Results From Two Remaining Sativex Phase 3 Cancer Pain Trial

A cannabis derived drug which has been approved in some countries to treat muscle spasticity.
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Results From Two Remaining Sativex Phase 3 Cancer Pain Trial

Post by enix150 » Fri Dec 11, 2015 2:48 pm ... rials.html
- 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 FDA to discuss clinical relevance of U.S. data and potential paths forward -

LONDON and PRINCETON, N.J., Oct. 27, 2015 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (NASDAQ:GWPH) (AIM:GWP) ("GW") and Otsuka Pharmaceutical Development & Commercialization, Inc. ("Otsuka"), today reported top-line results from the remaining two Phase 3 trials for the investigational product Sativex® in the treatment of pain in patients with advanced cancer who experience inadequate analgesia during optimized chronic opioid therapy. Consistent with the previously reported Phase 3 trial, Sativex did not meet the primary endpoint in these trials. However, a pre-specified pooled analysis of patients across the two Phase 3 trials which involved clinical sites in the U.S. showed a statistically significant improvement for Sativex compared with placebo (p=0.024), with several secondary efficacy endpoints exhibiting p-values of less than 0.05. GW and Otsuka have submitted a request to meet with the U.S. Food and Drug Administration (FDA) to discuss the clinical relevance of these data and to determine potential paths forward.

"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 Justin Gover, GW's Chief Executive Officer. "We believe that this finding may provide important guidance in determining the optimal target patient population for Sativex and look forward to a discussion with the FDA on a potential path forward."

"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. Marie Fallon, Professor of Palliative Care, University of Edinburgh and a principal investigator in the Phase 3 program. "In particular, the U.S. patients enrolled in this program showed a useful therapeutic benefit whereas results in European patients were generally not favorable. These U.S. patients were less frail, hence the Sativex intervention was subjected to less "noise," providing clearer results and valuable guidance in determining the optimal target patient population for Sativex. This is a patient population with a significant unmet need and I believe that this important observation for Sativex warrants further investigation."

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