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news.360 patients have been recruited across 14 countries in North America, Europe, Latin America and South Africa
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GW Pharmaceuticals (GW) has completed patient enrollment in its Sativex Phase II/III cancer pain trial. The study is being carried out in collaboration with Otsuka Pharmaceutical (Otsuka), GW’s US licensing partner, as part of the US development programme for Sativex.
In the trial, 360 patients have been recruited across 14 countries in North America, Europe, Latin America and South Africa. Patients enrolled in this study have advanced cancer and a clinical diagnosis of cancer-related pain, which is not wholly alleviated with their current strong opioid treatment.
The primary objective of the study is to evaluate the optimum dose range of Sativex in these patients as an adjunct to their pre-existing pain medications. The primary endpoint of the study is the response rate for patients at the end of five weeks of therapy, as defined by a 30% or greater reduction in the 0-10, Numeric Rating Scale (NRS).
GW is conducting its first major trial in collaboration with Otsuka as part of the development program aimed at securing regulatory approval for Sativex from the FDA. The current US development program anticipates two further Phase III trials prior to a subsequent submission of a New Drug Application to the FDA.
Reportedly, GW and Otsuka have already commenced preparation for these two trials with an aim to start soon, following receipt of the Phase IIb/III trial data, and further discussions with FDA.
Nathaniel Katz, former chair of the FDA Pain Advisory Committee and Adjunct Assistant Professor of Anesthesia at Tufts University School of Medicine, said: “GW and Otsuka deserve congratulations for successfully recruiting this number of patients in such a challenging clinical trials area. This study is one of the largest ever conducted in this patient population and we look forward to the results with great interest and excitement.”
The Sativex cancer pain clinical program is being funded by Otsuka under the terms of the US license agreement with GW. Data from these trials will also be available to GW for submission to regulatory authorities in Europe and elsewhere, said the company.