Cannabis-based Multiple Sclerosis drug, Sativex, shows long-term efficacy
08 September 2008
GW Pharmaceuticals Plc announced today that a study of its cannabis-based pain killer Sativex has shown long-term efficacy in the treatment of neuropathic pain due to multiple sclerosis.
It is the first time that the long-term effectiveness of the drug had been demonstrated in a so-called placebo-controlled study, where it is tested against a dummy drug.
The news is also significant for the company because it bolsters hopes that it might gain approval for the drug as a treatment for spasticity associated with multiple sclerosis, because the trial is very similar to a late-stage trial that has been running at the request of regulators.
Stephen Wright, GW's R&D Director, said in a statement: "It is encouraging to note that if the difference between Sativex and placebo achieved in the results today are replicated in the ongoing Phase III MS spasticity study, this Phase III study will meet its objectives."
This study is due to report results in the first quarter of 2009 with a regulatory submission planned for the first half of 2009.
Source: Reuters © Thomson Reuters 2008 (08/09/08)
Treatment: Gilenya since 01/2011, CCSVI both IJV ballooned 09/2010, Tysabri stopped after 24 Infusions and positive JCV antibody test, after LDN, ABX Wheldon Regime for 1 year.