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Fibromyalgia, also known as FM, non-articular rheumatism, soft tissue rheumatism and fibrositis, is a chronic pain illness characterized by widespread musculoskeletal aches and stiffness,

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

soft tissue tenderness, general fatigue, and sleep disturbances.

Although fibromyalgia is a recent medical finding, it is a relatively common disease among Americans affecting over three

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

Examples of combination products may in

ercent of all people. Findings discover that this disease is more likely to develop in women rather than men. The risk of having fibromyalgia also increases with age.

Common Symptoms of F

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

ibromyalgia

Although there are no two people who would experience the same symptoms, making fibromyalgia a more difficult illness to understand. Sufferers generally do experience similar

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

ymptoms.

Pain is one of the major and distinguishing symptoms of this illness and it would usually involve the tender point on the body particularly in the neck, spine, shoulders and hips

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

Combination pro

. Pain usually starts to develop in one area such as the neck or lower back first before spreading to other parts of the body. These localized pain, known as trigger points can cause terri

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

le and immense pain when pressure is applied on them. Sufferers also experience widespread aches and pain, numbness, tingling and burning sensation. The degree of the pain is also often wo

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

rse off in the morning and during cold and humid weather changes.

The other main characteristic of fibromyalgia is chronic fatigue, possibly related to disturbed sleep patterns. Fatigue a

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

d sleep disturbances is affecting about 90% of fibromyalgia sufferers. It is believe that the fatigue involve with fibromyalgia is much more than that of being tired only. It is common for

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

sufferer to wake up as tired as when they went to sleep. Fatigue will also remain for the rest of the day and is understood to be very exhausting both physically and mentally. Sufferers w

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

ll not have the ability to even continue with his simple daily activities.

Some lesser common symptoms reported include irritable bowel syndrome, mild to moderate depression, migraine hea

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

Following aspects would a

daches, abdominal pain, bloating, constipation and diarrhea.

The Diagnostic Process

At present time, the diagnostic process can take years because fibromyalgia remains a condition that c

dd to the challenges in developing combination products:

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

ntinues to baffle doctors. It is label as a often misunderstood disease since the symptoms associated with the illness are so commonly seen in many other diseases and that there is also no

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

clear cut laboratory tests such as biopsy tissue samples, blood tests or x-ray results to give doctors any clue or whatsoever. It also does not help in the diagnosing process when people

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

ith fibromyalgia can also look healthy and show no clear signs of pain or fatigue at all.

The only diagnostic method is through the identification of symptoms shown namely the presence of

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

pain and aches on tender points, and fatigue. Laboratory tests can also be conducted to rule out other illnesses that share similar symptoms with fibromyalgia. Thyroid, Rheumatoid arthrit

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

Professional from academic institutions, pharmaceutical industries, health care indust

s, Lupus, Lyme disease and Polymyalgia rheumatica are some conditions that can be rule out.

Medical science is still a far cry from identifying a cause for fibromyalgia. It is a fact that

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

this disease exist and unfortunately, there are still no known cures for it. It is advisable for people who suspect that they have fibromyalgia to consult a doctor with experience in this

.

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

syndrome. A rheumatologist is the most often the best choice to consult.

Today, patients have only few choices to manage their condition and can only lessen the symptoms associated with i

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

Companies that provide selfless information through particip

t. Fibromyalgia still remains as an idiopathic condition without a known cause or proven proper treatment to fully cure the disease. Hopefully, we can see a breakthrough in the near future

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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