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I am one of the 35,000,000 Americans who suffer from chronic sinusitis. I’ve looked at numerous potential sinusitis cures over the years and have undergone two painful sinus operatio

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

ns. I still was coming down with sinus infections after that, which was pretty discouraging, and I had to make lifestyle changes I wasn’t pleased with. Over the past four years or s

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

Examples of combination products may in

o I’ve found help using pulsating nasal irrigation with a saline solution, and the situation is relatively “under control”. I still get clogged up most nights, however, and have to t

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

ake several medications, including a steroid spray.

Research has been done by the Mayo Clinic in the hope of finding new sinusitis cures. I’ve been in touch with one of the physicia

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

s on the Mayo Clinic research team who advised me that there is a new therapy which may actually treat the root cause of chronic sinusitis in many people. In this article I’ll summar

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

Combination pro

ize in layman’s terms the results of the research.

The research showed that people with chronic sinusitis have a different immune response in their nasal cavities to naturally occurr

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

ing fungi, which they showed is present in the nasal cavities of almost everyone. The research team was able to demonstrate that in some people (chronic sinusitis sufferers) certain

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

hite blood cells, known as eosinophites, activate and thereby produce a chemical, called MBP, which causes damage to nasal membranes. Bacteria can then invade the damaged areas and c

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

ause sinus infections. It therefore made sense that an option in the search for new sinusitis cures would be to treat the fungus rather than treat the bacteria with an antibiotic, wh

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

ich is often the therapy followed conventionally.

Mayo Clinic studies have shown that 75% of chronic sinusitis sufferers saw improvement when treated with a topical fungicide. The T

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

erapy is called topical antifungal therapy. An antifungal called Amphotericin B has already been approved by the FDA for other treatments and is normally administered to patients as

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

Following aspects would a

an injection. For sinusitis cures it is made into a topical nasal spray and applied daily. The recommended dose is 100 micrograms/ml. This medication is generally not available in

dd to the challenges in developing combination products:

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

most pharmacies today. One must get the prescription filled through a compounding pharmacy such as Anazao. The best thing to do is find a physician who is trained in administering

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

this therapy, and that doctor can no doubt explain how to obtain the medication prescribed.

In some people the eosinophiles do not react to fungi present in the nasal mucus, and the

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

e people generally do not have chronic sinusitis. Why the eosinophiles act differently in different people is not yet known. Also, it is difficult to administer a test which will tel

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

l if one person has this type of reaction occur in his body or not. However, this theory would explain why some people are chronic sinusitis sufferers even after extensive convention

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

Professional from academic institutions, pharmaceutical industries, health care indust

al treatments or sinus operations. The conventional therapies and surgeries to date have simply not addressed this issue, since it was not known prior to the Mayo Clinic studies and

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

atient tests.

Chronic sinusitis sufferers should be aware that this new therapy is available today in some locations, that it is gaining popularity, and it is becoming part of the ar

.

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

senal of sinusitis cures available. People desperate for help should try to locate a physician who has been trained to administer this treatment and determine if it would help in the

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

Companies that provide selfless information through particip

ir case. If you cannot locate such treatment in your area, please go to http://www.postnasaldrip.net and click the Contact Us button and we’ll try to help, but travel may be 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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