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Backpain and ESI are related to each other in that the latter is very often used to find out the true cause of the former. Back ache is a common pheno

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

menon and is generally a result of a strain or injury to the muscles and ligaments supporting the human spine. An Epidural Steroid Injection or ESI is

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

Examples of combination products may in

the most common type of injection given to patients suffering from back and neck pain. The pain in the back can be constant or intermittent and its 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.

ntensity may vary from a dull ache to a searing feeling.

In a large number of cases, back pain vanishes or can be cured within a few weeks. However,

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

in cases of chronic pain, medical advice is necessary. Patients having difficulty in passing urine or experiencing numbness in the back or genital are

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

Combination pro

a or weakness and pain in the legs or feeling unsteady while standing should see a physician immediately. Spinal injections are often used to find out

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

the true cause of the back pain and than to actually treat the pain. Injections which provide temporary relief are called therapeutic injections. In

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

ther cases spinal injections are used to diagnose the cause of the back pain. ESI is generally injection used to treat back pain.

The space between t

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

he covering of the spinal cord and the inside of the bony spinal canal is called the epidural space. An injection in this area ensures that the medica

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

tion moves across the whole of the spine and covers all the nerve routs and joints to relieve the back pain. ESIs are generally very effective 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

treatment and the true diagnosis of the back pain.

In most of the cases where spinal injections are used, a local anesthetic called lidocaine is used

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

Following aspects would a

. Lidocaine is a fast acting drug and its effects wear off in a couple of hours. So it is generally used as a diagnostic tool. Bupivacaine, another an

dd to the challenges in developing combination products:

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

esthetic is used to provide some relief from the back pain. Another commonly used injection is Cortisone. Cortisone is commonly injected with a local

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

anesthetic to reduce inflammation in the affected areas of the patient suffering from severe back pain.

An epidural steroid injection or ESI can be i

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

jected in three different ways. In the first case a caudal block is placed through the sacral gap which is the space below our lumbar spine. Than the

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

injection is placed into the epidural space. This type of block reduces the chances of puncturing the dura.

The most common method of giving an ESI t

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

Professional from academic institutions, pharmaceutical industries, health care indust

o reduce back pain is the translumbar approach. Under this method the needle is placed between vertebrae from the back. The third method is generally

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

used for diagnostic purposes. The transforaminal approach involves injection of the medication around a specific nerve root to find out the exact prob

.

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

lem area. The foraminae are small openings between your vertebrae through which the nerve roots exit the spinal canal and enter the body.

Spinal inje

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

Companies that provide selfless information through particip

ctions should not be used in the case of patients taking a platelet-inhibiting drug, such as aspirin or NSAIDs (non-steroidal anti-inflammatory drugs)

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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