Cannabis-Based Pain Treatment: SATIVEX
"European authorities asked for two phase III trials of Sativex against neuropathic pain in the same patient group, Salisbury, England-based GW said today. Phase III is the last of three stages generally required for approval. Sativex was delayed by U.K. regulators in June 2005 and has yet to gain approval for spasticity, or stiffness and spasms in multiple-sclerosis patients. GW said in March that it may ask European regulators to approve the medicine before the U.K....``One of the principal purposes of this study is to complete the regulatory package required for the approval in Europe of Sativex in the indication of neuropathic pain in MS,'' said Stephen Wright, the company's head of research.

Sativex was delayed by U.K. regulators in June 2005 and has yet to gain approval for spasticity, or stiffness and spasms in multiple-sclerosis patients. GW said in March that it may ask European regulators to approve the medicine before the U.K.

Shares in GW fell 5.5 pence, or 6.1 percent, to 84.5 pence by 8:45 a.m. in London trading. They rose 17 percent yesterday and have fallen 44 percent this year.

Canadian regulators approved Sativex, administered as a mist sprayed inside the mouth, for use in neuropathic pain caused by nerve damage, in April 2005."