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BFS – also known as 'muscle fasciculation syndrome', 'benign fasciculation' and 'fasciculation syndrome' – is a disorder of the nervous system characterized by the uncontrolled

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

twitching (fasciculation) of muscle groups in various parts of the body. It may or may not be associated with muscle cramps. Although it occurs more commonly in the muscles of t

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

Examples of combination products may in

e legs, arms and face, it can occur in any voluntary muscles, including those of the tongue. As its name suggests, it is a benign, somewhat irksome condition that, fortunately,

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

oes not progress to a more serious neurological disorder.

The fasciculation may be localized – a twitching eyelid for instance – or become far more extensive and involve severa

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

limbs or even the abdominal muscles. They may be either intermittent or continuous; in fact most people will experience a degree of BFS at sometime in their lives without reali

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

Combination pro

ing that they have this condition. For example, a simple facial 'tic' is a localized fasciculation.

However, most individuals will only be aware of the diagnosis of BFS when th

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

symptoms become so widespread and persistent that they seek medical advice.

A more serious disease called amyotrophic lateral sclerosis (ALS) - also known as Lou Gehrig's dise

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

se also has muscle fasciculation as a dominant symptom. Although fasciculation is a feature of both BFS and ALS that of the former usually ceases when the affected muscle is exe

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

cised while the twitching in ALS patients persists whether the muscles are working or at rest. A diagnosis of BFS is usually made after a full neurological examination (includin

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

electromyography – EMG) has excluded other, more serious diseases.

Although the precise cause of BFS is unknown it may be associated with several factors including acute viral

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

illnesses, exercise, anxiety or drugs. Some authorities have suggested that insecticides could also be a causative factor as muscle fasciculation is one of the prominent symptom

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

Following aspects would a

s seen in organophosphate poisoning.

Exercise triggers muscle twitching in the majority of BFS patients that and is probably related to the higher than normal amounts of free r

dd to the challenges in developing combination products:

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

dicals that are released by the body during prolonged exertion.

Free radicals are a by-product of the cell's energy production therefore the longer and more intensely an indivi

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

ual exercises the more free radicals his body will produce. For this reason endurance athletes are subject to free radical overload and oxidative stress. If prolonged exercise i

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

associated with BFS, in all likelihood the cause of the twitching is free radical-induced nerve and muscle excitability.

Although there are no recognized drugs for the treatme

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

t of BFS, anecdotal reports suggest that some individuals benefit from either pharmaceutical or natural sedatives. However no clinical trials have been done to show whether or n

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

Professional from academic institutions, pharmaceutical industries, health care indust

t these products are more effective than placebos.

As prolonged physical activity produces large quantities of free radicals and exercise is such a strong precipitating factor

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

or BFS, oxidative stress is almost certainly one of the underlying pathological factors contributing to this condition.

Therefore it is not surprising to find that there is rel

.

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

able anecdotal evidence that antioxidant-rich food supplements are effective in treating this annoying, and often distressing, condition.

It is also possible that even those in

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

Companies that provide selfless information through particip

ividuals who do not suffer from exercise induced BFS may be under oxidative stress for other reasons and could reduce their symptoms by increasing their daily antioxidant intake

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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