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news.GW Pharmaceuticals has initiated Sativex Phase III clinical trials in the treatment of pain in patients with advanced cancer, who experience inadequate analgesia during optimised chronic opioid therapy.
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The Phase III programme is being performed in conjunction with GW Pharma’s licensing partner for Sativex in the US, Otsuka Pharmaceutical.
The programme, which is fully funded by Otsuka, includes two Phase III randomised placebo-controlled multi-centre multinational trials as well as a long term extension study.
Each Phase III trial will include approximately 370 patients and will evaluate the efficacy and safety of Sativex versus placebo over a 5 week treatment period.
The primary efficacy measure of the Phase III trials is a patient assessment of pain using a 0-10 Numeric Rating Scale (NRS), and the primary analysis is the ‘continuous response analysis of percent improvement from baseline’ (an analysis of percent improvement in pain across the spectrum of response levels).
Each of the Phase III trials is expected to recruit patients in Europe, North America, Latin America and Asia. The first Phase III trial site has now been initiated in Europe and the first patient is expected to be recruited during December 2010.
GW Pharma R&D director Stephen Wright said that they are pleased to have arrived at this important milestone in the development of Sativex for cancer pain.
"We have completed two large Phase II trials with positive results and look forward to working with Otsuka on this comprehensive Phase III programme for Sativex in this important indication," Wright said.