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Depression is often called “mental illness” and most of us know about the emotional symptoms of depression. However, clinical depression fre

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

quently causes physical symptoms as well. In fact, a lot of people with depression feel pain or other physical indications, which include:

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

Examples of combination products may in

Headaches. These are somewhat widespread physical symptoms of depression in people. If one already suffers from migraine headaches, these b

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

come worse when they are depressed.

Muscle aches and joint pain. This is one of the physical symptoms of depression which is aggravated wit

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

h depression; chronic pains become worse with depression.

Back pain. People suffering from back pain gets it more often when they are depre

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

Combination pro

sed.

Chest pain. Apparently, it is very essential that one experiencing chest pain should be checked by a specialist immediately because it

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

can be a sign of a serious heart problem. However, chest pain is also one of the physical symptoms of depression.

Sleeping problems. Sever

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 people suffering from depression can no longer sleep well; they either wake up too early or have trouble sleeping when they go to bed. O

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

hers have excessive sleeping.

Digestive problems. One of the common physical symptoms of depression are feeling queasy or nauseous, includi

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

g having diarrhea or becoming chronically constipated.

Exhaustion and fatigue. The feeling of being tired or worn out no matter how much sl

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

ep one does is one of the physical symptoms of depression. Even getting out of bed may seem very difficult if not impossible to do.

Change

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

Following aspects would a

in appetite or weight. Weight and appetite are also affected with depression. Some people lose appetite and weight, but for some they find

dd to the challenges in developing combination products:

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

cravings for certain foods like chocolates and carbohydrates, therefore they gain more weight.

Dizziness or lightheadedness. Depressed peop

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

e may experience being lightheaded or dizzy when they wake up in the morning or during the day.

A lot of people who have depression never g

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

et help because they are not aware that their physical symptoms may be caused by depression, and a lot of doctors miss the symptoms as well.

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 physical symptoms of depression are not “all in your head”, it can cause real changes in the body that can result to a lot of physical

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

Professional from academic institutions, pharmaceutical industries, health care indust

roblems.

Some cases of depression require treating it with therapy or medicine or both, which will also resolve the physical symptoms. Jus

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

t make sure to inform the health care provider about any physical symptoms, and don’t assume that it will go away on its own. It may need a

.

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

ditional treatment; the doctor may recommend antianxiety medications for insomnia that will help in relaxation and better sleep. Other treat

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

Companies that provide selfless information through particip

ents can also help with the painful physical symptoms of depression such as focused therapy that can teach ways to cope better with the pain

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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