Advertisement

The development of Sativex® — a natural cannabis-based medicine

  • Geoffrey W. Guy
  • Colin G. Stott
Part of the Milestones in Drug Therapy MDT book series (MDT)

Keywords

Neuropathic Pain Central Neuropathic Pain Clinical Study Report Alternative Investment Market Cannabis Extract 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. 1.
    Aldrich MR (1997) History of therapeutic cannabis. In: ML Mathre (ed.): Cannabis in Medical Practice: A Legal, Historical and Pharmacological Overview of the Therapeutic Use of Marijuana. McFarland & Co., Inc. Jefferson NC, 28640; USA, 35–55Google Scholar
  2. 2.
    Russo EB (2001) Hemp for headache: An in-depth historical and scientific review of cannabis in migraine treatment. J Cannabis Ther 1(2): 21–92CrossRefGoogle Scholar
  3. 3.
    Russo EB (2002) Cannabis treatments in obstetrics and gynaecology: A historical review. J Cannabis Ther 2(3–4): 5–35CrossRefGoogle Scholar
  4. 4.
    Grinspoon L, Bakalar JB (1993) History of the use of cannabis. In: Marihuana, the Forbidden Medicine. Yale University Press, New Haven, CTGoogle Scholar
  5. 5.
    The House of Lords Science and Technology Committee — Ninth Report 1998. Cannabis: the Scientific Evidence. HMG The Stationery Office, London, UKGoogle Scholar
  6. 6.
    Gaoni Y, Mechoulam R (1964) Isolation, structure, and partial synthesis of an active constituent of hashish. JAm Chem Soc 86: 1646–1647CrossRefGoogle Scholar
  7. 7.
    Chan PC, Boorman GA, Bridge DA, Bucher JR, Elwell MR, Goehl TJ, Haseman JK, Rao GN, Roycroft JH, Sills RC et al. (1996) 1-Trans-Delta9-Tetrahydrocannabinol (Cas No. 1972-08-3): Studies of Toxicology and Carcinogenesis In F344/N Rats And B6c3fl Mice (Gavage Studies). U.S. Department of Health And Human Services, Public Health Service, National Institutes of Health (NIH) Technical Report Series No. NTP TR 446; NIH Publication No. 97-3362 (1996), Bethesda, MDGoogle Scholar
  8. 8.
    Joy JE, Watson SJ Jr, Benson JA Jr (eds) (1999) Marijuana and Medicine — Assessing the Science Base. Division of Neuroscience and Behavioral Health, Institute of Medicine National Academy of Sciences, National Academy Press, Washington, D.CGoogle Scholar
  9. 9.
    Beaver WT, Buring J, Goldstein A, Johnson K, Jones R, Kris MG, Mooney K, Palmberg P, Phair J (1997) NIH Report on the medical uses of marijuana, 08 August 1997. From the Workshop on the Medical Utility of Marijuana (19 and 20 Feb 1997) National Institutes of Health (NIH), Bethesda, MDGoogle Scholar
  10. 10.
    AMA Medical Marijuana (1997) Council on Scientific Affairs Report 10. Medical marijuana. American Medical Association, Interim Meeting, Dallas, TX, December 1997. http://www.ama-assn.org/ama/pub/article/2036-4299.htmlGoogle Scholar
  11. 11.
    (1997) Therapeutic Uses of Cannabis. BMA/Harwood Academic Publishers, AmsterdamGoogle Scholar
  12. 12.
    Ashton CH (2001) Pharmacology and effects of cannabis: a brief review. Br J Psychiat 178:101–106CrossRefGoogle Scholar
  13. 13.
    Robson PJ (2001) Therapeutic aspects of cannabis and cannabinoids. Br J Psychiat 178: 107–115CrossRefGoogle Scholar
  14. 14.
    Johns A (2001) Psychiatric aspects of cannabis use. Br J Psychiat 178: 116–122CrossRefGoogle Scholar
  15. 15.
    Cannabis: The Scientific and Medical Evidence (11 November 1998) HM Government: House of Lords Science and Technology Select Committee Science and Technology Ninth Report (Session 1997–98). HL 151Google Scholar
  16. 16.
    Therapeutic Uses of Cannabis (21 March 2001) HM Government: House of Lords Science and Technology Select Committee Science and Technology Second Report (Session 2000–01). HL 50Google Scholar
  17. 17.
    Elphick M, Ergetova MR (2001) The neurobiology and evolution of cannabinoid signalling. Phil Trans R Soc Lond B 356(1407): 381–408CrossRefGoogle Scholar
  18. 18.
    Howlett AC (1984) Inhibition of neuroblastoma adenylate cyclase by cannabinoid and nantradol compounds. Life Sci 35(17): 1803–1810CrossRefPubMedGoogle Scholar
  19. 19.
    Howlett AC, Fleming MR (1984) Cannabinoid inhibition of adenylate cyclase. Pharmacology of the response in neuroblastoma cell membranes. Mol Pharmacol 26(3): 532–538PubMedGoogle Scholar
  20. 20.
    Devane WA, Dysarz FA 3rd, Johnson MR, Melvin LS, Howlett AC (1988) Determination and characterization of a cannabinoid receptor in rat brain. Mol Pharmacol 34(5): 605–613PubMedGoogle Scholar
  21. 21.
    Matsuda LA, Lolait SJ, Brownstein MJ, Young AC, Bonner TI (1990) Structure of a cannabinoid receptor and functional expression of the cloned cDNA. Nature 346(6284): 561–564CrossRefPubMedGoogle Scholar
  22. 22.
    Munro S, Thomas KL, Abu-Shaar M (1993) Molecular characterization of a peripheral receptor for cannabinoids. Nature 365(6441): 61–65CrossRefPubMedGoogle Scholar
  23. 23.
    GW Pharmaceuticals plc website www.gwpharm.com. Research and Development/Cannabis-based Medicines/Cannabinoids. http://www.gwpharm.com/research_cannabinoids.aspGoogle Scholar
  24. 24.
    Pertwee RG (1997) Pharmacology of CB1 and CB2 Receptors. Pharmacol Ther 74(2): 129–180CrossRefPubMedGoogle Scholar
  25. 25.
    Devane WA, Hanuš L, Breuer A, Pertwee RG, Stevenson LA, Griffin G, Gibson D, Mandelbaum A, Etinger A, Mechoulam R (1992) Isolation and structure of a brain constituent that binds to the cannabinoid receptor. Science 258(5090): 1946–1949PubMedGoogle Scholar
  26. 26.
    Freund TF, Katona I, Piomelli D (2003) Role of endogenous cannabinoids in synaptic signalling. Physiol Rev 83(3): 1017–1066PubMedGoogle Scholar
  27. 27.
    Hanuš L, Abu-Lafi S, Fride E, Breuer A, Vogel Z, Shalev DE, Kustanovich I, Mechoulam R (2001) 2-Arachidonyl glyceryl ether, an endogenous agonist of the cannabinoid CB1 receptor. Proc Natl Acad Sci USA 98(7): 3662–3665CrossRefPubMedGoogle Scholar
  28. 28.
    Porter AC, Sauer JM, Knierman MD, Becker GW, Berna MJ, Bao J, Nomikos GG, Carter P, Bymaster FP, Leese AB, Felder CC (2002) Characterization of a novel endocannabinoid, virodhamine, with antagonist activity at the CB1 receptor. J Pharmacol Exp Ther 301(3): 1020–1024CrossRefPubMedGoogle Scholar
  29. 29.
    Huang SM, Bisogno T, Trevisani M, Al-Hayani A, De Petrocellis L, Fezza F, Tognetto M, Petros TJ, Krey JF, Chu CJ, Miller JD et al. (2002) An endogenous capsaicin-like substance with high potency at recombinant and native vanilloid VR1 receptors. Proc Natl Acad Sci USA 99(12):8400–8405CrossRefPubMedGoogle Scholar
  30. 30.
    Millman G, Maor Y, Horowitz M, Gallily R, Hanug L, Mechoulam R (2004) Arachidonoyl-serine, an endocannabinoid-like bioactive constituent of rat brain. 2004 Symposium on the Cannabinoids, ICRS, Burlington, Vermont, ICRS, 133Google Scholar
  31. 31.
    McPartland J, Russo EB (2001) Cannabis and cannabis extracts: greater than the sum of their parts? J Cannabis Ther 1(3–4): 103–132CrossRefGoogle Scholar
  32. 32.
    Russo EB, McPartland J (2003) Cannabis is more than simply delta-9-tetrahydrocannabinol. Psychopharmacology 165: 431–432PubMedGoogle Scholar
  33. 33.
    Mechoulam R, Ben-Zvi Z, Shani A, Zemler H, Levy S (2001) Cannabinoids and Cannabis activity. In: WDM Paton, J Crown (eds): Cannabis and its derivatives. Oxford University Press, London, 1–13Google Scholar
  34. 34.
    Carlini EA, Karniol IG, Renault PF, Schuster CR (1974) Effects of marihuana in laboratory animals and man. Brit J Pharmacol 50: 299–309Google Scholar
  35. 35.
    Fairbairn JW, Pickens JT (1981) Activity of cannabis in relation to its delta-l-trans-tetrahydro-cannabinol con tent. Brit J Pharmacol 72: 401–409Google Scholar
  36. 36.
    Grinspoon L, Bakalar JB (1997) Marihuana, the forbidden medicine, revised edition. Yale University Press, New Haven, CTGoogle Scholar
  37. 37.
    Browne RG, Weissman A (1981) Discriminative stimulus properties of delta-9-tetrahydrocannabinol: mechanistic studies. J Clin Pharmacol 21(8–9 Suppl): 227S–234SPubMedGoogle Scholar
  38. 38.
    GW Pharmaceuticals plc. Clinical Study Report GWPKOOO8 (data on file)Google Scholar
  39. 39.
    McPartland J (2003) Neurobiological effects of cannabinoids. Lecture: American Academy of Pain Management (AAPM), 4 Sept 2003Google Scholar
  40. 40.
    Walton RP (1938) ((Title?)) In: Marihuana, America’s new drug problem. J.B. Lippincott Co., Philadelphia, USA, 49Google Scholar
  41. 41.
    Pertwee RG (2004) The pharmacology and therapeutic potential of cannabidiol In: V Di Marzo (eds): Cannabinoids. Kluwer Academic/Plenum PublishersGoogle Scholar
  42. 42.
    Whittle BA, Guy GW, Robson P (2001) Prospects for new cannabis-based prescription medicines. J Cannabis Ther 1(3–4): 183–205CrossRefGoogle Scholar
  43. 43.
    Whittle BA, Guy GW (2004) Development of cannabis-based medicines: risk, benefit and serendipity. In: GW Guy, PJ Robson, BA Whittle (eds): The Medicinal Uses of Cannabis and Cannabinoids. Pharmaceutical Press, LondonGoogle Scholar
  44. 44.
    European Medicines Evaluation Agency (EMEA). http://www.emea.eu.int/index/indexhl.htmGoogle Scholar
  45. 45.
    Food and Drug Administration (FDA) (2004) Guidance for Industry: Botanical Drug Products (June 2004) Drug Information Branch (HFD-210), Center for Drug Evaluation and Research (CDER), FDA, Rockville, MDGoogle Scholar
  46. 46.
    Potter DJ (2004) Growth and morphology of medicinal cannabis. In: GW Guy, PJ Robson, BA Whittle (eds): The Medicinal Uses of Cannabis and Cannabinoids. Pharmaceutical Press, LondonGoogle Scholar
  47. 47.
    Guy GW, Flint ME (2003) A single centre, placebo-controlled, four period, crossover, tolerability study assessing, pharmacodynamic effects, pharmacokinetic characteristics and cognitive profiles of a single dose of three formulations of cannabis based medicine extracts (CBMEs) (GWPD9901), plus a two period tolerability study comparing pharmacodynamic effects and pharmacokinetic characteristics of a single dose of a cannabis based medicine extract given via two administration routes (GWPD9901 EXT). J Cannabis Ther 3(3): 35–77CrossRefGoogle Scholar
  48. 48.
    Guy GW, Robson PJ (2003) A Phase I, Open Label, Four-Way Crossover Study to Compare the Pharmacokinetic Profiles of a Single Dose of 20 mg of a Cannabis Based Medicine Extract (CBME) Administered on 3 Different Areas of the Buccal Mucosa and to Investigate the Pharmacokinetics of CBME per Oral in Healthy Male and Female Volunteers (GWPK0112). J Cannabis Ther 3: 79–120CrossRefGoogle Scholar
  49. 49.
    Guy GW, Robson PJ (2003) A Phase I, Double Blind, Three-Way Crossover Study to Assess the Pharmacokinetic Profile of Cannabis Based Medicine Extract (CBME) Administered Sublingually in Variant Cannabinoid Ratios in Normal Healthy Male Volunteers (GWPK0215). J Cannabis Ther 3: 121–152CrossRefGoogle Scholar
  50. 50.
    Notcutt W, Price M, Miller R, Newport S, Phillips C, Simmons S, Sansom C (2004) Initial experiences with medicinal extracts of cannabis for chronic pain: results from 34 ‘N of 1’ studies. Anaesthesia 59(5): 440–452CrossRefPubMedGoogle Scholar
  51. 51.
    Wade DT, Robson PJ, House H, Makela P, Aram J (2003) A preliminary controlled study to determine whether whole-plant cannabis extracts can improve intractable neurogenic symptoms. Clin Rehabil 17: 21–29CrossRefPubMedGoogle Scholar
  52. 52.
    Brady CM, DasGupta R, Dalton C, Wiseman OJ, Berkley KJ and Fowler CJ (2004) An open-label pilot study of cannabis-based extracts for bladder dysfunction in advanced multiple sclerosis. Mult Scler 10: 425–433CrossRefPubMedGoogle Scholar
  53. 53.
    GW Pharmaceuticals — Study GWN19904 — Clinical Study Report (data on file)Google Scholar
  54. 54.
    GW Pharmaceuticals — Study GWCRI016 — Clinical Study Report (data on file)Google Scholar
  55. 55.
    Rog DJ, Young CA (2003) Randomised controlled trial of Cannabis Based Medicinal Extracts in central neuropathic pain due to multiple sclerosis. Abstracts of the 19th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS, September 17–20, 2003, Milan, Italy). Mult Sclerosis 9(Suppl. 1): S1–S162CrossRefGoogle Scholar
  56. 56.
    Berman JS, Symonds C, Birch R (2004) Efficacy of two cannabis based medicinal extracts for relief of central neuropathic pain from brachial plexus avulsion: results of a randomized controlled trial. Pain 112: 299–306CrossRefPubMedGoogle Scholar
  57. 57.
    Sharief MK (2004) Sativex® in the treatment of patients with chronic refractory pain due to MS or other defects of neurological function. Spring Scientific Meeting (2004) Association Of British Neurologists (14–16 April 2004, Church House, Westminster, London). Abstract.Google Scholar
  58. 58.
    Wade DT, Makela P, Robson PJ, House H, Bateman C (2004) Do cannabis-based medicinal extracts have general or specific effects on symptoms in multiple sclerosis? A double-blind, randomized, placebo controlled study on 160 patients. Mult Scler 10: 434–441CrossRefPubMedGoogle Scholar
  59. 59.
    GW Pharmaceuticals plc — Study GWMS0106 — Clinical Study Report (data on file)Google Scholar
  60. 60.
    GW Pharmaceuticals plc — Study GWNP0101 — Clinical Study Report (data on file)Google Scholar
  61. 61.
    Svendsen KB, Jensen TS, Bach FW (2004) Does the cannabinoid dronabinol reduce central pain in multiple sclerosis? Randomised double blind placebo controlled crossover trial. BMJ 329: 253–260CrossRefPubMedGoogle Scholar
  62. 62.
    Nicholson AN, Turner C, Stone BM, Robson PJ (2004) Effect of D-9-Tetrahydrocannabinol and Cannabidiol on Nocturnal Sleep and Early-Morning Behavior in Young Adults. J Clin Psychopharmacol 24(3): 305–313PubMedGoogle Scholar
  63. 63.
    Wade DT, Makela P, Robson PJ, House H, Bateman C (2005) Long-term use of a cannabis-based medicine in the treatment of spasticity and other symptoms in multiple sclerosis. Mult Scler; submittedGoogle Scholar
  64. 64.
    GW Pharmaceuticals plc — Study GWEXT0102 — data on fileGoogle Scholar

Copyright information

© Birkhäuser Verlag/Switzerland 2005

Authors and Affiliations

  • Geoffrey W. Guy
    • 1
  • Colin G. Stott
    • 1
  1. 1.GW Pharmaceuticals plcSalisbury, WiltshireUK

Personalised recommendations