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Anxiety related disorders are a common problem for people who are suffering from post traumatic stress disorders (PTSD). People who suffer from various forms of PTSD ex

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

pect a reoccurrence of the events or similar circumstances that originally caused the original injury. For people who suffer from chronic and chronic delayed PTSD this

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

Examples of combination products may in

anxiety is never ending daily experience.

Anxiety from PTSD may be manifested in simple daily activities. As an example many combat vets suffering from PTSD have a har

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

d time just simply stopping their vehicle to purchase a tank full of gas. They drive from one gas station to another looking for the right location. Occasionally they e

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

ven run out of gas rather then stop. They fear that they feel very vulnerable and that they will be ambushed or attacked while caught out in the open at the gas station

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

Combination pro

. The anxiety and stress associated with this simple exercise of daily life simply drains the sufferer of energy and may initiate intrusive thoughts or even flashbacks

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

all of which greatly increase anxiety levels.

Post traumatic stress disorder related anxiety comes in other forms as well. Many PTSD suffers also have a sleep deprivat

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

on problems that result from the fear of falling a sleep and being vulnerable to attack. Similarly they fight sleep in order not to dream. Most combat vets and accident

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

victims have repeated nightmares that cause the sufferer to wake up in a sweat and are unable not to return to sleep. Anxiety mounts as exhaustion nears leading to int

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

rusive episodes and even flashbacks to the original traumatic events. This cycle ends when the sufferer slips into an exhausted sleep. Many sufferers use self medicatio

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

n in an effort to escape or control the nightmares and intrusive thoughts. The goal of the sufferer is to reduce the affects of Anxiety and PTSD.

Self medicating for a

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

Following aspects would a

nxiety will lead to further problems. The most common source of self medication is alcohol which in many cases does temporarily reduce the anxiety level but allows the

dd to the challenges in developing combination products:

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

PTSD sufferer to act out on some of the intrusive thoughts and frustrations. The biggest downside of using alcohol to self medicate is the resulting depression that fol

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

lows. Self medicating with drugs and alcohol also limits the effectiveness of standard PTSD therapy. Health risks and the high risk of suicide are also major issues tha

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

result from self medicating for the anxiety.

Anxiety that is associated with post traumatic stress disorder is very treatable however the PTSD may not be totally cura

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

ble. The goal of treatment is to prevent the anxiety and PTSD symptoms from controlling the sufferer’s life. Unless the PTSD sufferer surrenders to a good treatment pro

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

Professional from academic institutions, pharmaceutical industries, health care indust

gram like one administered by the Department of Veterans Affairs, he or she will continue to suffer needlessly. The treatment regime includes using the latest drugs to

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

control anxiety, increase rest, reduce nightmares and intrusive thoughts. A program of education and counseling follows once the patient responds to drug therapy. Trust

.

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

is a major issue with many PTSD sufferers. Unless the PTSD sufferer feels safe and trusts the people who are treating he or she then they will not surrender to the tre

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

Companies that provide selfless information through particip

atment process. Anxiety and post traumatic stress disorder issues will continue to dominate their life

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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