E-Articles - Health and Fitness

There has long been a debate over whether binge eating presents a gastric bypass risk and increases the poss

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

ibility of a poor outcome following surgery. A recent report published in the Journal of Clinical Psychiatry

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

Examples of combination products may in

may however shed new light on this argument.

The study carried out at the Yale University School of Medicin

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

e involved nearly 140 extremely obese patients and looked at their eating habits prior to surgery and then f

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

llowed them up during the twelve months after gastric bypass surgery.

Of the study group, some 40 patients

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

Combination pro

reported binge eating in the month before their operation and approximately ten percent of the study group w

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

re classified as meeting the criteria to be diagnosed as having binge eating disorder. It was also noted tha

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

t those people classed as binge eaters were considerably more nervous about their impending surgery than the

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

non-binge eaters.

Following surgery the study noted that there was no difference of note between the two gr

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

oups and that both binge eaters and non-binge eaters showed virtually identical weight loss profiles in the

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

welve months after their gastric bypass.

Prior to surgery the average body mass index was 51.7, placing the

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

Following aspects would a

group well over the body mass index figure of 40 which defines extreme, or morbid, obesity. One year after s

dd to the challenges in developing combination products:

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

urgery this figure had fallen to just 33.3, bringing many of those in the study group close to a normal body

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

mass index.

Also of importance, this study reported that, although some of the binge eaters did experience

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

slightly elevated, but relatively easily managed, eating related disturbances after surgery, their pre-surgi

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

al anxiety had reduced considerably and there was little if any difference at all between binge eaters and n

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

Professional from academic institutions, pharmaceutical industries, health care indust

on-binge eaters in terms of depression following surgery.

While the results of the study are of course enco

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

raging, it should be remembered that the study has only followed this group of patients for a period of twel

.

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

ve months so far. It will be necessary to see this, and other studies, running over a period of several year

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

Companies that provide selfless information through particip

following gastric bypass before we can be sure that these initial results will hold true in the longer term

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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