First of three phase 3 cancer pain trials shows disappointing results
the ONA take:
Patients with advanced cancer often do not attain adequate pain relief from optimized chronic opioid therapy or experience unacceptable opioid side effects.
Researchers believe that cannabinoid therapy as a co-analgesic may provide pain relief beyond opioid therapy. In a phase 3 trial for the investigational product Sativex, a cannabinoid medicine, topline results show that the primary end point of demonstrating a statistically significant difference from placebo was not achieved.
A total of 399 patients were recruited at clinical sites in the United States, Mexico, and Europe for this randomized double-blind placebo-controlled parallel-group study.
The trial evaluated Sativex at a dose range of 3 to 10 sprays/day over a 5-week period with an additional stabilization period of 5 to 14 days at the beginning of the trial and a 1-week follow-up at the end of the trial.
Participants received Sativex or placebo as adjunctive treatment to optimized chronic opioid therapy and remained on stable doses of their background opioid therapy during the study.
This is the first of three phase 3 trials of this investigational product, and although the researchers are disappointed that the primary end point was not achieved, they are optimistic that results from the other studies will support filing a New Drug Application with the FDA.
Sativex is currently approved in 27 countries outside the United States for the treatment of spasticity due to multiple sclerosis. A request for Special Protocol Assessment has been submitted to the FDA for a proposed single phase 3 study in this indication.
Patients with advanced cancer often do not attain adequate pain relief from optimized chronic opioid therapy.
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