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EU Equivalent of FDA Fails to Recommend Approval of Cymbalta as Fibromyalgia Drug

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Oct 23, 2008 – Cymbalta/Xeristar (generic name duloxetine, ) – the second drug in the U.S. to receive FDA approval for the treatment of Fibromyalgia in June 2008 – received a “negative opinion” on its authorization as a treatment for FM with & without depression from the Committee for Medicinal Products for Human Use. Within the European Medicines Agency, this committee is responsible for assessing products for which community-wide marketing authorization is sought.

Cymbalta/Xeristar has been authorized in Europe since 2004 as a treatment for major depression, diabetic neuropathy pain, and generalized anxiety disorder. Under other names it is also authorized for use in stress urinary incontinence. The use for FM would be an “extension of indication.” It is delivered in a “gastroresistent” capsule that protects it from being broken down by stomach acid so that it can reach the intestine.

Cymbalta is believed to raise levels of the neurotransmitters serotonin and noradenalin (by blocking their “re-uptake”) in the spaces between nerve cells of the spinal cord and brain – thereby improving cell-to-cell communication. Trials of the drug as a treatment for fibromyalgia focused on measuring its ability to improve symptoms – especially pain levels – and overall health status.

In reviewing the results of 5 clinical studies of Cymbalta, the Committee for Medicinal Products for Human Use:
• Expressed concern that the drug’s effect on symptoms of FM was modest, and could be owing to an improvement in mood.
• Stated that on this basis the demonstrated benefits for FM patients did not outweigh its risks.
• Suggested that a long-term placebo controlled study would be needed to better determine the drug’s effectiveness.

The drug makers may respond with a request that the opinion be re-visited, but reportedly have indicated they have no long-term European trials planned at this time.

 

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