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Carpal tunnel syndrome is a nerve entrapment disorder that is associated with considerable pain and functional impairment of the fingers and hand. It is also quite common for this condition

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

to refer pain up the median nerve pathway into the elbow, shoulder, upper back and neck.

Caused by an imbalance of the muscles that open, close, deviate and rotate the hand, results in bi

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

Examples of combination products may in

omechanical dysfunction and a joint imbalance, affecting the median nerve at the wrist junction. Severe cases of carpal tunnel syndrome can lead to muscle atrophy and deterioration of the

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

median nerve when left untreated. It is the cause of significant disability worldwide and a subject of growing research in the medical and physical therapy communities. With costs to treat

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

this disorder surpassing 60 billion annually, a common sense treatment approach is being sought by both private and federal communities.

There are many pathways to muscle imbalance in the

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

Combination pro

hand, and considerable research has examined the pressure system surrounding the carpal canal. This work has shown that people with carpal tunnel syndrome have markedly increased pressure i

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

n the carpal canal in the hand following minor movement in the wrist that involve repetitive and/or static wrist and finger flexion. The longer these types of activities are performed, the

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

greater the muscle imbalance develops and the more severe the symptoms become. As the finger and wrist flexor muscles that close the hand become more developed than their opposing extenso

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

muscles that open the hand, the stronger muscles cause the bones to shift in the direction due to the “pulling” action of the stronger muscles and results in the impingement of the structu

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

res between. In this case, the median nerve is impinged. As the median nerve and flexor tendons now have to glide past each other as the fingers and wrist flex and extend while being in a

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

state of impingement, there is increased friction which irritates the tendons and nerve and causes inflammation and swelling of these tissues. The result of this pressure and secondary swe

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

Following aspects would a

lling is a further increase in edema inside the median nerve. (Swelling is often thought of as the “cause” of carpal tunnel, when in fact it is the “result” of being irritated due to its s

dd to the challenges in developing combination products:

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

ate of being impinged between the flexor tendons inside the carpal tunnel which has also been reduced in size due to the collapse / shifting of the carpal bones.)

This entrapment produces

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

a variety of painful symptoms. Indeed, carpal tunnel syndrome is characterized by paresthesia (also known as a pins and needles), numbness, tingling and a lack of coordination of the finger

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

s along with muscle degeneration if left untreated, but it may also include pain, stiffness, tenderness, and swelling, and many people with the condition notice themselves assuming a ginger

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

stance at the computer keyboard or workstation. As symptoms progress and worsen over time, carpal tunnel syndrome generally includes muscle wasting, diminished strength, and a serious loss

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

Professional from academic institutions, pharmaceutical industries, health care indust

of overall dexterity and coordination.

Although the disorder is significantly debilitating, effective treatments do exist. Those with the most scientific support target symptoms by restori

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

ng muscle balance in the hand. Most often a combination of strengthening and lengthening exercises combined with supportive equipment is enough to improve symptoms dramatically.

By address

.

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

ing carpal tunnel with conservative modes of treatment (Flextend), people can usually avoid the high failure rates associated with treatments like cortisone injections and surgery. Always

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

Companies that provide selfless information through particip

be sure to consult with your physician and be sure that you have a received an accurate diagnosis of your condition, but if you do not agree with your doctor, seek a second or third opinion

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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