Fibromyalgia Support Group for Surrey and Sussex

Severe blow for millions of Fibromyalgia Syndrome sufferers as European Medicines Agency rejects first drug approval

Press Release from FibroAction 27 October 2008

Millions of chronically ill patients across Europe have received a severe knock-back with the announcement that that the European Medicines Agency has rejected the application of the first medicine, Duloxetine hydrochloride, trying to get EU approval as a treatment for Fibromyalgia Syndrome (Fibro).

Duloxetine already has approval by the American Food and Drug Administration (FDA) for the treatment of Fibro and it has been authorised by the European Medicines Agency (EMEA) since December 2004 as a treatment for other conditions, including painful diabetic neuropathy and episodes of major depression.

Pharmaceutical companies Eli Lilly and Boehringer Ingelheim wanted Duloxetine to be officially indicated as a treatment for Fibro, so that they could market it for this purpose.

This change was refused, despite numerous trials concluding that the drug was safe and efficacious in reducing symptoms of Fibro and that the drug’s effect on Fibro symptoms is independent of its effect on depression (Russell et al, 2008; Arnold et al, 2005; etc).

Fibro is a debilitating, painful chronic condition which affects between 1.2 and 2.7 million people in the UK alone. Despite an increasing body of evidence that Fibro is a real, physical condition related to Central Nervous System dysfunction, there are still medical professionals who refuse to admit the evidence and say that Fibro is a not a real condition. Voluntary organisations across Europe suspect that these outdated views may have had an impact on the Duloxetine decision.

“FibroAction are disappointed to learn of the refusal to allow the clinical indications of Duloxetine to be extended to include Fibromyalgia Syndrome” said Lindsey Middlemiss, founder and chair of FibroAction. “We hope that outdated views of Fibro were not a factor in this decision and that the evidence was considered without an unfair bias. The millions of sufferers across Europe desperately need the help that a properly approved drug would bring.” The refusal is likely to perpetuate the myth that because no drugs have marketing approval in the EU for Fibromyalgia Syndrome, there are no treatments available for the condition.

Because Duloxetine already has EMEA authorisation, it is available on prescription if a doctor considers that it is an appropriate treatment. This is also true of many other treatments for Fibro, some of which are already widely used.

For more information see www.fibroaction.org