Two New Approaches for Fibromyalgia

Two drugs, which are approved for other indiciations, have recently shown promise in controlled studies in treating the symptoms of fibromyalgia. The first is a marijuana derivative, nabilone (Cesamet®), as reported in the Journal of Pain. Nabilone is GDA-approved for tresting nausea and vomiting induced by chemotherapy. In a 40-patient study, half the patients took nabilone at doses starting at 0.5 mg at bedtime and increased up to 1 mg twice daily, given for 4 weeks. The other 20 patients took a matching placebo. The Fibromyalgia Impact Questionnaire was used to assess the following symptoms: physical function, work status, depression, anxiety, sleep, pain, stiffness, fatigue, and well-being. A separate pain scale was also used.

Both measures showed there were significant improvement with nabilone, compared with the placebo. There were no effects on tender points. Side-effects included dry mouth, drowsiness, vertigo, and confusion. There was no euphoria.

The other report, presented at the American Academy of Pain Medicine meeting, was on duloxetine (Cymbalta®),which is approved by the FDA for treating major depression and anxiety disorders. In a 6-month placebo-controlled study, 60 and 120 mg duloxitine daily were compared with placebo over a 6-month period. Pain scores and an overall assessment of symptoms (Patient Global Impressions of Improvement) were done.

At 3 months there were significant improvements in both assessment measures with both 60 and 120 mg duloxetine daily, compared with placebo. At 6 months, the signifcant improvement was limited to the 120 mg dose level.

The benefits offered by these two new drugs for fibromyalgia will make life easier for many fibromyalgia sufferers, once they are approved by the FDA. In this respect, Cymbalta is further along in the approval process, and is not burdened by being a Class II controlled substance, i.e. a lot harder to get.