Sativex No Better than Placebo for Cancer Pain in Trial, but Manufacturers Still Hopeful

The gist: A cancer pain drug called Sativex was not found to be any better than a placebo in a recent clinical trial. However, the makers of the drug are still optimistic about it, based on previous successful studies. They will continue to test it to see whether they can get better results.

“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. In this first trial, Sativex (as adjunctive treatment to optimized chronic opioid therapy) did not meet the primary endpoint of demonstrating a statistically significant difference from placebo.

” ‘Although we missed the primary endpoint in this trial, based upon the positive data seen in the Phase 2 program, we remain confident in the ability for Sativex to relieve cancer pain in this patient population’, stated Justin Gover, GW’s Chief Executive Officer. ‘We have two additional pivotal Phase 3 trials ongoing which, if positive, would still allow us to submit a New Drug Application with the US FDA. We look forward to results from these two further studies later this year.’ “


Race Affects Opioid Selection for Cancer Pain

“Racial disparities exist in the type of opioid prescribed for cancer pain, according to a study published online July 21 in the Journal of Clinical Oncology.

“Salimah H. Meghani, Ph.D., R.N., from the University of Pennsylvania in Philadelphia, and colleagues recruited 182 patients from clinics within a single health system. All participants reported the presence of cancer-related pain plus a prescription for morphine or oxycodone. The abbreviated Modification of Diet in Renal Disease formula was used to estimate kidney function.

“The researchers found that the severity of analgesic-related adverse effects was greater for patients with chronic kidney disease (CKD) who received morphine versus oxycodone (P = 0.010). Compared with white patients, African-American patients had 71 percent lower odds of receiving a prescription of oxycodone (P < 0.001), when controlling for health insurance type. The effect of private insurance was no longer significant on limiting the analysis to patients with CKD, but race remained a significant predictor of the prescribed opioid selection. In the presence of CKD, race was a strong predictor for adverse effect severity, and this association was partially mediated by the type of opioid selection.”


Promising Medication Counteracts Constipation Caused by Opioid Painkillers

“Up until a decade ago, physicians rarely prescribed opioids, reserving them primarily for the terminally sick. Today, opioid-based drugs have proliferated thanks to their ‘user-friendliness’ and effectiveness. Millions of patients take opioids on a daily basis to manage lower back pain and chronic joint problems. Opioids also play a critical role in pain management regimes for cancer patients.

“However, opioids have a number of side effects, including nausea, vomiting and — notoriously — constipation. Opioids block pain by binding to ‘mu-receptors’ in the brain. But they also bind to mu-receptors in the bowels, and this causes constipation.

“Some sixty percent of patients that take opioid pain relievers experience constipation. For some, the bother is so great that they choose to stop taking the drug…

“A newly developed opioid antagonist called naloxegol may offer relief. Stage 3 testing by an international team of researchers led by Belgian gastroenterologist Jan Tack (University Hospitals Leuven) confirms the drug’s efficacy.”


Steroids in Advanced Cancer Don't Help Pain But Boost QOL

The gist: A clinical trial with volunteer patients tested a potentially pain-relieving treatment for people with advanced cancer. The treatment combines opioid therapy (a standard treatment for pain) with a drug called methylprednisolone. The researchers found that the addition of methylprednisolone to opioid therapy did not lessen pain compared to opioid therapy alone, but it boosted quality of life—”less fatigue, better appetite, and better overall satisfaction with their treatment.”

“For patients with advanced cancer, the addition of methylprednisolone to opioid therapy did not help control pain, but it did boost quality of life, according to results from a small randomized trial. Patients who received the corticosteroid reported less fatigue, better appetite, and better overall satisfaction with their treatment than those who did not.

“In the study, patients who received methylprednisolone 16 mg twice daily for 7 days had a lower pain-intensity score (measured on a 10-point scale) than those who received placebo (mean difference, –0.08; P = .88).

“There was no significant difference in pain intensity between the groups at baseline (mean difference, –0.48; P = .50), and no difference in opioid use.

“The study was published online July 7 in the Journal of Clinical Oncology.”