I Advice - Health and Fitness

Carpal tunnel syndrome is a painful condition that is characterized by pain, numbness, tingling and paresthesia (pins and needles) in the thumb, index and middle fingers, with advanced cases reve

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

aling loss of strength and coordination.

Carpal tunnel is the most common nerve entrapment disorder and is generally caused by a muscle imbalance in the hand and wrist that results in the compre

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

Examples of combination products may in

ssion and impingement of the median nerve. Other contributing factors include direct or blunt trauma or injury to the wrist that can induce swelling, such as sprain or fracture; over activity o

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

f the pituitary gland; hypothyroidism; rheumatoid arthritis; mechanical problems in the wrist joint; work stress; repeated use of vibrating hand tools; fluid retention during pregnancy or menopau

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

se; or the development of a cyst or tumor in the canal. In some cases no cause can be identified.

There are many treatments for carpal tunnel syndrome including medication, exercise, wrist splin

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

Combination pro

ting, cortisone injections but most commonly surgery in the prescribed remedy. Although surgery is one of the most common options for treating this condition; however, it remains a controversial

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

choice and it is important to fully understand the risks and benefits involved. Surgery is by far the most invasive procedure and it merits careful forethought, as the success rate is not as high

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

as the medical industry would like people to think. The reason for this misdirection is often due to the fact that a surgeon will make between $4-5,000 for each 30-minute surgical procedure, a s

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

um that is not to be taken lightly.

The statistics listed below provide insight to the poor success rate often experienced by patients that are subjected to carpal tunnel surgery:

· ONLY 23% of

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

all carpal tunnel syndrome patients returned to their previous professions following surgery, according to the Bureau of Labor & Statistics and the National Institute for Occupational Safety & H

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

ealth (1997-2000 Statistics).

· Up to 36% of all Carpal Tunnel Syndrome patients require unlimited medical treatment.

· Carpal tunnel surgery has about a 57% failure rate following patients fro

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

Following aspects would a

m 1-day to 6-years. At least one of the following symptoms re-occurred during this time: Pain, Numbness, Tingling sensations. Source: Nancollas, et al, 1995. J. Hand Surgery.

There are multiple

dd to the challenges in developing combination products:

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

forms of surgery for carpal tunnel syndrome including “open” and “endoscopic” surgery, which is a less invasive incision made through the muscle in the palm that requires less time for post-opera

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

tive recovery. Post-surgery symptoms such as pain and numbness usually begin to improve in two to six weeks, depending upon the procedure, severity of symptoms, gender and age of the patient. Mu

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

cle coordination, control, and strength may initially worsen following surgery, and a return to pre-operative status may take several months. Significant improvement to pre-injury status may take

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

as much as two years to achieve, if it comes at all.

The optimal method of treatment for carpal tunnel syndrome is simple corrective stretches and exercises. The vast majority of patients do q

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

Professional from academic institutions, pharmaceutical industries, health care indust

uite well with conservative treatment and it is estimated that less than 1/4 require surgical intervention. Only in severe cases is surgery recommended, such as when there is persistent, debilita

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

ting pain or muscle atrophy / flattening.

The complications associated with surgery as well as the timeline to substantial recovery make it as last choice resort for most patients. Thankfully, t

.

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

here are numerous effective alternatives that are much less invasive, such as a good balancing exercise and stretching program for the hand (Flextend, Restore, Cats Paw, etc.), wrist and forearm.

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

Companies that provide selfless information through particip

Once the muscles are in balance, compression of the median nerve is eliminated and the symptoms disappear.

Be sure to consult your doctor before starting any type of exercise or therapy program

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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