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Nabiximols : ウィキペディア英語版
Nabiximols

Nabiximols (USAN,〔United States Adopted Names Council: (Statement on a nonproprietary name )〕 trade name Sativex) is a specific extract of ''Cannabis'' approved as a botanical drug in the United Kingdom as a mouth spray for multiple sclerosis (MS) patients, who can use it to alleviate neuropathic pain, spasticity, overactive bladder, and other symptoms; it was developed by the UK company GW Pharmaceuticals.〔Multiple Sclerosis Trust. October 2014 (Sativex (nabiximols) - factsheet )〕 The drug is a pharmaceutical product standardised in composition, formulation, and dose. Its principal active cannabinoid components are the cannabinoids: tetrahydrocannabinol (THC) and cannabidiol (CBD). Each spray delivers a near 1:1 ratio of CBD to THC, with a fixed dose of 2.7 mg THC and 2.5 mg CBD. Nabiximols is also being developed in Phase III trials as a potential treatment to alleviate pain due to cancer. It has also been researched in various models of peripheral and central neuropathic pain.
In May 2003 GW Pharmaceuticals and Bayer entered into an exclusive marketing agreement for GW’s cannabis-based medicinal extract product, to be marketed under the brand name Sativex. "Bayer has obtained exclusive rights to market Sativex in the UK. In addition, Bayer has the option for a limited period to negotiate the marketing rights in other countries in European Union and selected other countries around the world."
In April 2011, GW licensed to Novartis the rights to commercialise nabiximols in Asia (excluding China and Japan), Africa and the Middle East (excluding Israel).
==Availability==
In June 2010, the Medicines and Healthcare products Regulatory Agency of the United Kingdom licensed nabiximols as a prescription-only medicine for the treatment of spasticity due to multiple sclerosis. This regulatory authorization represents the world's first full regulatory approval for the medicine. The spray is being marketed in the UK by Bayer Schering Pharma. Many MS patients cannot receive nabiximols due to local National Health Service (NHS) resistance to its funding; but, in August 2014, the NHS in Wales agreed to fund Sativex for people with multiple sclerosis.
Nabiximols was also approved in Spain for MS spasticity in the second half of 2010 and was launched in that country in March 2011. It was approved in the Czech Republic in April 2011, in Germany in May 2011, in Denmark in June 2011 and in Sweden in January 2012 to MS patients who have not responded adequately to other medication for spasticity.〔(Sativex (nabiximols), Swedish Medical Products Agency )〕 It has also been recommended for approval in Italy and Austria with formal approvals expected in these countries during 2011. In Spain and other European markets (excluding the UK), nabiximols will be marketed by Almirall.
In Canada, nabiximols has been approved by Health Canada for the treatment of MS spasticity. It has also received a licence with conditions (NOC/c) for two additional uses: as adjunctive treatment for the symptomatic relief of neuropathic pain in multiple sclerosis,〔GW Pharmaceuticals. "(Multiple Sclerosis )". Accessed 24 July 2011.〕 and also for pain due to cancer.〔GW Pharmaceuticals. "(Cancer Pain )" Accessed 24 July 2011.〕〔

Nabiximols is available in a number of countries as an unlicensed medicine, which enables doctors to prescribe the product to individual patients who they consider may benefit. The product has been exported from the UK to a total of 28 countries to date.
In February 2007, GW and Otsuka Pharmaceutical announced an exclusive agreement for Otsuka to develop and market the drug in the United States. The first large scale US Phase IIb trial, Spray Trial, for cancer patients reported positive results in March 2010. GW and Otsuka have now commenced the Phase III development of nabiximols in cancer pain.
In December 2012, Sativex was approved in Poland.
In 2013, France legalized the use of cannabinoids in medicine, Sativex is the first one to be sold under prescription.〔(【引用サイトリンク】 title=France Legalizes Marijuana-Based Drug To Treat Multiple Sclerosis )

抄文引用元・出典: フリー百科事典『 ウィキペディア(Wikipedia)
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