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No sane person wants to live with chronic pain. The adverse side effects of reckless consumption of painkillers

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

are now driving many sufferers to pain management clinics. These clinics provide multiple approaches to pain man

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

Examples of combination products may in

gement for the best possible results. According to a survey, nearly 60 percent of people with chronic pain under

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

going treatment in a pain clinic for a year experience a significant reduction in their sufferings.

Some pain m

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

nagement clinics focus on a single method of treatment, like the injection of steroids to reduce inflammation, h

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

Combination pro

adache or back pain. Others provide more varied types of approaches.

Many clinics these days use multiple treat

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

ment providers employing specialists from various areas of medicine, who share information and coordinate care f

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

r the best possible results. These health care providers might include a neurologist, anesthesiologist, internis

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

t, family physician, physical medicine specialist, psychologist, psychiatrist and physical therapist.

Medicatio

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

s prescribed by a doctor in a pain clinic program include pain medications, nonsteroidal anti-inflammatories (NS

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

ID), steroids to reduce inflammation, muscle relaxants or anti-anxiety medication to reduce tension, and antidep

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

Following aspects would a

ressants or anti-convulsants to help control specific types of nerve pain.

Pain clinics may also offer non-drug

dd to the challenges in developing combination products:

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

therapies including individual and/or family therapy, hot and cold therapy, physical therapy, biofeedback, massa

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

ge, acupuncture, breathing exercises, self-hypnosis and TENS (Transcutaneous Electrical Nerve Stimulation).

You

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

must check whether the clinic is accredited or not before making a decision. Accreditation ensures that the prog

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

am fulfils the basic requirements for appropriate medical care. Certification by the American Academy of Pain Ma

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

Professional from academic institutions, pharmaceutical industries, health care indust

nagement indicates that the clinic has gone through a thorough peer-reviewed compliance process that was establi

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

hed by pain practitioners. You should also look for certification by the American Board of Anesthesiology and th

.

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

e American Board of Pain Medicine.

Johns Hopkins Center, Mensana Clinic, Cleveland Clinic and Mayo Clinic are a

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

Companies that provide selfless information through particip

ong the top pain clinics in the United States. Consult your physician to decide which one is appropriate for you

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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