By Jeanne Hambleton © 2008
News that the drug Cymbalta/Xeristar, a medicine containing the active substance duloxetine, will not be approved in Europe as the first official drug to treat fibromyalgia has been announced, causing grave concern to those who suffer with pain 24/7. This has led to fears that the decision may lead to more delays in a UK approval of new drugs to bring relief to fibromyalgia patients. There are currently no approved drugs for the treatment of Fibromyalgia available to UK patients.
This follows news that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency have adopted a negative opinion, recommending the refusal of a change to the marketing authorisation for the medicinal product Cymbalta/Xeristar 30 mg and 60 mg gastroresistant capsules for treatment of Fibromyalgia.
Cymbalta is the first medication for Fibromyalgia treatment that has been filed in Europe by Eli Lilly for the treatment of this invisible disability. The medicine was approved by the US Food and Drug Administration (FDA) for Fibromyalgia in June 2008.
The European Network for Fibromyalgia Associations suspect that the misperception, even among some medical professionals in Europe, that fibromyalgia is not a real medical condition may have contributed to the decision. Despite the fact that the World Health Organisation (WHO) has recognized Fibromyalgia as a disease in 1992, and several well respected medical organizations including the European League Against Rheumatism (EULAR), the American College of Rheumatology and the American Pain Society (APS) have developed criteria and guidelines for the classification and treatment of fibromyalgia, some medical professionals and some governments in Europe have been slow to recognise Fibromyalgia as a disease.
Cymbalta/Xeristar is a medicine containing the active substance duloxetine. It is available as gastroresistant capsules. Cymbalta/Xeristar was authorised for this purpose in December 2004. It is also used for adults with major depression; pain due to diabetic peripheral neuropathy (damage to the nerves in the extremities that can occur in patients with diabetes); and generalised anxiety disorder (long-term anxiety or nervousness about everyday matters).
In the European Medicines Agency press release from Canary Wharf, London, it states the major concerns that led the committee to recommend the refusal of the change to the marketing authorisation, came from concern that the effectiveness of Cymbalta/Xeristar in treating fibromyalgia had not been shown sufficiently. The results of five studies involving a total of 1,718 adults with fibromyalgia were submitted to the CHMP. Four of these were short term and one long term involving 307 patients.
In the short-term studies, the CHMP considered that the effect of Cymbalta/Xeristar was too small to be relevant for patients. There was no clear demonstration of improvement in symptoms and the modest effects of Cymbalta/Xeristar could be due to the medicine’s effect of improving the patients’ mood. The CHMP also concluded that the long-term study was insufficient to show the effectiveness of the medicine and that a long-term study comparing Cymbalta/Xeristar with placebo would be needed.
The CHMP was of the opinion that the benefits of Cymbalta/Xeristar in the treatment of fibromyalgia did not outweigh its risks and recommended that the change to the marketing authorisation be refused.
Mr. Robert Boelhouwer, President of the European Network for Fibromyalgia Associations (ENFA), expressed his concern following months of work in Brussels with the European Parliament to raise awareness, establishing a declaration for acceptance by the ENFA countries and promoting a petition for the recognition of Fibromyalgia.
He said, “The ENFA encourages the regulatory agency and its professional committee members to recognise the sufferings that the patients have been enduring and approve other effective and safe treatment options as soon as possible. This negative recommendation has put the 14 million Fibromyalgia patients in Europe in despair. They have been hoping to have access to the first innovative medicine to treat their disease. I cannot believe that Fibromyalgia patients in Europe cannot have an access to the medicine that has been helping the patients in the US and other countries in the world.”
The latest ENFA press release suggests that the misperception even among some medical professionals in Europe that fibromyalgia is not a ‘real’ medical condition may have contributed to the decision. Despite the fact that the World Health Organisation (WHO) has recognised Fibromyalgia as a disease in 1992, and several well respected medical organisations including the European League Against Rheumatism (EULAR), the American College of Rheumatology and the American Pain Society (APS) have developed criteria and guidelines for the classification and treatment of fibromyalgia, some medical professionals and some governments in Europe have been slow to recognise Fibromyalgia as a disease.
The ENFA claim it is estimated that about 12-14 million people in Europe suffer from fibromyalgia and the epidemic is more prevalent with women (87% of total prevalence). Due to the complex pathology of the disease, a comprehensive diagnosis requires multi-disciplinary approach. A recent global survey showed that healthcare professionals lack confidence in diagnosing and managing Fibromyalgia. Educating healthcare professionals, patients and the public to promote better understanding and management of Fibromyalgia will benefit patients, healthcare providers and the society. Some scientists believe that there is an abnormality in how the body responds to pain, and particularly a heightened sensitivity to stimuli.
Currently, two medicines have been approved in the US to treat Fibromyalgia. The US Food and Drug Administration, the equivalent of the EMEA in Europe, has approved the first medicine Lyrica (pregabalin) in June 2007 for specifically treating fibromyalgia and Cymbalta (duloxetine hydrochloride) in June 2008. Both Lyrica and Cymbalta are proven to reduce pain and to improve function in people with Fibromyalgia.
Fibromyalgia imposes large economic burdens on the society as well as on affected individuals. A study shows that an average patient in Europe consults up to seven physicians and takes multiple medications over 5-7 years before receiving the correct diagnosis. The debilitating symptoms often result in lost work days, lost income and disability payments. In fact, a Dutch study in 2005 estimates that the average annual cost of fibromyalgia is €980 million in the Netherlands. Research in the UK has shown that diagnosis and positive management of Fibromyalgia reduce healthcare cost by avoiding unnecessary investigations and consultations
The ENFA describes Fibromyalgia as a complex disease with chronic widespread pain as the defining symptom and various additional symptoms including fatigue, non-restorative sleep, morning stiffness, irritable bowel and bladder, restless legs, depression, anxiety and cognitive dysfunction often referred to as “fibro fog.” All of these symptoms cause serious limitations in patients’ ability to perform ordinary daily chores and work and severely affect their quality of life.
As with all new medication the patient’s information leaflet and details of potential side effects should be read before taking any medication.