Oct 23, 2008: Cymbalta/Xeristar – the second drug to receive FDA approval for treatment of fibromyalgia – has not been recommended for treatment of FM in Europe. The Committee for Medicinal Products for Human Use, which advises the European Medicines Agency on approvals of drugs for community-wide marketing authorization, has issued a negative opinion on this indication.
Cymbalta/Xeristar has been approved since 2004 in the EU for treatment of major depression, pain of diabetic peripheral neuropathy, and generalized anxiety disorder, and under other names has been approved as a therapy for stress urinary incontinence.
The drug is believed to work by raising levels of the neurotransmitters serotonin and noradrenaline in the spinal cord and brain (by blocking their re-uptake), thereby supporting cell-to-cell communication. These neurotransmitters are thought to play a role in fibromyalgia, and trials of Cymbalta/Xeristar have focused on measuring improvement of FM symptoms with a focus on pain, in patients with and without depression.
The CHMP expressed concern that the improvement demonstrated in FM trials was modest, might be owing to the drug’s effect on mood, and as such did not outweigh the drug’s risks. It suggested that a long-term placebo controlled trial would be needed.
The drug’s makers have the opportunity to request a re-examination of the opinion, and have not indicated plans for a long-term controlled trial in the EU.