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.
- Increased 5-Year Survival Rate Seen in NSCLC Subset Treated With Nivolumab
- Health Care Expansion Tied to Increased Rates of Surgical Treatment of Thyroid Cancer
- Including a PI3-Kinase Inhibitor with an PARP Inhibitor Improves Tumor Shrinkage in Patients with Resistant Ovarian Cancer
- JAK1, JAK2 Inhibition Improves Outcomes in Myeloproliferative Neoplasms, But More Is Needed
- Hormone Refractory Prostate Cancer Responds to Abiraterone Acetate in Some Cases
- Exercise, Psychological Interventions Better for Cancer Fatigue Than Medications
- ASCO Issues Global Guidance for HPV Vaccination for Cervical Cancer Prevention
- Discharge Events Improved With Standardized Inpatient Palliative Care Consultation
- Little Opposition to Early Palliative Care for Symptom Management in Pediatric Oncology
- Physical Activity Improves Outcomes for Patients with Breast Cancer and Survivors
- CQGS Releases Standards for Surgical Care of Older Adults
- Radiation Protocol Deviations Linked to Worse Outcomes in Pediatric Brain Malignancy
- Use of Counseling, Surgery Rates Show Limited Physician Knowledge of Breast Cancer Genetic Testing
- Family History Does Not Exclude Active Surveillance as Treatment Option for Prostate Cancer
- Beans, Whole Grains in Diet Beneficial for Colorectal Cancer Survivors
Sign Up for Free e-newsletters
Regimen and Drug Listings
GET FULL LISTINGS OF TREATMENT Regimens and Drug INFORMATION
|Head and Neck Cancer||Regimens||Drugs|