Salisbury, United Kingdom: Representatives of the British biotechnology firm GW Pharmaceuticals filed a request this week with European and UK drug regulators for approval of Sativex, an oral spray consisting of natural cannabis extracts, for the symptomatic treatment of Multiple Sclerosis (MS). Sativex is currently available by prescription in Canada and on a limited basis in Spain and Great Britain for patients suffering from neuropathic pain, Multiple Sclerosis, and other conditions.
Regulators from the United Kingdom, Denmark, Spain, and the Netherlands will review the request, which includes clinical data on the use of Sativex in nearly 700 patients with MS. In clinical trials, Sativex has been demonstrated to alleviate numerous MS-associated symptoms compared to placebo, including pain, muscle spasms, and bladder incontinence.
British drug regulators will consult with officials from each of the three countries before rendering a decision. If the UK endorses the drug, it will receive simultaneous regulatory approval from all three nations.
GW officials initially sought to gain approval for Sativex in 2003, but were told by British drug regulators that further clinical evidence of the drug’s efficacy was necessary before they would consider approving it for licensing in the UK.
Separate clinical trials investigating the use of Sativex for the treatment of peripheral neuropathic pain and cancer pain are ongoing.
For more information, please visit: http://www.gwpharm.com.