Positive results for Xyrem

Jazz Pharmaceuticals, Inc. and UCB last week announced positive preliminary top-line results from the first of two Phase III pivotal clinical trials of sodium oxybate (JZP-6) for the treatment of Fibromyalgia Syndrome (Fibro).

Jazz Pharmaceuticals anticipates submitting a New Drug Application for sodium oxybate to the U.S. Food and Drug Administration by the end of 2009. UCB anticipates filing in the EU shortly after. UCB has the exclusive marketing and distribution rights to sodium oxybate for Fibromyalgia Syndrome in Europe and some other countries outside North America.

For more information, see the FibroAction article.

 

Spoon Queen Interviews American Idol star

Leslie Hunt talks Lyrics, Life, and Lupus with ButYouDontLookSick.com founder Christine Donato. If you ever wonder how far you can go with a chronic illness, just check out these chronic babes!

Leslie Hunt has been performing as a musician since childhood and by the age of thirteen, Leslie had starred in productions of “Fiddler on the Roof” and “Music Man” and performed on stage with Kenny Rogers. She was in American Idol Season 6 (2007)…and at the age of seven, Leslie was diagnosed with Lupus SLE.

Christine Miserandino, a fellow Lupus patient is a member of the Lupus Alliance of America Board of Directors, and founder of ButYouDontLookSick.com. She is loved the world over for ‘The Spoon Theory’, her tale of what life is really like when you live with a chronic invisible illness.

Check out Christine’s interview with Leslie here.

 

‘Women, Work and AutoImmune Disease: Keep Working Girlfriend’

Rosalind Joffe is author of the popular blog, ‘Working With Chronic Illness’, and co-author of the blog ‘Keep Working Girlfriend’. She founded the career coaching practice, cicoach.com, building on her experiences living and working with MS and ulcerative colitis, and is dedicated to helping others with chronic illness develop the skills they need to succeed in the workplace.

Together with her ‘Keep Working Girlfriend’ blog co-author, Joan Friedlander, Rosalind has written a book ‘Women, Work and AutoImmune Disease: Keep Working Girlfriend’, which encourages women with chronic illness to stay employed to preserve their independence and sense of self, and helps teach them the knowledge and skills they need to do so. In the book, Fibromyalgia Syndrome (Fibro) is included along with autoimmune conditions such as Lupus and Rheumatoid Arthritis, as the impact and variable nature of the conditions are very similar.

I thought ‘Women, Work and AutoImmune Disease: Keep Working Girlfriend’ was a great book: positive, proactive and good to read. Staying in work is quite often not properly considered as an option for someone with a hronic illness andi shoudl be – with the right advice and support, a working life can be maintained and a work-life balance supported. Work can be very positive and this shouldn’t be overlooked.

This was actually dicussed yesterday at a parliamentary reception I attended that was organised by the Neurological Alliance to highlight the upcoming welfare reforms.  wonderful lady with MS who had worked at the Department of Health for many years after diagnosis spoke and told of how she stayed in work and how positive this was to her for many years.

I wish Rosalind’s book had been around and I had known about it years ago. I would have found it extremely helpful.

I interviewed Rosalind this summer and here are a couple of her answers. To see the full interview, go to the FibroAction website Patients Section.

……………………

Lindsey: What does an executive career coach actually do? I think it is a role more common in the US, but it sounds like something I could have used in the past!

Rosalind: There are several parts to that answer. First as a career coach, my role is to help a person develop the competencies he or she needs to be more successful on the job. Sometimes that means in their current job. Sometimes it means finding a new job or even a new career. As a career coach for people who live with chronic illness, it inevitably includes a clear assessment regarding how the illness impacts their ability to do that job so a person can make the best decisions looking ahead. It often includes working on how you talk about symptoms, accommodations and the other issues that come up when you live with unpredictable and debilitating health. We also work on how to use your networks to get a new job, how to assess an organizational or job fit and so on – all with chronic illness as the backdrop to these decisions. I’ve developed a home study program that’s a compendium to my book and it’s called ‘The Working with Chronic illness Workbook’ – it’s on my website, cicoach.com. It includes many of these assessments. But I do want to clarify that although I was an executive coach at one time, I don’t classify myself as an executive career coach because I work with anyone who cares about work as a career. That’s why my tagline is: The resource for professionals who live with chronic illness.

Lindsey: Many people with chronic illness really struggle at work: I know I have done and I’m sure many readers are thinking that work is not good for their health and maybe they shouldn’t be working. You obviously feel very strongly that women with chronic illness should be able to keep working – and should keep working. It’s something that you discuss from a number of different angles in ‘Women, Work and AutoImmune Disease: Keep Working Girlfriend’, but can you summarise why you think this is so important?

Rosalind: Well, to begin with, as we say in the book, when you stop working, you become financially vulnerable, unless you’re independently wealthy. Even if you have a spouse or parents to support you, you’re relyling on others and that leaves many people feeling vulnerable and hurts their self esteem. And illness leaves you feeling vulnerable enough – and lowers your self esteem. Unemployment usually compounds those negative feelings. Then, there is the social and emotional feedback we get from working that you lose when you’re unemployed. Most of us have had jobs in which we felt we’d rather be anywhere than here, but it’s easy to forget how long a day can be when you’re unemployed. Especially if you’re under 60 and most of the people around you are at work. Also, no doubt, work can be a burden but it can also be a distraction.

That said, I had two children and was so sick with ulcerative colitis that I couldn’t work for two years and could barely get out of bed to get them to school. So I know that there are times when you just can’t work. And there are jobs that are so ‘toxic’ that they are bad for you. Finally there are some people who don’t easily fit into the “working world” and perhaps they wouldn’t have been happy being employed (or self employed) regardless of their health. The book was written for people who want to keep working – to encourage them because there are many factors that make it so difficult, particularly for women.

……………………

To buy ‘Women, Work and AutoImmune Disease: Keep Working Girlfriend’ and help FibroAction whilst doing so, buy the book through FibroAction’s a-store here.

 

Patient UK updates their Fibromyalgia Syndrome information

An announcement made today on the FibroAction website:

FibroAction is pleased to announce that, following our input, Patient UK has updated their online information on Fibromyalgia Syndrome (Fibro).

This is great news! Patient UK is well respected and well used too, both by patients and also by GPs. The information they provide on Fibro is now far more up-to-date and accurate.

Positive changes in the information include:

• The causes of Fibro discussed better reflect research, as they now discuss substance P levels, changes in the brain and central sensitisation.
• It is noted that the name “Fibromyalgia” does not accurately describe the condition.
• The prevalence of Fibro is now more accurate at 1 in 50 or 2%.
• There is not even a hint that Fibro is caused by depression or anxiety.
• The information on the tender points is far more accurate – it is even noted that hypersensitivity to pain can be all over.
• It is noted that quality of life can be affected by Fibro.
• The treatment section is now based on the EULAR evidence based recommendations for the treatment of Fibro.

There are of course still some minor niggles, but the information is so much better than it was that I really think this is a step forward. This update means that it is even more unlikely that, when a GP goes to look up information on Fibro to give to their patients, they will find inaccurate or out-of-date information. FibroAction aims to make up-to-date and accurate information about Fibro easily accessible for both patients and doctors and encouraging the updating of other online information sources is a key part of this. I’m glad that Patient UK were happy to work with us to review and update their information.

 

US Expert to give UK Christmas Lecture

The Christmas lecture by American Fibro expert Andrew Holman MD will now be held at Guy’s Hospital, London instead of St. Thomas’ Hospital, London. This alteration has been made at the request of the Fibromyalgia Syndrome clinic at Guy’s Hospital. Guy’s Hospital and St. Thomas’ Hospital are part of the same NHS Trust and are located near each other in south-east London.

US rheumatologist and Fibromyalgia Syndrome expert Andrew J. Holman MD will be giving a lecture on Fibromyalgia Syndrome on Monday 22nd December, as part of a short visit to the UK. The lecture will be hosted by Prof John E. Davies, who leads the Fibromyalgia Syndrome clinic at Guy’s Hospital, and it is being organised by FibroAction in conjunction with Prof Davies.

This Christmas lecture presents a rare opportunity to hear and ask questions of an expert who is leading the way into new avenues of knowledge and treatment regarding Fibromyalgia Syndrome.

For more information and to register, see the FibroAction Events page.

 

ENFA Petition Needs Your Support

ENFA (the European Network of Fibromyalgia Associations) and the European Federation of IASP Chapters have joined together to produce a petition calling for a European Union in which the rights of the 14 million people affected by Fibromyalgia Syndrome are recognized.

ENFA is hoping to reach their goal of 10,000 signatures by Friday 14th November 2008. If they reach this goal, the petition will be able to be used as leverage to get the remaining signatures needed on the European Parliament Written Declaration about Fibromyalgia Syndrome.

If you haven’t yet put your name to the petition, please do so on the ENFA website here.

 

European Medicines Agency rejects Cymbalta Approval

FibroAction Press release 27 October 2008

 

Severe blow for millions of Fibromyalgia Syndrome 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.

 

For more information see www.fibroaction.org

 

ENDS

 

European Medicines Agency adopts negative opinion on Cymbalta for Fibro

A press release from Eli Lilly and Company – a full response from FibroAction will be coming soon.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has adopted a negative opinion on a Cymbalta® (duloxetine hydrochloride) application for the treatment of fibromyalgia.

“Eli Lilly and Company and Boehringer Ingelheim are naturally disappointed by the CHMP’s opinion,” said James Russell, M.D., global medical director for duloxetine, Eli Lilly and Company. “We remain confident in the duloxetine data.”

No medication has been approved in Europe for the treatment of fibromyalgia, a disease characterized by chronic widespread pain.

The CHMP received data on the use of duloxetine in the treatment of fibromyalgia in 1,411 patients in four placebo-controlled studies and 350 patients in one open-label safety study, a total of 1,761 patients in five clinical trials.(1,2,3,4,5)

The cause of fibromyalgia remains unknown;(6) however, scientists believe it may be related to some combination of genetic disposition(7) and subsequent changes in pain processing in the brain.(6) The disorder, which has a worldwide prevalence ranging from 0.5 percent to 5.0 percent of the population,(8) has a high impact on quality of life. In addition to chronic widespread musculoskeletal pain, many fibromyalgia patients experience other symptoms such as tenderness, fatigue, sleep disturbance, anxiety and depression.(1,9)

In Europe, duloxetine has been approved for the treatment of diabetic peripheral neuropathic pain (DPNP), major depressive episodes, generalised anxiety disorder (GAD) and stress urinary incontinence (SUI). Duloxetine was approved in the United States for the management of fibromyalgia in June 2008 by the U.S. Food and Drug Administration (FDA).

About Eli Lilly and Company

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers — through medicines and information — for some of the world’s most urgent medical needs. For more information please visit www.lilly.co.uk.

About Boehringer Ingelheim

The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 135 affiliates in 47 countries and almost 38,900 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine. In 2007, Boehringer Ingelheim posted net sales of 10.9 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development. For more information please visit www.boehringer-ingelheim.com.

Duloxetine for major depressive episodes, diabetic peripheral neuropathic pain and generalised anxiety disorder is marketed by Lilly and Boehringer Ingelheim in all countries included in the partnership under the brand name Cymbalta, except for Germany, Greece, Italy and Spain. In Germany, Lilly and Boehringer Ingelheim market duloxetine for major depressive episodes under the brand name Cymbalta, and market the product for diabetic peripheral neuropathic pain as Ariclaim®. In Greece, Italy and Spain Lilly markets the product as Cymbalta and Boehringer Ingelheim markets the product as Xeristar®. In the United States, Cymbalta is marketed by Lilly and Quintiles. In Japan, duloxetine is co-developed and co-marketed by Lilly and Shionogi & Co., Ltd.

Duloxetine for stress urinary incontinence is marketed by Lilly under the brand name Yentreve®.

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.
4. Chappell, AS, et al. Duloxetine 60-120 mg Versus Placebo in the Treatment of Fibromyalgia Syndrome. Poster presented at the American College of Rheumatology Annual Meeting; Nov 2007, Boston, MA.
5. Chappell, AS, et al. A 1-Year Safety and Efficacy Study of Duloxetine in Patients with Fibromyalgia. Poster presented at European League Against Rheumatism Annual Meeting; Jun 2008, Paris, France.
6. Leventhal, LJ. Management of Fibromyalgia. Annals of Internal Medicine. 1999; 131: 850-858.
7. Arnold, L, et al. Family Study of Fibromyalgia. Arthritis & Rheumatism. 2004; 50(3): 944-952.
8. White, et al. Classification, Epidemiology, and Natural History of Fibromyalgia. Current Pain and Headache Reports 2001; 5:3320-329
9. Epstein, SA, et al. Psychiatric Disorders in Patients with Fibromyalgia. Psychosomatics. 1999; 40(1):59
10. Rao, SG, et al. Understanding the Fibromyalgia Syndrome. Psychopharmacology Bulletin. 2007: 4:24-67
11. Carville, SF, et al. EULAR Evidence-based Recommendations for the Management of Fibromyalgia Syndrome. Ann Rheum Dis. Republished 2008: 67: 536-541.

Source: Eli Lilly and Company

 

US Fibro Expert to give UK Lecture

US rheumatologist and Fibromyalgia Syndrome expert Andrew J. Holman MD will be giving a lecture on Fibromyalgia Syndrome on Monday 22nd December, as part of a short visit to the UK. The lecture will be hosted by Prof John E. Davies, who leads the Fibromyalgia Syndrome clinic at Guy’s Hospital.

This Christmas lecture presents a rare opportunity to hear and ask questions of an expert who is leading the way into new avenues of knowledge and treatment regarding Fibromyalgia Syndrome. As FibroAction’s first major event, and an accredited educational event for healthcare professionals about Fibro, this is extremely exciting.

For more information, see the announcement about the lecture on the FibroAction website here or get the details and the registration form here.

 

Guest blogging for Invisible Illnesses Week

My guest blogger post is up over at Invisible Illness Week. I chose the topic of ‘Do You Think of Yourself as Sick?’ discussing whether, with a chronic illness, you think of yourself as sick, disabled, or just someone who happens to have health issues. I used the example of my different attitude through years of dealing with migraine, hypermobility syndrome, Irritable Bowel Syndrome and Fibromyalgia Syndrome.

Check it out and maybe consider blogging yourself about Invisible Illness Week 2008 Sept 8-14.