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Depending on the diagnosis and the severity of the symptoms of depression, there are several types of treatments that might be recommended by your health care professional. The most common include various types of psychotherapy and anti-depressant medications, o

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

r perhaps a combination of these two approaches. For very severe cases of depression, more drastic measures can be employed.

The following is a brief description and explanation of the main options recognised as being effective in the treatment of depression and

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

Examples of combination products may in

depressive disorders.

Psychotherapy

This approach is based on developing a trusting, safe and understanding environment for you to talk through your thoughts and feelings with the help of a trained counsellor. By sharing your experiences either on a one to one

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

basis or perhaps in a group therapy session with people in a similar situation or with similar feelings, can allow you the necessary emotional support you need to enable you to cope. This type of treatment lends itself well to mild and moderate types of depress

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

on sometimes alongside medication.

Cognitive Behavioural Therapy

Sometimes negative thoughts and ideas or the way you think about things can contribute to feelings of depression. This type of therapy helps you to look at these in detail in order to change the

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

Combination pro

way you think about them, so that you change your behaviour accordingly. By focussing on specific difficulties that are happening in your life now, new ways of coping and dealing with situations can be identified. It is particularly helpful for anxiety related a

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

d panic disorders and disorders affecting behaviour, for example, obsessive compulsive disorder and eating disorders, amongst others.

Anti-depressant medication

Persistent depression may require the use of anti-depressants for a period of time. Just like all tr

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

eatments, they are not an overnight fix and can take anything up to several weeks for the effect of the medication to be felt, and just like all medications they can carry side effects.

There are many kinds of anti-depressants available but the four main types f

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

ll into the categories of:

• Tricyclics – including Anafranil

• Selective Serotonin Reuptake Inhibitors – SSRIs like Prozac

• Serotonin and Noradrenaline Reuptake Inhibitors – SNRIs such as Endronax

• Monoamine Oxidase Inhibitors – for example, Manerix and Na

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

rdil

Basically, they are all believed to work by impacting on the activity of the chemicals in the brain responsible for making us "feel good" such as Serotonin and Noradrenaline. The most commonly prescribed anti-depressant drugs today fall into the SSRI categ

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

ry as they appear to have fewer side effects and are considered less dangerous than the others.

Lithium Carbonate has a mood stabilising effect and is sometimes prescribed to people with severe depression; however, it is dangerous if the levels in the blood beco

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

Following aspects would a

me too high so constant medical checks and blood tests are a necessity.

St John's Wort is a herbal remedy that has gained a lot of recognition in recent years for being effective in cases of mild to moderate depression and anxiety and is already widely used in G

dd to the challenges in developing combination products:

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

rmany. It appears to work in much the same way as Prozac by inhibiting the reuptake of Serotonin in the brain.

Electro Convulsive Therapy

The National Institute for Health and Clinical Excellence (NICE), recommend that ECT is only used "for the treatment of se

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

vere depressive illness, a prolonged or severe episode of mania, or catatonia" but certain conditions apply including one that other forms of treatment have proved ineffective. It is a controversial procedure that involves placing electrodes on the head and admin

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

stering a short electrical shock to the brain. The person receiving ECT is given an anaesthetic and muscle relaxants beforehand. It is usually given in twice weekly sessions over a period of several weeks and possibly monthly after that to prevent a relapse. Th

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

e most common and distressing side effect reported is long term and/or short term memory loss.

Experimental Treatments

Vagal Nerve Stimulation is a treatment that is used in cases of Epilepsy but has also been found to be effective in the treatment of severe de

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

Professional from academic institutions, pharmaceutical industries, health care indust

ression. Although still classed as experimental, in 2005 it was approved by the FDA in the USA for severe treatment-resistant depression. One of the main differences with this type of treatment and others is that it takes quite some time for the effect to be no

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

ticed, up to a year or even two years in some cases, however, the indications are that those receiving the treatment appear to stay better for longer. A nerve stimulator similar to a heart pace maker, is placed in the chest where it delivers regular electrical i

.

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

pulses to the Vagal nerve in the neck, which in turns stimulates the brain. No one really understands why it appears to be effective or exactly how it works but research by Dr.Charles Conway, assistant professor of psychiatry at Saint Louis University School of M

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

Companies that provide selfless information through particip

edicine, who led a four year research project into Vagal Nerve Stimulation from 2000 to 2004, found that it appears to produce the same type of effect in the brain as ECT, but that the effect doesn't seem to wear off as it does with ECT. More research is required

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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