- Consistent with previously announced results from the initial Phase 3 trial, remaining trials fail to show superiority over placebo -
- Pre-specified subgroup analyses of pooled U.S. patients demonstrated a statistically significant result for the primary endpoint and a number of secondary endpoints -
- GW and Otsuka have submitted a request to meet with
"In light of the missed primary endpoint in the first trial earlier this year, these additional results are not a surprise. Nevertheless, we are encouraged by data across the trials which consistently show positive outcomes for U.S. patients when analysed as a separate cohort," stated
"While the results overall have been disappointing, and not necessarily wholly consistent with clinical experience, nonetheless they suggest that Sativex may have a useful role in the treatment of certain subgroups of patients with advanced cancer pain who have exhausted opioid treatments," stated Dr.
Trial 2 Efficacy
This randomized, double-blind, placebo-controlled, parallel-group study was identical in design to the previously reported Phase 3 trial. The trial recruited a total of 397 patients at clinical sites in the U.S.,
The primary efficacy measure of this study was a patient assessment of pain using a 0-to-10 Numeric Rating Scale (NRS) which was analysed using percent improvement from baseline as the primary analysis. In addition, improvement was also analysed using a cumulative-proportion-of-responders analysis, which analyses the full range of responses achieved across the entire patient population within a trial.
In this trial, the primary endpoint was in favour of Sativex and approached statistical significance for the intention-to-treat (ITT) population (p=0.085). The secondary endpoints followed the pattern of the primary endpoint with a significant reduction seen in sleep disruption (p=0.027) and a number of other endpoints approaching statistical significance.
In this study, the U.S. was the largest single recruiting country, with patients from the U.S. representing 30 percent of the overall trial population. The efficacy data from U.S. sites alone showed more positive trends than those in non-U.S. sites, which is consistent with data from the first Phase 3 trial and the Phase 2b trial.
In pre-specified pooled analyses of both this trial and the previously reported Phase 3 trial, which had an identical design, patients at clinical sites in the U.S. (n=248) demonstrated a statistically significant result for the primary endpoint (p=0.024) as well as a number of secondary endpoints including subject global impression of change (p=0.0004) and physician global impression of change (p < 0.0001).
Trial 3 Efficacy
A third study, which was conducted entirely outside the U.S. and which used a different clinical design, failed to show separation from placebo on the primary endpoint.
The safety profile of Sativex in the clinical development program in treatment of pain in patients with advanced cancer who experience inadequate analgesia during optimized chronic opioid therapy was consistent with the known effects of Sativex and with the clinical profile of this specific patient population. The only adverse event (apart from progression of the underlying cancer) reported at greater than 10 percent for the Sativex population was nausea (15.6% Sativex vs 10.6% placebo in Trial 2).
All three Sativex Phase 3 studies were carried out by GW and Otsuka as part of the development program aimed at securing regulatory approval for Sativex in cancer pain.
OPDC is a subsidiary of
GW is a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform in a broad range of disease areas. In 17 years of operations, GW has established a world leading position in the development of plant-derived cannabinoid therapeutics through its proven drug discovery and development processes, intellectual property portfolio and regulatory and manufacturing expertise. GW commercialized the world's first plant-derived cannabinoid prescription drug, Sativex®, which is approved for the treatment of spasticity due to multiple sclerosis in 27 countries outside
This news release contains forward-looking statements that reflect GW's current expectations regarding future events, including statements regarding financial performance, the timing of clinical trials, the relevance of GW products commercially available and in development, the clinical benefits of Sativex® and the safety profile and commercial potential of Sativex. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including (inter alia), the success of GW's research strategies, the applicability of the discoveries made therein, the successful and timely completion of uncertainties related to the regulatory process, and the acceptance of Sativex, Epidiolex and other products by consumer and medical professionals. A further list and description of risks and uncertainties
associated with an investment in GW can be found in GW's filings with the
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