Fibromyalgia Centers of America Announces Treatment Center in Illinois

From the News Desk of Jeanne Hambleton 

 

The Nationwide Group of Doctors of Fibromyalgia Centers of America has opened a fibromyalgia treatment center for the Joliet / Crest Hill region.

Fibromyalgia Centers of America is a nationwide group of doctors dedicated to researching and sharing with other doctors effective treatments and techniques for treating fibromyalgia.

Each treatment is specialized according to the individual, and through collaboration with doctors across the nation, treatments are not only personalized but offer technological breakthroughs not previously available.

Fibromyalgia Centers of America (fibromyalgiacentersamerica.com) is dedicated to helping people who suffer with fibromyalgia syndrome and also helping those that have the same symptoms, but have not been diagnosed.

Treatment begins when you are ready to find out the cause of your problem. A board-certified and licensed doctor will personally sit down and consult with you.

General signs and symptoms of Fibromyalgia include: tempo mandibular joint dysfunction, skeletal pain and whole body aches, fatigue, trouble sleeping, depression, chronic headaches, bowel disturbances, anxiety, racing heatbeats, and decreased coordination.

Trigger points are areas of tenderness in a muscle, and trigger points may be associated with myofascial pain syndromes or Fibromyalgia.

With over 100 clinics nationwide, the Crest Hill location is the first to come to the Metro Chicago area.

 

Editor’s Note

What great news for those suffering with this invisible disability in the USA and good luck. But when will we have  a similar nationwide organisation in the UK. We are, after all, light years behind the States and Canada. We are waiting for  someone to get started with a string of  FMS  UK centres – http://www.fibromyalgiacentresbritain.co.uk maybe ???.

We are grateful to Professor John Davies and  his team for their stirling work in the fibromyalgia field  at Guy’s and both his FM Clinics,  and the small pockets of professionals and researcher beavering away, but we need more recognised help nationwide – much more including a substantial grant  from our Government to fund  fibromyalgia research. Even a national register of where FMS help is available would help those suffering with FMS.

These centres could be used for a rota of complementary therapies, physiotherapy,  to care for our teeth, feet etc. and small groups of researchers. This would help cover the cost of providing a fibromyalgia clinic.  Drug companies such as Pfizer and Lilly who have shown an interest in FMS medication should be encouraged to sponsor these centres. It is possible in today’s climate of  doom, gloom and stress that these companies and this industry are among the few not feeling the pinch with the credit crunch – people will always be ill and take medication. 

I hope those in the corridors of power are listening.  Will someone please tell them, not that I think Gordon Brown would be interested at the moment, but David Cameron just might!  Keep well Jeanne  Hambleton

FDA APPROVES NEW FIBROMYALGIA DRUG

From the FMS Global News Jeanne Hambleton 

Forest and Cypress Announce FDA Approval of Savella(TM) for the Management of Fibromyalgia

Posted January 14, 2009

New treatment option for the estimated 6 million Americans living with this chronic, debilitating condition

NEW YORK and SAN DIEGO, Jan. 14, 2009 /PRNewswire-FirstCall/ — Forest Laboratories, Inc. (NYSE: FRX) and Cypress Bioscience, Inc. (Nasdaq: CYPB) today announced that Savella(TM) (milnacipran HCl), a selective serotonin and norepinephrine dual reuptake inhibitor, was approved by the U.S. Food and Drug Administration (FDA) for the management of fibromyalgia. Fibromyalgia is a chronic condition characterized by widespread pain and decreased physical function, afflicting as many as six million people in the United States. The safety and efficacy of Savella was established in two US pivotal phase III clinical trials involving over 2,000 patients with fibromyalgia. The studies showed that Savella doses of 100 mg/day and 200 mg/day demonstrated statistically significant and clinically meaningful concurrent improvements in pain, patient global assessment, and physical function. The companies expect Savella to be available in pharmacies by March 2009.

“Fibromyalgia is a complicated chronic pain condition, so it is important that physicians and patients have access to treatments that have been shown to help manage the symptoms that define the experience of fibromyalgia,” said Dr. Daniel Clauw, Professor of Anesthesiology and Medicine (Rheumatology) at the University of Michigan. “The introduction of Savella is important because it is the first drug approved to treat the symptoms of fibromyalgia using a composite responder analysis.”.

“Savella is the product of a unique clinical development program, one that considered a patient to be a responder to therapy only if they demonstrated concurrent clinically significant changes in multiple aspects of their fibromyalgia, including pain, patient global assessment and physical function. Savella is the only product approved for the management of fibromyalgia that used this complete responder analysis as its primary endpoint,” said Jay D. Kranzler, MD, PhD, Chairman and CEO of Cypress Bioscience.

Howard Solomon, Chairman and Chief Executive Officer of Forest said, “We and our partner Cypress Bioscience are very pleased to receive marketing approval for Savella, following a first-cycle review, from the FDA. Fibromyalgia is a chronic and often debilitating condition with a significant need for new therapies. Savella is a valuable new treatment for patients afflicted with fibromyalgia. Its effectiveness was evaluated based upon the multiple symptoms included in the responder analysis.”

“This approval is crucial for Pierre Fabre Laboratories as milnacipran is one of the flagship products of our portfolio and represents another product of Pierre Fabre research registered in the United States,” said Jean-Pierre Garnier, Chief Executive Officer of Pierre Fabre SA.

Although the exact mechanism by which Savella improves the symptoms of fibromyalgia is unknown, some researchers believe that abnormalities in certain brain neurotransmitters may be central to fibromyalgia. Savella blocks the reuptake of both norepinephrine and serotonin, with greater selectivity for the inhibition of norepinephrine reuptake in vitro. This may be the mechanism by which Savella acts to improve the symptoms of fibromyalgia.

Data Highlights

The clinical development program for Savella was unique in its use of a composite responder analysis as the primary endpoint. This endpoint required individual patients to demonstrate concurrent improvement to multiple validated measures, including pain (visual analog scale), patient global assessment (patient global impression of change), and physical function (Short Form-36 Physical Component Summary).

The efficacy of Savella was established in two US pivotal Phase III clinical trials involving 2,084 treated patients (1,460 Savella; 624 placebo), which showed that Savella demonstrated clinically significant improvements compared to placebo in treating fibromyalgia. The first study was 6 months in duration and the second study was 3 months in duration.

In both studies, a greater proportion of patients in the Savella treatment arms (100 mg/day and 200 mg/day) as compared with placebo treatment, at 3 months, experienced at least a 30% reduction in pain from baseline and also rated themselves as “very much improved” or “much improved” based on the patient global assessment. In addition, a greater proportion of patients treated with Savella as compared with placebo treatment met the criteria for a treatment response as measured by concurrent improvements in pain, physical function, and patient global assessment. In both studies, some patients who rated themselves as globally “much” or “very much” improved experienced a decrease in pain as early as week 1 of treatment with a stable dose of Savella that persisted throughout these studies.

The clinical development program demonstrated that Savella was safe and generally well tolerated. The most frequently occurring adverse reaction was nausea. Other common adverse reactions reported in these clinical trials were constipation, hot flush, hyperhidrosis, vomiting, palpitations, heart rate increased, dry mouth and hypertension. The majority of adverse reactions reported were mild to moderate in nature.

About Savella

Savella is a dual-reuptake inhibitor that preferentially blocks the reuptake of norepinephrine with higher potency than serotonin (in-vitro), two neurotransmitters thought to a play a central role in the symptoms of fibromyalgia. Savella will be marketed by Forest and its licensor, Cypress Bioscience. Pierre Fabre, who originally developed and sells milnacipran outside the U.S., licensed the rights for North America to Cypress Bioscience.

About Fibromyalgia

Fibromyalgia is a chronic and debilitating condition characterized by widespread pain and decreased physical functioning. According to the American College of Rheumatology fibromyalgia is estimated to affect over 6 million Americans. It is most often diagnosed in the primary care setting and is the second most commonly diagnosed condition in rheumatology clinics in the United States after osteoarthritis. Despite the high prevalence and severity of this condition, there are limited treatment options specifically approved for fibromyalgia in the United States.

Important Safety Information

Savella is a selective serotonin and norepinephrine inhibitor (SNRI), similar to some drugs used for the treatment of depression and other psychiatric disorders. Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of such drugs in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on Savella should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Savella is not approved for use in the treatment of major depressive disorder. Savella is not approved for use in pediatric patients.

Savella is contraindicated in patients taking monoamine oxidase inhibitors (MAOIs) concomitantly or within 14 days of discontinuing treatment of an MAOI or in patients with uncontrolled narrow-angle glaucoma.

Development of a potentially life-threatening serotonin syndrome may occur with agents that inhibit serotonin reuptake, including Savella, particularly with concomitant use of serotonergic drugs (including triptans and tramadol) and with drugs which impair metabolism of serotonin (including MAOIs). The concomitant use of Savella with serotonin precursors is not recommended.

Blood pressure and heart rate should be monitored prior to initiating treatment with Savella and periodically throughout treatment. SNRIs, including Savella, have been associated with reports of increases in blood pressure and heart rate. Pre-existing hypertension, tachyarrhythmias and other cardiac diseases should be treated before starting therapy with Savella. Savella should be used with caution in patients with significant hypertension or cardiac disease. For patients who experience a sustained increase in blood pressure or heart rate while receiving Savella, either dose reduction or discontinuation should be considered.

Savella should be prescribed with caution in patients with a history of a seizure disorder, mania or controlled narrow-angle glaucoma.

Savella has been associated with mild elevations of ALT and AST. Rarely, fulminant hepatitis has been reported in patients treated with milnacipran. Savella should be discontinued in patients who develop jaundice or other evidence of liver dysfunction and should not be resumed unless another cause can be established.

Savella should ordinarily not be prescribed to patients with substantial alcohol use or evidence of chronic liver disease.

As with other SNRIs and SSRIs withdrawal symptoms have been observed following discontinuation of milnacipran. A gradual dose reduction is recommended.

Hyponatremia may occur as a result of treatment with SSRIs and SNRIs, including Savella. Discontinuation should be considered for patients with symptomatic hyponatremia.

SSRIs and SNRIs, including Savella, may increase the risk of bleeding events. Patients should be cautioned regarding the risk of bleeding associated with concomitant use of Savella and NSAIDs, aspirin, warfarin or other drugs that affect coagulation.

Male patients with a history of obstructive uropathies may experience higher rates of genitourinary adverse events.

Savella is unlikely to be involved in clinically significant pharmacokinetic drug interactions. Pharmacodynamic interactions of Savella with other drugs can occur.

Savella contains FD&C Yellow No. 5, which may cause allergic-type reactions in susceptible persons.

In clinical trials, the most frequently occurring adverse reaction was nausea. The most commonly occurring adverse reactions (greater than or equal to 5% and twice that of placebo) were constipation, hot flush, hyperhidrosis, vomiting, palpitations, heart rate increased, dry mouth, and hypertension.

About Forest Laboratories

Forest Laboratories (NYSE: FRX) is a U.S.-based pharmaceutical company with a long track record of building partnerships and developing and marketing products that make a positive difference in people’s lives. In addition to its well-established franchises in therapeutic areas of the central nervous and cardiovascular systems, Forest’s current pipeline includes product candidates in all stages of development and across a wide range of therapeutic areas. The company is headquartered in New York, NY. To learn more about Forest Laboratories, visit http://www.FRX.com.

Except for the historical information contained herein, this release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, the acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products, and the risk factors listed from time to time in Forest Laboratories’ Annual Report on Form 10-K, Quarterly Report on Form 10-Q, and any subsequent SEC filings.

About Cypress Bioscience

Cypress Bioscience, Inc. provides therapeutics and personalized medicine services, facilitating improved and individualized patient care. Cypress addresses the evolving needs of specialist physicians and their patients by identifying unmet medical needs in the areas of pain, rheumatology, and physical medicine and rehabilitation, including challenging disorders such as fibromyalgia and rheumatoid arthritis. This approach to improving patient care creates a unique partnership with physicians.

For more information about Cypress, please visit the Company’s website at http://www.cypressbio.com.

This press release, as well as Cypress’ SEC filings and website at http://www.cypressbio.com, contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 including statements about the potential of Savella to treat fibromyalgia syndrome and its availability in pharmacies by March 2009. Actual results could vary materially from those described as a result of a number of factors, including those set forth in Cypress’ Annual Report on Form 10-K, the most recent Quarterly Report on Form 10-Q and any subsequent SEC filings and including, but not limited to, that Savella may not achieve market acceptance.

About Pierre Fabre

The Pierre Fabre group, France’s second biggest independent pharmaceutical laboratory, achieved a turnover of 1.7 billion euros in 2007. It employs nearly 10,000 people including 1,400 in the research sector. Its business sectors are ethical products, healthcare products and dermocosmetics with the brands Avene, Ducray, A Derma, Galenic, Klorane and Rene Furterer. The Pierre Fabre group dedicates 25% of its annual turnover to R&D in five main therapeutic directions: oncology (PFM’s priority R&D sector with 50% of the over all R&D budget), the Central Nervous System, cardiology, internal medicine /urology and dermatology.

To learn more about the Pierre Fabre group, visit http://www.pierre-fabre.com.

SOURCE Forest Laboratories, Inc.; Cypress Bioscience, Inc.

(http://www.fiercebiotech.com/press-releases/forest-and-cypress-announce-fda-approval-savella-tm-management-fibromyalgia)

Dual action

From Jeanne Hambleton’s FMS Global News Desk
By Sandra Flahive (FiftySomething) January 10 2009

Bill and Susan Steffey of Grimes both have seen great physical improvements since they began exercising together at the Wellness Center at Mercy Medical Center.

Susan, 55, first started a regular workout regimen in July on the advice of her rheumatologist. Bill, 60, joined her a couple months later, hoping to lose weight and lower his cholesterol.

Three days a week, the couple attends a low-impact aerobics class that’s especially tailored to older adults. They warm up on the treadmill before class. Afterward, Bill hits the weights while Susan gets on the elliptical machine.

Both have lost weight since they began exercising regularly. Susan, who has arthritis, fibromyalgia and a pulmonary disease, says her muscles and joints are stronger and her lung capacity has improved.

Through weight training, Bill says he has been able to strengthen his bad knee and can now get up stairs without using the handrail to pull himself up.

“Neither one of us will go without the other one,” Susan says of their workouts. “That’s a huge motivator because you feel guilty. And we’ve made great friends.”

It has also given them a chance to spend more together and become closer, she says.

Because his wife’s health and stamina have improved, they are considering taking vacations, Bill says. That includes travelling to Indianapolis for a NASCAR race in July.

“Now that she is working (out) … she has got a little stronger, and we are talking about doing those things again together,” he says.

What a difference a year makes. A year is about how long Ankeny couple Bill Riley Jr. and his wife, Bridget, have been regulars at the Aspen Active Fitness Center in the West Glen Town Center.

With the help of their respective personal trainers, the Rileys say their lives have changed dramatically. The two – who were not regular exercisers – now give each other workout tips, regularly check on one another’s progress and have bought fitness equipment to use at home.

They say they feel better, have replaced body fat with muscle, eat more healthfully and are excited about the future.

“We are enjoying this. We are feeling that we are doing something for ourselves and not just letting ‘old man time’ chip away at us,” says Bill, 51. “We are feeling a lot better about being 60, 65, 70. We plan on being very active … and you cannot do that without your health. We made the decision to start that now, and we are glad we did it.”

In the past, fitness clubs had been intimidating and uncomfortable places for him and his wife, Bill says. Then he met certified personal trainer Mickey Pesek at Aspen Athletic Fitness Center.

“The personal training has made a huge difference in our outlook and opinions of joining a gym,” says Bill, whose triglycerides, cholesterol and blood pressure have decreased.

Bridget, an oncology nurse, says several factors influenced her to join her husband in getting fit: turning 50, her mother having a massive stroke a year ago and seeing how good her husband was feeling.

Bridget works with certified personal trainer Trista Manikowske. “She makes me feel confident and accomplished,” she says. “It is probably the best I have felt health-wise since I was 20.”

She says she feels healthier, has a better attitude about herself and sleeps better. The couple rarely eats out anymore, she says, and have added more fish and protein to their diet.

“We talk about growing old together and walking together and being outdoors. We talk about doing vacations that involve a lot of walking … and keeping our hearts healthy and blood pressure good,” Bridget says.

Setting goals together helps the two individuals be supportive of, and accountable to, each other, says Manikowske, the personal trainer. It is also a good idea to write down those goals.

“People with written goals accomplish five to 10 times as much as people who have never taken the time to actually write them down. It helps you remember what they are,” she says.

7 Tips for Exercising in Tandem
Certified trainers Trista Manikowske and Mickey Pesek offer these suggestions for couples working together toward physical fitness.

• Make a plan together and stick to it. Devise a workout schedule and, if you are working out separately, ask each other questions about your progress.

• Decide on a reward for meeting your goals. Looking forward to a vacation, for example, can motivate and encourage you.

• Find fun physical activities you can do together.

• Plan healthful meals, shop for groceries and cook as a couple.

• When going out to eat, split portions with each other.

• Get the whole family involved in eating more healthfully and exercising.

• For a spouse or significant other reluctant to get more physically active, give a gym membership as a birthday or anniversary gift or invite the person to work out with you. Some personal trainers offer “buddy sessions,” where two people get personal training together for an hour.

Good advice….My thanks to the Desmoine Register http://www.desmoinesregister.com/article/20090110/FIFTYSOMETHING/301110005/-1/SPORTS12

European Network of Fibromyalgia Associations

From the desk of Jeanne Hambleton

Members of the European Parliament (MEPs) adopt written declaration 69/2008 on fibromyalgia initiated by five deputies and the European Network of Fibromyalgia Associations (ENFA).

Brussels (16.12.2008) – Written Declaration 69/2008 on fibromyalgia has been a success in the European Parliament by finding the necessary quorum of signatories of 393 deputies giving their support. The Written Declaration was initiated by five key MEPs active on health at the European Parliament: Mr. Adamou, Ms. Brepoels, Ms. Dičkuté, Mr. Popa and Ms. Sinnott. These MEPs decided to launch the declaration during the celebratory meeting of the 1st European Fibromyalgia Awareness Day in May 2008, organized by ENFA

The Written Declaration is calling on the European Union to recognize fibromyalgia in Europe as a disease, as WHO did in 1992. It is estimated that 14 million people in Europe suffer from fibromyalgia and the condition is more prevalent with women (87% of total prevalence).

Fibromyalgia is a complex disease with a variety of symptoms in addition to the defining symptom – chronic widespread pain. These include 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. Some scientists believe that there is an abnormality in how the body responds to pain, and particularly a heightened sensitivity to stimuli.

Fibromyalgia imposes large economic burdens on society as well as on affected individuals. A study shows that an average patient in Europe consults up to 7 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. Research in the UK has shown that diagnosis and positive management of Fibromyalgia reduce healthcare cost by avoiding unnecessary investigations and consultations

Thus, the European Parliament is calling through this declaration, for the European Commission and the Council, to help raise awareness of the condition and facilitate access to information for health professionals and patients, by supporting European and national awareness campaigns; to encourage Member States to improve access to diagnosis and treatment; to facilitate research on fibromyalgia through the work programmes of the EU 7th Framework Programme for Research and future research programmes; and finally to facilitate the development of programmes for collecting data on fibromyalgia.

Educating healthcare professionals, patients and the public to promote better understanding and management of Fibromyalgia will benefit patients, healthcare providers and the society.
A Written Declaration is a text of up to 200 words on a matter falling within the European Union’s sphere of activities. MEPs can use them in order to launch or relaunch a debate on a subject that comes within the EU’s remit. At the end of the lapsing date (3 months after its launch on 1 September for the declaration 69/2008) the declaration is forwarded to the institutions named in the text, together with the names of the signatories.

Contact:
European Network of Fibromyalgia Associations (ENFA)
Mr. Robert Boelhouwer
President of ENFA
contact@enfa-europe.eu
www.enfa-europe.eu

About ENFA
ENFA is a network of patient association and support groups working in close consultation with the national association in the relevant country. Our joint missions are to conquer the myths and misunderstandings around Fibromyalgia. The network will help collectively push forward the boundaries which currently exist in understanding, experiencing and treatment of Fibromyalgia. Our main goal is to see fibromyalgia receiving the recognition it deserves across Europe as an illness in its own right.