The UK's GW Pharmaceuticals has won FDA approval to launch a Phase III trial of its cannabis-based Sativex as a treatment for the pain experienced by cancer patients. The 250-patient trial is expected to get underway in the latter part of this year, with data for the FDA expected in two or three years. GW said that it will now seek a licensing partner in the US to underwrite much of the cost of the new trial. GW also reported that it had raised $15 million through a private share placement.
Sativex has been approved in Canada for patients suffering from multiple sclerosis. In addition, Sativex has completed a successful Phase III trial in Europe for advanced cancer pain. "GW has been planning carefully its approach to the US market for a number of years and has established a group of prominent US advisers and experts to assist its efforts," said GW chairman Dr Geoffrey Guy.
- read this report from the Telegraph for more information