Article Dump - Health and Fitness

What is MicroWick?
The MicroWick technique is an exciting new method for treating a variety of hearing disorders and

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

diseases. It cleverly allows medicine to be delivered directly to where it is needed, bypassing the time-consuming oral d

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

Examples of combination products may in

elivery method and its associated side effects. And because medicine is applied directly to the site, its effectiveness i

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

creases greatly.

There are several very useful applications of the MicroWick, including
• M?ni?re’s disease,
•

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

ringing in the ears (tinnitus), and
• certain types of deafness.

How does MicroWick treatment work?
MicroWick

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

Combination pro

is a minimally invasive procedure, done in an office setting and using local anesthesia. A laser is used to create a bloo

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

less opening in the eardrum, through which a tiny endoscope is inserted. Then a tiny tube is inserted in the tympanostom

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

y opening, creating a clear view of the round window membrane and the pathway though which the MicroWick is inserted. Now

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

medication can reach the round window membrane and diffuse into the inner ear fluids, treating inner ear disease.

After

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

he course of medication is complete, the tube and MicroWick are removed in a simple office procedure. The opening 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

eardrum heals soon after.

What are the benefits of MicroWick?
MicroWick treatment has several advantages over tradit

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

Following aspects would a

ional surgical procedures to achieve the same results:
• it is far less expensive than hospitalization for surgery,

dd to the challenges in developing combination products:

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

> • it is painless, and
• it is well tolerated by patients.

Most insurance policies cover the MicroWick procedure,

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

making it a realistic option for those who need a hearing-related surgery but are hesitant to undergo a traditional proced

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

ure.

Best of all, there are few complications associated with the MicroWick procedure, and the results have been excellen

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

. Using MicroWick to deliver the antibiotic gentamicin to the middle ear effectively relieves attacks of M?ni?re’s diseas

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

Professional from academic institutions, pharmaceutical industries, health care indust

e in 80% of those treated and preserves hearing in 95%. Specifically,
• 80% of patients experienced reduced vertigo

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

• Almost all patients experienced preserved hearing
• In 60% of patients the pressure and tinnitus were reduced

.

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

These excellent results show the efficacy of MicroWick. The very best results of treating M?ni?re’s disease with MicroWi

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

Companies that provide selfless information through particip

ck are achieved when treatment begin early in disease onset, when there is little damage to the inner ear from the disease

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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