The Pharmaceutical Journal
Vol 273 No 7312 p216
14 August 2004

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Patients with multiple sclerosis should be offered cannabinoid when licence approved

Dronabinol, a cannabinoid, should be available as a treatment option to patients with multiple sclerosis whose pain does not respond adequately to other drugs, say researchers from Denmark.

Results of their study show that dronabinol (Marinol, Solvay) has an analgesic effect on neuropathic pain comparable to that of other treatment options available.

A spokesman for Solvay confirmed that Marinol was under investigation for use in patients with multiple sclerosis and that the company hoped to apply for a license for this indication in the future.

The Danish researchers randomised 24 patients with multiple sclerosis and neuropathic pain to either oral dronabinol at a final dose of 10mg per day or placebo for three weeks followed by a 21-day washout period. Patients then switched over for a further three weeks. Before the study the patients all had a pain intensity score of >=3 on a 0–10 numerical scale (0 = no pain, 10 = worst pain imaginable).

Patients who had used marijuana within the previous three months, or who were unwilling to stop using marijuana during the study period, were excluded.

Pain intensity was assessed twice daily, and pain relief was assessed at the end of each treatment period. The researchers found that the median spontaneous pain intensity during the last week of treatment was lower during dronabinol treatment than during treatment with placebo (4.0 versus 5.0, P=0.02), and median pain relief score was higher during dronabinol treatment (3.0 versus 0, P=0.035). The number needed to treat for 50 per cent pain relief was 3.5 (95 per cent confidence interval 1.9 to 24.8).

The researchers say: “Whether the small reduction in pain intensity we found is clinically important could be debated. However, the pain reduction seen during treatment with dronabinol in this study is comparable to the effect of other drugs used in the treatment of neuropathic pain.”

Adverse events were reported in 23 patients (96 per cent) taking dronabinol, the most common being dizziness, headache and tiredness (BMJ 2004;329:253).