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

The millions of Fibromyalgia Syndrome sufferers across Europe have this week received a severe knock-back with the announcement that that the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMEA) has rejected the application of the first medicine, Duloxetine hydrochloride, trying to get approval as a treatment for Fibromyalgia Syndrome (Fibro) in the EU.

Earlier this year Duloxetine was the second medicine to get approval by the Food and Drug Administration (FDA) in the USA for the treatment of Fibro. Pfizer’s Lyrica (Pregabalin) was the first drug to get FDA approval in the USA for the treatment of Fibro in 2007.

Duloxetine has been authorised by the EMEA since December 2004 and is used for the treatment of adults with episodes of major depression, pain due to diabetic peripheral neuropathy, generalised anxiety disorder and stress urinary incontinence.

Pharmaceutical companies Eli Lilly and Boehringer Ingelheim (who would market the drug as Cymbalta and Xeristar respectively) applied for a change to the marketing authorisation so that Duloxetine could be officially indicated as a treatment for Fibromyalgia Syndrome and marketed for this purpose.

The CHMP refused this change, citing as reasons that they were concerned that the effectiveness of Cymbalta/Xeristar (Duloxetine) in treating Fibro had not been shown sufficiently, and that at that point in time, they were of the opinion that the benefits of Cymbalta/Xeristar (Duloxetine) in the treatment of Fibro did not outweigh its risks. The CHMP stated that their concern about the lack of effectiveness of the drug was because the “modest effects” could be due to the medicine’s effect of improving the patients’ mood. However a number of trials of Duloxetine as a treatment for Fibro have concluded that the drug’s effect on Fibro symptoms is independent of its effect on depression (Russell et al, 2008; Arnold et al, 2005; etc). The conclusion of multiple trials was that the drug was safe and efficacious in reducing symptoms of Fibro.

The European Network of Fibromyalgia Associations issued a press release yesterday saying that “it is suspected that the misperception, even among some medical professionals, in Europe that [Fibro] is not a real medical condition must have contributed to the decision”.

Despite an increasing body of evidence that Fibro is a real, physical condition that is not psychosomatic in nature, but is related to Central Nervous System (CNS) dysfunction, there are still medical professionals who refuse to admit the evidence and say that Fibro is a not a real condition.

Fibro is a debilitating, chronic condition whose main symptoms are widespread chronic pain, hypersensitivity to pain and chronic fatigue. Despite the high numbers of sufferers (between 1.2 and 2.7 million people in the UK alone), awareness of the condition, and the knowledge and treatments available for it, is very low, even amongst medical professionals, and many patients are left to suffer alone.

The EU marketing approval for Duloxetine and future drugs to apply is needed because, without it, pharmaceutical companies are unable to promote their products as treatments for Fibro. This product promotion has been seen in the USA to significantly raise awareness of the condition, and of the fact that there are treatments available for it, something that is desperately needed.

“FibroAction are disappointed to learn of the refusal by the CHMP 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 Fibromyalgia Syndrome were not a factor in this decision and that the evidence was considered without an unfair bias. The millions of people with Fibromyalgia Syndrome across Europe desperately need the help that a properly approved drug would bring and we hope that the CHMP will shortly be indicating a positive opinion about other treatments for the condition.”

The negative response from the CHMP 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.

References:

1. Russell, IJ, et al. Efficacy and Safety of Duloxetine for Treatment of Fibromyalgia in Patients With or Without Major Depressive Disorder: Results From A Six-Month, Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose Trial, Pain. 2008.
2. Arnold, L, et al. A Randomized, Double-Blind, Placebo Controlled Trial of Duloxetine in the Treatment of Women with Fibromyalgia With or Without Major Depressive Disorder. Pain. 2005; 119 (1-3): 5-15
3. Arnold, L, et al. A Double-Blind, Multicenter Trial Comparing Duloxetine with Placebo in the Treatment of Fibromyalgia Patients With or Without Major Depressive Disorder. Arthritis Rheum 2004; 50(9):2974-84.