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It sounds like something out of medieval times. Using leeches to treat every disease and condition known to man. But as it turns out leeches are actually very powerful for tr

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

eating a wide variety of ailments including knee osteoarthritis.

Knee osteoarthritis is a degenerative joint disease that results in the breakdown of the cartilage between t

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

Examples of combination products may in

he joints in the knees. This leads to pain, loss of range of motion and bone damage. There appears to be several origins of knee osteoarthritis including joint deformity, rep

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

eated injury, or excess weight. There is no cure for osteoarthritis so the focus is on treatments for the pain and reduction of continued damage to the joint.

And this is wh

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

ere leeches come in. Leeches secrete morphine, a potent pain killer. Leeches also secrete an anticoagulant which improves blood flow to the area where the leeches are applied

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

Combination pro

and an anti-inflammatory. Since inflammation is responsible for the symptoms of osteoarthritis, researchers believe that leeches might relieve pain in patients with osteoarth

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

ritis.

The U.S. Food and Drug Administration (FDA) classify leeches as medical devices and has approved them for microsurgery. The FDA is also involved in the regulation of

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

the transport and sale of leeches. In Germany there has been an estimated 70,000 treatments a year over the last few years with four to five used for each treatment. Most of

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

these treatments have been aimed at pain reduction in knee osteoarthritis.

Several studies have been conducted regarding the use of leeches for treating knee osteoarthritis

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

.

One study, reported in the Annals of the Rheumatic Diseases, focused on 16 patients with an average age 68. These patients had experienced persistent knee pain for more th

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

n six months. None had suffered any knee injuries and all had x-ray evidence of osteoarthritis. These patients were already treating their knee osteoarthritis with physical t

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

Following aspects would a

herapy, relaxation, diet and exercise.

In this study, part of the group was provided traditional treatment and the rest were treated with leeches. Four leeches were applied

dd to the challenges in developing combination products:

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

to the knee for 80 minutes. Pain levels were measured three days before and 28 day after the treatment. The results were rapid. Treatment with leeches resulted in pain relief

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

after three days and continued through the 28 day test period. The patients who received traditional treatment did not experience relief. There were no side effects noted fr

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

om the leeches and the patients reported that the initial leech bite was mildly painful.

A larger study was conducted involving 51 patients age 40 and above with knee osteoa

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

thritis with high pain. Four to six leeches were applied to the affected knee and were allowed to remain until they detached themselves, which took about 70 minutes. Then the

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

Professional from academic institutions, pharmaceutical industries, health care indust

patients rested the knee for 12 hours. Researchers then measured the patients’ pain, stiffness and range of motion after 3, 7, 28, and 91 days.

The results were similar to

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

the smaller study. The patients receiving leech therapy reported less pain, less stiffness, better function, and fewer total osteoarthritis symptoms through the full 91 days

.

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

that the researchers followed them.

These studies give hope for alternative treatments of knee osteoarthritis for reducing pain and increasing mobility. In order to properly

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

Companies that provide selfless information through particip

validate these studies additional research needs to be conducted over a longer period of time. But it appears that leeches do provide relief to knee osteoarthritis sufferers

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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