First of three phase 3 cancer pain trials shows disappointing results

Share this content:

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.

Managing peripheral neuropathy
Patients with advanced cancer often do not attain adequate pain relief from optimized chronic opioid therapy.
GW Pharmaceuticals plc and Otsuka Pharmaceutical Development & Commercialization, Inc., have reported the top-line results from the first of three 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.
READ FULL ARTICLE From Medical News Today
You must be a registered member of ONA to post a comment.

Sign Up for Free e-newsletters

Regimen and Drug Listings


Bone Cancer Regimens Drugs
Brain Cancer Regimens Drugs
Breast Cancer Regimens Drugs
Endocrine Cancer Regimens Drugs
Gastrointestinal Cancer Regimens Drugs
Genitourinary Cancer Regimens Drugs
Gynecologic Cancer Regimens Drugs
Head and Neck Cancer Regimens Drugs
Hematologic Cancer Regimens Drugs
Lung Cancer Regimens Drugs
Other Cancers Regimens
Rare Cancers Regimens
Skin Cancer Regimens Drugs