Sativex showed positive results in Phase II placebo-controlled trial in treating pain due to rheumatoid arthritis (RA). RA is the commonest form of inflammatory arthritis and afflicts up to 3% of the population of Western countries. In this 56 patient study, statistically significant improvements in favour of Sativex were found for pain on movement, pain at rest, quality of sleep, and DAS28 scores. The DAS28 is the present gold standard inflammation activity measure and this result suggests an effect on the progression of the disease itself.
Ninety per cent of people with multiple sclerosis (MS) develop lower urinary tract symptoms after 10 years of disease activity. A Phase II trial with 135 patients with advanced MS who were experiencing bladder dysfunction demonstrated a significant effect with the use of Sativex. It achieved statistically significant improvements in a range of bladder symptoms, including nocturia (p=0.01), daytime frequency (p=0.044), frequency per 24 hours (p=0.001), and bladder symptom severity (p=0.001). A significant effect was also seen in the patient’s global impression of change (p=0.005). There was also a strong trend in favour of Sativex in urgency (p=0.07). The findings of this study are supported by a previous open-label pilot study with 21 people suffering from MS, Sativex produced sustained improvement in urinary symptoms, in particular urinary urgency and incontinence, with significant improvements in symptom specific quality of life scores. Participants reported improvements in pain, spasticity and quality of life and unpleasant side effects were uncommon.
Under a programme sponsored by the Government of Catalonia in Spain, Sativex was prescribed to patients with the following therapeutic concerns:
- Neuropathic pain due to MS, Spaciticity due to MS
- Neuropathic pain due to different medical conditions (other than MS),
- Anorexia-cachexia syndrome due to cancer or AIDS, and
- Nausea and secondary vomiting due to chemotherapy treatment.
The study was restricted to patients who were unable to respond to, or unable to tolerate, currently available treatments and whose medical condition and quality of life were considered to be poor. The published results showed that half of the patients who received Sativex responded well by reporting improvement of their symptoms. Patients with MS reported an improvement of their pain and/or their spasticity. Patients with neuropathic pain from other causes also experienced improvement of their pain. The majority of patients with anorexia – cachexia syndrome showed improved appetite and patients undergoing chemotherapy reported an improvement of their nausea and vomiting.
Sativex has also been trialed in two pilot Phase II trials in post-operative pain which have shown encouraging results.