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Originally GW hoped to market cannabis-based prescription medicines by 2004, but is now planning for a launch in the UK towards the end of 2003. Several trials for GW’s cannabis derivatives have also been completed, including four randomised, double-blind, placebo-controlled phase III clinical trials conducted in the UK. The trials were initiated by GW in April 2002, to investigate the use of a sublingual spray containing THC:CBD (narrow ratio) in the following medical conditions: pain in spinal cord injury, pain and sleep in MS and spinal cord injury, neuropathic pain in MS and general neuropathic pain (presented as allodynia). Results from these trials show that THC:CBD (narrow ratio) caused statistically significant reductions in neuropathic pain in patients with MS and other conditions. In addition, improvements in other MS symptoms were observed as well. Phase II studies of THC:CBD (narrow ratio) have also been completed in patients with MS, spinal cord injury, neuropathic pain and a small number of patients with peripheral neuropathy secondary to diabetes mellitus or AIDS. A phase II trial of THC:CBD (broad ratio) has also been completed in a small number of patients with rheumatoid arthritis, as has a trial of High CBD in patients with neurogenic symptoms. A phase II trial has also been evaluated with High THC in small numbers of patients for the treatment of perioperative pain. The phase II trials provided positive results and confirmed an excellent safety profile for cannabis-based medicines. GW Pharmaceuticals received an IND approval to commence phase II clinical trials in Canada in patients with chronic pain, multiple sclerosis and spinal cord injury in 2002. Following meetings with the US FDA, Drug Enforcement Agency (DEA), the Office for National Drug Control Policy, and National Institute for Drug Abuse, GW was granted an import license from the DEA and has imported its first cannabis extracts into the US. Preclinical research with these extracts in the US is ongoing.
Rog DJ, Nurmikko TJ, Young CA. Rog DJ, et al. Clin Ther. 2007 Sep;29(9):2068-79. doi: 10.1016/j.clinthera.2007.09.013. Clin Ther. 2007. PMID: 18035205 Clinical Trial.
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Langford RM, Mares J, Novotna A, Vachova M, Novakova I, Notcutt W, Ratcliffe S. Langford RM, et al. J Neurol. 2013 Apr;260(4):984-97. doi: 10.1007/s00415-012-6739-4. Epub 2012 Nov 21. J Neurol. 2013. PMID: 23180178 Clinical Trial.
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Navarrete C, García-Martín A, Rolland A, DeMesa J, Muñoz E. Navarrete C, et al. Int J Mol Sci. 2021 Mar 15;22(6):2992. doi: 10.3390/ijms22062992. Int J Mol Sci. 2021. PMID: 33804243 Free PMC article. Review.
Brunetti P, Pichini S, Pacifici R, Busardò FP, Del Rio A. Brunetti P, et al. Medicina (Kaunas). 2020 May 15;56(5):237. doi: 10.3390/medicina56050237. Medicina (Kaunas). 2020. PMID: 32429074 Free PMC article. Review.
Al-Ghezi ZZ, Miranda K, Nagarkatti M, Nagarkatti PS. Al-Ghezi ZZ, et al. Front Immunol. 2019 Aug 21;10:1921. doi: 10.3389/fimmu.2019.01921. eCollection 2019. Front Immunol. 2019. PMID: 31497013 Free PMC article.
Kim A, Kaufmann CN, Ko R, Li Z, Han BH. Kim A, et al. J Palliat Med. 2019 Oct;22(10):1196-1201. doi: 10.1089/jpm.2018.0529. Epub 2019 Mar 25. J Palliat Med. 2019. PMID: 30909786 Free PMC article.
Cone EJ, Bigelow GE, Herrmann ES, Mitchell JM, LoDico C, Flegel R, Vandrey R. Cone EJ, et al. J Anal Toxicol. 2015 Sep;39(7):497-509. doi: 10.1093/jat/bkv070. Epub 2015 Jul 2. J Anal Toxicol. 2015. PMID: 26139312 Free PMC article.