Advice Pool - Health and Fitness

According to the National Institute of Mental Health, depression is the most com

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

mon diagnosis among adults in the United States today. It is estimated that one

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

Examples of combination products may in

ut of three depressed people suffer from some form of addiction or substance abu

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

e problem. In addition to the above, there appears to be a common tendency among

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

those suffering from depression to abuse drugs or alcohol as a means of coping w

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

Combination pro

th their symptoms. Many of these people end up with an addiction to those substa

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

ces.

Dual diagnosis can create a very complex situation for both the profession

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

al, as well as, the individual. One of the obstacles they face is while the pers

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

n may feel depressed, there are many drugs, including alcohol that create sympto

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

s similar in nature to depression. The "million dollar" question is, which came

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

irst, the depressive disorder or the addiction/alcoholism causing it?

Although

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

Following aspects would a

here appears to be a clear link between depression and addiction or drug/alcohol

dd to the challenges in developing combination products:

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

use, it is not clear that one necessarily precedes the other. Many times though,

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

the depressive disorder appears first and the person begins to use drugs or alco

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

hol as a means to better cope with the symptoms. This type of self-medication ge

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

erally leads to addiction or alcoholism with the person in need of drug rehab or

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

Professional from academic institutions, pharmaceutical industries, health care indust

alcoholism treatment. Regardless of which issue develops first, they must be tre

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

ted co-currently in rehab for the person to fully recover.

The most important t

.

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 is to work with a physician who fully understands drug addiction, alcoholism

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

Companies that provide selfless information through particip

and is associated with an accredited addiction treatment center

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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