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Fibromyalgia is a chronic, widespread, debilitating disease that often manifests as diffuse pain, constant muscle aches and overwhelming fatigue. Although it affects about 2-6% of the general population (about five million

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

people), fibromyalgia is not a contagious disease. Women are about 9 times more likely to be diagnosed than men, and it is most prevalent in prevalent in people between 20-50 years of age.

Fibromyalgia usually displays a

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

variety of symptoms including generalized aches and pains, increased sensitivity of the skin, chronic fatigue, weakness or dizziness, muscle stiffness or joint pain and migraine headaches. Symptoms of fibromyalgia vary gr

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

atly between individuals but almost all suffer from an associated sleep disorder. Depression, anxiety, irritable bowel syndrome, numbness and tingling of the extremities and heightened sensitivity to stimuli may also be pr

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

esent.

Currently, there is no known specific cause of fibromyalgia. Popular opinion suggests a disorder in pain perception and processing in the pathways to the brain. Research has shown that fibromyalgia patients have el

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

vated levels of substance P (involved with enhanced pain perception) and a lower than normal production of natural stress hormones. Another theory revolves around a sleep disturbance as the cause, because many fibromyalgia

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

patients cannot attain deep sleep. Still other theories have implicated reduced immune system function, environmental toxins, abnormal hormonal fluctuations, viral causes, genetic links and dysfunctional neurotransmitters

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

Although exciting new research is constantly being done, the cause of fibromyalgia remains elusive and has the medical world stumped.

Diagnosis of fibromyalgia is based on a specific set of criteria, including a physical

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

examination or observation, and the symptoms described by the patient. Ruling out other possible diseases is key. Currently, there are no conclusive laboratory tests to identify fibromyalgia but for diagnostic purposes, t

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

ere has to be a history of diffuse pain lasting longer than three months. Another diagnostic requirement is the presence of at least 11 "tender points" out of a possible 18 and these are typically located at elbow and knee

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

joints, the neck, shoulders, lower back and hips...

Individual cases of fibromyalgia have a wide variability, but many patients also suffer from other disorders as well. These comorbid syndromes commonly include chronic

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

clinical depression, lyme disease, chronic fatigue sydrome, premenstrual syndrome, restless legs syndrome, spinal disorders, or hypothyroidism. There are also many factors that can aggravate fibromyalgia. Severe weather ch

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

nges, nutritional deficiencies, over-exertion, increases in stress levels, allergies and cold weather have all been shown to contribute to flare-ups.

Treatment of fibromyalgia has historically been inadequate at best. The

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

re is no cure for the disease and therapies are usually aimed at alleviating the symptoms and improving quality of sleep. Medications commonly prescribed for fibromyalgia include conventional analgesics, low-dose antidepre

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

sants, muscle relaxants and sleep-inducing agents. Alternative therapies that have shown some promise include acupuncture, chiropractic care, physical therapy, meditation or relaxation techniques and a gentle aerobic exerc

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

ise program. Other important considerations to prevent fibromyalgia from flaring up include a regular sleep routine, emotional and physical stress reduction, good social support networks and strategies to conserve energy a

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

d minimize triggering factors.

Fibromyalgia can be a very difficult disease to live with because of its chronic, disabling nature and the presence of widespread skepticism. There is often no objective evidence of physical

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

illness and the disease is very poorly understood. Sufferers of fibromyalgia face accusations of laziness or feigning illness. Social activity and recreation is often be avoided and the patient's career is usually affecte

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

as well. Although fibromyalgia can affect every aspect of its victims' lives, it does not have to be as devastating as it once was. With advanced scientific research and promising new treatments waiting in the wings, anyt

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

hing's possible.

Disclaimer - The information presented here should not be interpreted as or substituted for medical advice. Please talk to a qualified professional for more information about Fibromyalgia

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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