Cannabinoids for use in the treatment of neuropathic pain
| Title: | Cannabinoids for use in the treatment of neuropathic pain |
|---|---|
| Patent Number: | 9,895,342 |
| Publication Date: | February 20, 2018 |
| Appl. No: | 14/118563 |
| Application Filed: | May 18, 2012 |
| Abstract: | The present invention relates to cannabinoids for use in the treatment of neuropathic pain. Preferably the cannabinoids are one or more phytocannabinoids of: cannabigerol (CBG), cannabichromene (CBC), cannabidivarin (CBDV) or tetrahydrocannabivarin (THCV). More preferably the phytocannabinoids are isolated and/or purified from cannabis plant extracts. |
| Inventors: | Maione, Sabatino (Naples, IT); Rossi, Francesco (Naples, IT); Guy, Geoffrey (Salisbury, GB); Stott, Colin (Salisbury, GB); Kikuchi, Tetsuro (Osaka, JP) |
| Assignees: | GW Pharma Limited (Cambridge, GB) |
| Claim: | 1. A method of treating a patient with neuropathic pain consisting essentially of administering to the patient an effective amount of cannabidivarin (CBDV) wherein the CBDV is of a purity of greater than 99% (w/w), or is produced synthetically and does not include cannabidiol (CBD) and/or tetrahydrocannabinol (THC). |
| Claim: | 2. The method as claimed in claim 1 , wherein the neuropathic pain is peripheral neuropathic pain. |
| Claim: | 3. The method as claimed in claim 2 , wherein the peripheral neuropathic pain is allodynia. |
| Claim: | 4. The method as claimed in claim 1 , wherein the CBDV is present in an effective human daily dose to relieve neuropathic pain. |
| Claim: | 5. The method as claimed in claim 4 , wherein the effective human daily dose of CBDV is between 5 mg and 100 mg. |
| Claim: | 6. The method as claimed in claim 5 , wherein the effective human daily dose of CBDV is between 10 mg and 50 mg. |
| Claim: | 7. The method as claimed in claim 1 , wherein the CBDV is packaged for use for an extended treatment period. |
| Claim: | 8. The method as claimed in claim 7 , wherein the extended treatment period is at least 7 days. |
| Claim: | 9. The method as claimed in claim 1 , wherein the CBDV is administered to the patient in combination with one or more other medicinal substances used in the treatment of neuropathic pain. |
| Patent References Cited: | 5945416 August 1999 Womer 6730330 May 2004 Whittle et al. 6946150 September 2005 Whittle 6949582 September 2005 Wallace 7700368 April 2010 Flockhart et al. 7709536 May 2010 Whittle 7968594 June 2011 Guy et al. 8053476 November 2011 Selve 8211946 July 2012 Whittle 2003/0021752 January 2003 Whittle et al. 2004/0138293 July 2004 Werner et al. 2004/0192760 September 2004 Whittle et al. 2010/0016418 January 2010 Guy et al. 2010/0035978 February 2010 Guy et al. 2012/0245224 September 2012 Guy et al. 2 517 313 February 2007 2 377 633 January 2003 2 381 194 April 2003 2 391 865 February 2004 2 392 093 February 2004 2 394 894 May 2004 2 439 393 December 2007 2 448 535 October 2008 2 450 493 December 2008 WO 02/064109 August 2002 WO 02/069993 September 2002 WO 03/037306 May 2003 WO 2004/016246 February 2004 WO 2005/120478 December 2005 WO 2007/148094 December 2007 |
| Other References: | Examination Report for GB 0612512.4 dated Nov. 12, 2010. cited by applicant Examination Report for GB 1108506.5 completed Sep. 13, 2011. cited by applicant International Search Report and Written Opinion for International Application No. PCT/GB2006/004063, dated Jan. 2, 2007. cited by applicant International Preliminary Report on Patentability for International Application No. PCT/GB2006/004063, dated Dec. 5, 2007. cited by applicant International Search Report and Written Opinion for International Application No. PCT/GB2007/002315 dated Sep. 6, 2007. cited by applicant International Preliminary Report on Patentability for International Application No. PCT/GB2007/002315 dated Jun. 19, 2008. cited by applicant International Search Report and Written Opinion for International Application No. PCT/GB2012/051129 dated Aug. 14, 2012. cited by applicant International Preliminary Report on Patentability for International Application No. PCT/GB2012/051129 dated Nov. 20, 2013. cited by applicant [No Author Listed] “Cannabis-based medicines—high CBD, high THC, medicinal cannabis,” Drugs in R&D 2003; 4(5):306-309. cited by applicant Barnes, Sativex: clinical efficacy and tolerability in the treatment of symptoms of multiple sclerosis and neuropathic pain. Expert Opin Pharmacother. Apr. 2006;7(5):607-15. cited by applicant Blake, et al., Preliminary assessment of the efficacy, tolerability and safety of a cannabis-based medicine (sativex) in the reatment of pain caused by rheumatoid artritis,Rheumatology 2006;45:50-52. cited by applicant Colburn et al., Attenuated cold sensitivity in TRPM8 null mice. Neuron. May 3, 2007;54(3):379-86. cited by applicant Costa et al., Oral anti-inflammatory activity of cannabidiol, a non-psychoactive constituent of cannabis, in acute carrageenan-induced inflammation in the rat paw. Naunyn Schmiedebergs Arch Pharmacol. Mar. 2004;369(3):294-9. Epub Feb. 12, 2004. cited by applicant De Petrocellis et al., Plant-derived cannabinoids modulate the activity of transient receptor potential channels of ankyrin type-1 and melastatin type-8. J Pharmacol Exp Ther. Jun. 2008;325(3):1007-15. doi: 10.1124/jpet.107.134809. Epub Mar. 19, 2008. cited by applicant Grond et al., Assessment and treatment of neuropathic cancer pain following WHO guildelines. Pain 79 (1999), pp. 15-20. cited by applicant Hensen, B., “Cannabinoid therapeutics: high hopes for the future,” Drug Discovery Today Apr. 1, 2005; 10(7):459-462. cited by applicant Izzo et al., Non-psychotropic plant cannabinoids: new therapeutic opportunities from an ancient herb. Trends Pharmacol Sci. Oct. 2009;30(10):515-27. cited by applicant Nurmikko, et al., A multi-centre, double-blind, randomized, placebo-controlled trial of oro-mucosal cannabis-based medicine in the treatment of neuropathic pain characterized by alloydnia. PO6. 119, Neurology, Mar. 2005, 64(6) Suppl. 1, p. A 374. cited by applicant Perez, Combined cannabinoid therapy via an oromucosal spray. Drugs Today (Barc). Aug. 2006;42(8):495-503. cited by applicant Perras, Sativex for the management of multiple sclerosis symptoms. Issues Emerg Health Technol. Sep. 2005;(72):1-4. cited by applicant Polomano et al., A painful peripheral neuropathy in the rat produced by the chemotherapeutic drug, paclitaxel. Pain 94 (2001), pp. 293-304. cited by applicant Puéchal et al., Peripheral neuropathy with necrotizing vasculitis in rheumatoid arthritis. A clinicopathologic and prognostic study of thirty-two patients. Arthritis Rheum. Nov. 1995;38(11):1618-29. cited by applicant Russo et al., A tale of two cannabinoids: the therapeutic rationale for combining tetrahydrocannabinol and cannabidiol. Med Hypotheses. 2006;66(2):234-46. Epub Oct. 4, 2005. cited by applicant Smith, GW-1000. GW Pharmaceuticals, Current Opinion on Investigational Drugs, Jul. 2004, 5(7), pp. 748-754. cited by applicant The United Kingdom Parliament, Select Committee on Science and Technology Ninth Report (1998) at http://www.parliament.the-stationery-office.co.uk/pa/ld199798/ldselect/ldsctech/151/15101.htm. cited by applicant The United Kingdom Parliament, Select Committee on Science and Technology Second Report (Mar. 14, 2001) at http://www.publications.parliament.uk/pa/ld200001/ldselect/ldsctech/50/5001.htm. cited by applicant Third Party Observations for Application No. AU2012260611 mailed Dec. 20, 2014. cited by applicant Third Party Observations for Application No. EP12722495.4 mailed Jan. 28, 2015. cited by applicant Bakhsh et al., Miftaah-al-Khazaain. 1930: 607-8. Urdu. Exhibit 3. cited by applicant Dasa et al., Bhaisajya Ratnavali. Chaukhamba Sanskrit Sansthan, Varanasi. Edn. 14. 2001: 347. Sanskrit. Exhibit 6. cited by applicant Dasa et al., Brhat Nighantu Ratnakara (Saligramanighantubhusanam). vol. IV (Part VII).1997:170. Sanskrit. Exhibit 3. cited by applicant Gupta et al., Bharata Bhaisajya Ratnakara. Jain Publishers, New Delhi, 2nd Edn. Aug. 1999:399. Sanskrit. Exhibit 5. cited by applicant Guy et al., The development of Sativex® —A natural cannabis-based medicine Cannabinoids as Therapeutics. 2005: 231-63. cited by applicant Khan et al., Khazaain-al-Adiva. vol. I. 1911: 886. Urdu. Exhibit 2. cited by applicant Khan et al., Khazaain-al-Adiva. vol. I. 1911: 887. Urdu. Exhibit 5. cited by applicant Khan et al., Khazaain-al-Adiva. vol. I. 1911: 889. Urdu. Exhibit 4. cited by applicant Khan et al., Khazaain-al-Advia. vol. III. 1926: 519. Urdu. Exhibit 1. cited by applicant Elsohly et al., Chemical constituents of marijuana: the complex mixture of natural cannabinoids. Life Sci. Dec. 22, 2005;78(5):539-48. Epub Sep. 30, 2005. cited by applicant De Petrocellis et al., Effects of cannabinoids and cannabinoid-enriched Cannabis extracts on TRP channels and endocannabinoid metabolic enzymes. Br J Pharmacol. Aug. 2011;163(7):1479-94. doi: 10.1111/j.1476-5381.2010.01166.x. cited by applicant Pertwee, The diverse CB1 and CB2 receptor pharmacology of three plant cannabinoids: delta9-tetrahydrocannabinol, cannabidiol and delta9-tetrahydrocannabivarin. Br J Pharmacol. Jan. 2008;153(2):199-215. Epub Sep. 10, 2007. cited by applicant Wade et al., A preliminary controlled study to determine whether whole-plant cannabis extracts can improve intractable neurogenic symptoms. Clin Rehabil. Feb. 2003;17(1):21-9. cited by applicant |
| Primary Examiner: | Kim, Jennifer M |
| Attorney, Agent or Firm: | Wolf, Greenfield & Sacks, P.C. |
| Accession Number: | edspgr.09895342 |
| Database: | USPTO Patent Grants |
| Language: | English |
|---|