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As of late the molecule SAM-e has become known as a natural treatment for depression, the number one mental disorder in terms of affected patients world-wide. Today

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

various medicinal treatments for depression exist ranging from well known prescription drugs such as the Serotonin-Reuptake-Inhibitors, to so-called natural treatm

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

Examples of combination products may in

nts for depression. A natural treatment for depression is loosely defined as a medicinal agent that is not a prescription drug and commonly of natural origin such a

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

herbal treatment for depression, fish oils or, as in the case of SAM-e, an agent that is chemically synthesised for treatment purposes, but also occurs naturally i

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

the body. (As an aside it needs to be pointed out that prescription drugs often are also derived from organic sources, including plants, so the definition of “natu

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

Combination pro

ral” is actually quite imprecise).

SAM-e
SAM-e (S-Adenosyl Methionine) is an essential amino acid that is naturally produced in the human body, and primarily

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

he liver, where it is also metabolized to a large extent. It plays a central role in the body’s metabolism, where it is involved in the transfer of Methyl-groups to

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

various substrates such as proteins, nucleic acids and lipids. Among its many effects in the body this natural treatment for depression increases the level of neur

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

transmitters in the brain. Discovered in the 1950s SAM-e has been known as a treatment for various diseases since the 1970s. With an increasing awareness for depres

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

sion and a growing tendency for self-medication the compound has recently received more and more attention as a potential alternative treatment for depression.

Thi

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

natural treatment for depression is sold in the US as a nutritional supplement rather than as prescription drug, although, as will be seen later, its side effect p

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

Following aspects would a

ofile is not to be underestimated. The compound is marketed as either SAM-e or under other trade names such as Gumbaral, Samyr, Adomet and Admethionine. Apart of be

dd to the challenges in developing combination products:

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

ng marketed as natural treatment for depression SAM-e is also sold as remedy for liver diseases and osteoarthritis. It is commonly taken in the form of a pill at va

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

rious concentrations. As for the compound’s potential as alternative treatment for depression various clinical studies have shown its positive effect on depression.

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

Many users of SAM-e reported that this natural treatment for depression improved their symptoms significantly; while others stated that there depression even disapp

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

ared completely. However, the compound is not without its risks as in some patients it can cause neurological conditions such as worsened depression, anxiety, mania

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

Professional from academic institutions, pharmaceutical industries, health care indust

nausea and headaches as well as other organic side effects such as diarrhoea, dyspepsia, insomnia and allergic reactions. It may also lose its potency over time as

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

the patient’s body adjusts to the chemical. Long term effects of SAM-e are unknown.

Concluding it can be said that SAM-e may be a viable natural treatment for dep

.

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

ession for a given depression patient. However, while not a prescription drug it is recommended not to take it without medical guidance. In particular it is importa

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

Companies that provide selfless information through particip

t to start taking this alternative treatment for depression at a low dosage, since overdosing is commonly reported often leading to the side effects mentioned above

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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