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Psoriasis is a chronic skin disease of scaling and inflammation that affects as many as 7 million people in the United States. This long-lasting disease is found in all age groups but primarily affects

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

adults and appears equally in males and females.

Psoriasis takes place when skin cells rise quickly from their origin under the skin and pile up on the surface before they have a chance to mature. Thi

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

Examples of combination products may in

movement called turnover usually takes about a month but in the case of psoriasis can occur in only a few days. In its typical form, the disease results in patches of inflamed skin covered with silver

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 scales called plaques which itch and feel sore in many areas of the body including the scalp.

PSORIASIS and the IMMUNE SYSTEM:: This skin disorder is driven by the immune system, especially involving

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

a type of white blood cell, called a T cell. T cells normally help guard the body against infection and disease. With psoriasis, T cells are moved to action by mistake and become so active that they tr

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

Combination pro

igger other immune responses which lead to inflammation. In a significant number of cases, there is a family history of the disease. Studies of a large number of families affected by psoriasis have iden

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

ified genes linked to the disease. There are times when people with psoriasis find that their skin gets worse, then gets better. Flareups may be caused by infection, stress and climate changes that dry

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

the skin.

PSORIASIS and the QUALITY of LIFE: Unfortunately, individuals with the disease may experience physical discomfort, even some disability. Pain and itching can interfere with self-care, walki

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

g and sleep. Plaques on hands and feet can prevent working at certain occupations and caring for family members. The frequency of medical care is costly and may interfere with work or school schedules.

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

People with moderate to severe psoriasis may feel self-conscious about their appearance and reflect a poor self-image that grows out of fear of public rejection. Such psychological distress can lead

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

o depression and social isolation.

DIAGNOSING PSORIASIS: From time to time, it may be difficult for doctors to diagnose the disease because it often looks like other skin disorders. It can take severa

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

Following aspects would a

l forms: skin lesions covered by silvery scales; small drop-like lesions, often triggered by upper respiratory infections; blisters of non-infectious pus, possibly triggered by stress, medications, infe

dd to the challenges in developing combination products:

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

tions or exposure to certain chemicals. Widespread reddening and scaling of the skin may be a reaction to severe sunburn or to taking cortisone or other medications.

TREATING PSORIASIS: Doctors genera

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

lly treat psoriasis in steps based on the severity of the disease, the size of the areas involved, the type of the psoriasis and the response of the patient to initial treatments. The three-step approa

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

h: First, medications are applied to the skin; then light treatments (phototherapy) are given and the last step involves taking medicines orally or injections that can treat the whole immune system. S

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

adly, affected skin can become resistant to treatment over time, often when topical corticosteroids are employed. Yet a treatment that works well in one patient may have little effect in another. Doctor

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

Professional from academic institutions, pharmaceutical industries, health care indust

often use a trial-and-error method to find a treatment that works. They may switch treatments periodically if a treatment does not work or if adverse reactions occur.

HOPE for PSORIASIS SUFFERERS: The

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

re are promising areas of research. Progress has been made in understanding the inheritance of the disease. A number of genes involved in psoriasis are already known or suspected. In a disease involv

.

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

ng genes, environment and other factors, variations in one or more genes may produce a greater likelihood of getting the disease. Since discovering that inflammation in psoriasis is triggered by T cell

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

Companies that provide selfless information through particip

s, researchers have been studying new treatments that quiet immune system reactions in the skin. Among these are treatments that block the activity of T cells or block proteins that promote inflammation

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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