Advice Pool - Health and Fitness

Diabetic Neuropathy is damage to nerves caused by the prolonged effect of high sugar levels in the blood. High blood sugar is a consequence of having diab

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

etes. Diabetics strive to manage their blood sugar levels by eating a healthy diet, exercising (and injecting insulin in some cases). It is believed that

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

Examples of combination products may in

keeping blood sugar levels low or at least constant is the best way to manage diabetes and prevent further complications occurring. This article will outl

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

ine the various types of neuropathy, why it is important to treat them and how they are treated.

Diabetic neuropathy can affect any nerve or system of ne

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

rves in the body and has be sub-classified by the parts of the body that they affect. The four types are :

Peripheral - that affects the extremities of t

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

Combination pro

he body, notably the feet.

Autonomic - that affects the autonomic nervous system that is responsible for the automatic processes that go on in the body.

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

They manifest in the stomach generally.

Proximal - the areas affects are the hips, thighs and buttocks.

Focal - a focused group of nerves in any region

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

of the body. This is characterized by sudden 'flare ups' of irritation or pain in a specific part of the body. They are as likely to 'flare down' or dissi

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

pate with treatment as they are to 'flare up'.

The most common form of neuropathy is peripheral neuropathy. It generally affects the feet but can move in

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

to the legs. It is also known to affect the hands and arms but is less common. The most obvious signs of peripheral neuropathy are numbness or tingling in

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

the feet. As the nerves become more damaged the loss of feeling in the feet increases. This insensitivity is exacerbated because the feet of diabetics are

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

Following aspects would a

prone to cuts and bruises. Without the sensation of pain that might accompany a cut the cut can be left untreated and fester. This can lead to gangrene a

dd to the challenges in developing combination products:

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

nd infection. In some cases people have had to have feet amputated.

This is why treatment and prevention are important for diabetic neuropathy.

Treatmen

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

t of diabetic neuropathy is problematic because the symptoms can affect any part of the body. Therefore the treatment of neuropathy focuses on dealing wit

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

h the immediate symptoms and then working on preventing the neuropathy from worsening.

The immediate symptoms may be any form of pain or irritation in th

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

e feet, for example. A pain killing medicine might be prescribed, a cream might be administered to the area most affected or a therapeutic course of actio

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

Professional from academic institutions, pharmaceutical industries, health care indust

n like acupuncture, might be followed.

In conjunction with this treatment of the immediate problem, a long term prevention strategy will be advised. Long

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

term prevention means keeping the blood sugar level low or within a target range that is recommended by your doctor. The best way to do this would be to

.

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

devise and stick to a diabetic diet, exercise regularly and take insulin replacement therapy to control the blood sugar levels before or after eating. Thi

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

Companies that provide selfless information through particip

s will require a fair amount of discipline from the diabetic but the complications of diabetic neuropathy will be far worse over time if allowed to worsen

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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