E-Articles - Health and Fitness

Nobody likes to suffer pain. An unpleasant sensation, pain is a reaction of the body to physical illness, i

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

njury, or mental disease. Pain is generally divided into two categories: acute and chronic. The former occu

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

Examples of combination products may in

rs suddenly because of injury suffered by a tissue. The injury can be inflicted by anything that damages bo

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

y tissue, i.e., surgery, trauma or cancer. Heart rate and blood pressure usually rises in acute pain. But o

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

nce the cause of the pain is eliminated, the pain normally goes away. Chronic pain, usually linked to a chr

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

Combination pro

onic disease, persists longer and lacks a clear cause. Chronic lower-back pain, chronic headaches, or cance

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

pain belongs to this category.

A pain management strategy usually depends on the nature of the pain, i.e.

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

, whether it is acute or chronic. Pain is generally managed by using medical methods, psychological methods

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

or alternative therapy approaches. In the case of short-term acute pain caused by a trauma, standard medic

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

tions available over the counter, herbal or natural remedies and alternative medicines can be used. Chronic

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

pain is harder to tackle, as it lasts longer and is more complex.

Medical approaches can be divided into

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

Following aspects would a

two main methods: drug treatment and surgical intervention. Analgesic drugs can reduce or eliminate pain wi

dd to the challenges in developing combination products:

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

hout affecting consciousness. Psychotropic drugs act on the brain, influencing the patient's emotional stat

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

e. One should, however, be careful about their long-term effects. Another method used is nerve blocking, in

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

which a drug is injected around the appropriate nerve to prevent the pain message from reaching the brain.

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

The rationale behind the surgical division of nerve pathways is that if the pathway is broken, the pain me

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

Professional from academic institutions, pharmaceutical industries, health care indust

ssage cannot get through. Although not surgical in the true sense, Transcutaneous Electrical Nerve Stimulat

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

ion (TENS) stimulates the skin area over the site of the pain with the help of an electric stimulator, and

.

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

eplaces the pain messages with a tingling sensation.

Although useful in some cases of acute pain, acupunct

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

Companies that provide selfless information through particip

ure may not prove very effective in chronic pain. Some advocate the use of hypnosis to reduce pain, as well

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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