143811.pdf
6. Assessment report on Qsiva. European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) (2013). pp. 1-91. Available at: http://www.ema.europa.eu/docs/en-GB/document-library/EPAR-Public-assessment- report/human/002350/WC500144300.pdf
7. Orexigen(R) Therapeutics' Investigational Drug Contrave(R) Receives Positive Recommendation from FDA Advisory Committee for Treatment of Obesity 2010 Orexigen Therapeutics Inc. pp. 1-3. Available at: http://ir.orexigen.com/ phoenix.zhtml?c=207034&p=irol-newsArticle&ID=1505602&highlight =
8. FDA Issues Complete Response to New Drug Application for Contrave(R) for the Management of Obesity 2011 Orexigen Therapeutics Inc. pp. 1-3. Available at: http://ir.orexigen.com/phoenix.zhtml?c=207034&p=irol-newsArticle&ID= 1522207&highlight =
9. Inc OT. Press Release 2009. ir.orexigen.com (2009). pp. 1-4. Available at: http://ir.orexigen.com/phoenix.zhtml?c=207034&p=irol-newsArticle&ID= 1336796&highlight=
10. 3 receptor antagonist GSK598809 on attentional bias to palatable food cues in overweight and obese subjects Int. J. Neuropsychopharm. 15 2012 149 161
11. C.M. Dodds Effect of the dopamine D3 receptor antagonist GSK598809 on brain responses to rewarding food images in overweight and obese binge eaters Appetite 59 2012 27 33
12. L.J. Aronne A clinical trial assessing the safety and efficacy of taranabant, a CB1R inverse agonist, in obese and overweight patients: a high-dose study Int. J. Obes. Relat. Metab. Disord. 34 2010 919 935
13. J. Proietto A clinical trial assessing the safety and efficacy of the CB1R inverse agonist taranabant in obese and overweight patients: low-dose study Int. J. Obes. Relat. Metab. Disord. 34 2010 1243 1254
14. L.J. Aronne Efficacy and safety of CP-945,598, a selective cannabinoid CB1 receptor antagonist, on weight loss and maintenance Obesity 19 2011 1404 1414
15. Takeda Pharmaceutical Company Limited. Amylin and Takeda Discontinue Development of Pramlintide/Metreleptin Combination Treatment for Obesity Following Commercial Reassessment of the Program. Available at: http://www.takeda.com/news/2011/20110805-3889.html
16. A. Astrup Effect of tesofensine on bodyweight loss, body composition, and quality of life in obese patients: a randomised, double-blind, placebo-controlled trial Lancet 372 2008 1906 1913
17. T.L. Editors Expression of concern-effect of tesofensine on bodyweight loss, body composition, and quality of life in obese patients: a randomised, double-blind, placebo-controlled trial Lancet 381 2013 1167
18. T. Vilsboll Effects of glucagon-like peptide-1 receptor agonists on weight loss: systematic review and meta-analyses of randomised controlled trials BMJ 344 2012 d7771
19. Rhythm Initiates Phase 2 Clinical Trial of RM-493 for Obesity (2013). Available at: http://www.rhythmtx.com/NEWS/releases/010413.html
20. Food and Drug Administration (FDA) Center for Drug Evaluation and Research. Guidance for Industry Developing Products for Weight Management. Available at: http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM071612.pdf
21. Guideline on clinical evaluation of medicinal products used in weight control. European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) (2007). Available at: http://www.ema.europa.eu/ema/pages/includes/ document/open-document.jsp?webContentId=WC500003264
22. Summary Minutes of the Endocrinologic and Metabolic Drugs Advisory Committee Meeting March 28-29, 2012. Food and Drug Administration Center for Drug Evaluation and Research. Available at: http://www.fda.gov/downloads/ AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM303352.pdf
23. J.C.G. Halford Pharmacological management of appetite expression in obesity Nat. Rev. Endocrinol. 6 2010 255 269
24. P. Vandenbroeck Foresight, Tackling Obesities: Future Choices-Building the Obesity System Map 2007 Government Office for Science London
25. H. Ziauddeen Effects of the mu-opioid receptor antagonist GSK1521498 on hedonic and consummatory eating behaviour: a proof of mechanism study in binge-eating obese subjects Mol. Psychiatry 2012 10.1038/mp.2012.154 [Epub ahead of print]
26. Biomarkers Definitions Working Group Biomarkers and surrogate endpoints: preferred definitions and conceptual framework Clin. Pharma. Therap. 69 2001 7
27. W. Killgore Cortical and limbic activation during viewing of high- versus low-calorie foods NeuroImage 19 2003 1381 1394
28. P.C. Fletcher Distinct modulatory effects of satiety and sibutramine on brain responses to food images in humans: a double dissociation across hypothalamus, amygdala, and ventral striatum J. Neurosci. 30 2010 14346 14355
29. Y. Rothemund Differential activation of the dorsal striatum by high-calorie visual food stimuli in obese individuals NeuroImage 37 2007 410 421
30. A. Schienle Binge-eating disorder: reward sensitivity and brain activation to images of food Biol. Psychiatry 65 2009 654 661
31. P.A.M. Smeets Effect of satiety on brain activation during chocolate tasting in men and women Am. J. Clin. Nutr. 83 2006 1297 1305
32. A.P. Goldstone Fasting biases brain reward systems towards high-calorie foods Eur. J. Neurosci. 30 2009 1625 1635
33. M.-A. Cornier Effects of overfeeding on the neuronal response to visual food cues Am. J. Clin. Nutr. 86 2007 965 971
34. M.-A. Cornier The effects of overfeeding on the neuronal response to visual food cues in thin and reduced-obese individuals PLoS ONE 4 2009 e6310
35. L.K. Heisler Serotonin reciprocally regulates melanocortin neurons to modulate food intake Neuron 51 2006 239 249
36. K.M.K. Oltmanns Sibutramine promotes amygdala activity under fasting conditions in obese women Psychopharmacology 221 2012 693 700
37. V.C. Cambridge Neural and behavioral effects of a novel mu opioid receptor antagonist in binge-eating obese people Biol. Psychiatry 73 2013 887 894
38. K.S. Smith Ventral pallidum roles in reward and motivation Behav. Brain Res. 196 2009 155 167
39. C.A. Heidbreder The role of central dopamine D3 receptors in drug addiction: a review of pharmacological evidence Brain Res. Rev. 49 2005 77 105
40. J. Horder Effects of 7 days of treatment with the cannabinoid type 1 receptor antagonist, rimonabant, on emotional processing J. Psychopharmacol. 26 2012 125 132
41. P.J. McLaughlin Reports of the death of CB1 antagonists have been greatly exaggerated Behav. Pharmacol. 23 2012 537 550
42. F.J. Meye Neutral antagonism at the cannabinoid 1 receptor: a safer treatment for obesity Mol. Psychiatry 2012 10.1038/mp.2012.145
43. M. Alonso Anti-obesity efficacy of LH-21, a cannabinoid CB1 receptor antagonist with poor brain penetration, in diet-induced obese rats Br. J. Pharmacol. 165 2012 2274 2291
44. G. Kunos, and J. Tam The case for peripheral CB 1receptor blockade in the treatment of visceral obesity and its cardiometabolic complications Br. J. Pharmacol. 163 2011 1423 1431
45. D.F. Wong Quantification of cerebral cannabinoid receptors subtype 1 (CB1) in healthy subjects and schizophrenia by the novel PET radioligand [11C]OMAR NeuroImage 52 2010 1505 1513
46. I.S. Farooqi Leptin regulates striatal regions and human eating behavior Science 317 2007 1355
47. S. Malik Ghrelin modulates brain activity in areas that control appetitive behavior Cell Metab. 7 2008 400 409
48. A. De Silva The gut hormones PYY3-36 and GLP-17-36 amide reduce food intake and modulate brain activity in appetite centers in humans Cell Metab. 14 2011 700 706
49. H.H. Ziauddeen Obesity and the brain: how convincing is the addiction model? Nat. Rev. Neurosci. 13 2012 279 286
50. C. Brignell Attentional and approach biases for pictorial food cues. Influence of external eating Appetite 52 2009 8
51. S.R. Chamberlain Effects of mu opioid receptor antagonism on cognition in obese binge-eating individuals Psychopharmacology 224 2012 501 509
52. A. Drewnowski Naloxone, an opiate blocker, reduces the consumption of sweet high-fat foods in obese and lean female binge eaters Am. J. Clin. Nutr. 61 1995 1206 1212
53. J. Halford The effects of sibutramine on the microstructure of eating behaviour and energy expenditure in obese women J. Psychopharmacol. 24 2010 99 109
54. B. Barkeling Short-term effects of sibutramine (ReductilTM) on appetite and eating behaviour and the long-term therapeutic outcome Int. J. Obes. Relat. Metab. Disord. 27 2003 693 700
55. J.M. Brunstrom, and N.G. Shakeshaft Measuring affective (liking) and non-affective (expected satiety) determinants of portion size and food reward Appetite 52 2009 108 114
56. G. Finlayson Is it possible to dissociate 'liking' and 'wanting' for foods in humans?. A novel experimental procedure Physiol. Behav. 90 2007 36 42
57. S.E. Murphy Effect of a single dose of citalopram on amygdala response to emotional faces Br. J. Psychiatry 194 2009 535 540
58. R. Norbury Short-term antidepressant treatment modulates amygdala response to happy faces Psychopharmacology 206 2009 197 204
59. C.J. Harmer Efficacy markers in depression J. Psychopharmacol. 25 2011 1148 1158
60. C.J. Harmer Effect of acute antidepressant administration on negative affective bias in depressed patients Am. J. Psychiatry 166 2009 1178 1184
61. J. Horder Acute administration of the cannabinoid CB1 antagonist rimonabant impairs positive affective memory in healthy volunteers Psychopharmacology 205 2009 85 91
62. J. Shah Effects of food on the single-dose pharmacokinetics/ pharmacodynamics of tizanidine capsules and tablets in healthy volunteers Clin. Ther. 28 2006 1308 1317
63. P.J. Nathan Multiple-dose safety, pharmacokinetics, and pharmacodynamics of the mu-opioid receptor inverse agonist GSK1521498 J. Clin. Pharmacol. 52 2012 1456 1467
64. P.J. Nathan, and E.T. Bullmore From taste hedonics to motivational drive: central μ-opioid receptors and binge-eating behaviour Int. J. Neuropsychopharm. 12 2009 995
65. I. Elman Food intake and reward mechanisms in patients with schizophrenia: implications for metabolic disturbances and treatment with second-generation antipsychotic agents Neuropsychopharmacology 31 2006 2091 2120
66. D.F.D. Ransohoff Rules of evidence for cancer molecular-marker discovery and validation Nat. Rev. Cancer 4 2004 309 314
67. H. Hampel Development of biomarkers to chart all Alzheimer's disease stages: the royal road to cutting the therapeutic Gordian Knot Alzheimer's Dementia 8 2012 312 336
68. J. Horder Reduced neural response to reward following 7 days treatment with the cannabinoid CB1 antagonist rimonabant in healthy volunteers Int. J. Neuropsychopharmacol. 13 2010 1103 1113
69. K.M. Oltmanns Sibutramine promotes amygdala activity under fasting conditions in obese women Psychopharmacology 221 2011 693 700