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Recent evidence shows a direct link between Acid reflux and sleep apnea. Studies show that a great many people who suffer from Acid Reflux Disease or GERD (

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

Gastro Esophageal Reflux Disease) report worse symptoms at night. The question still asked, though, is which came first. Since both conditions involve an

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

Examples of combination products may in

inflammation of the throat area, it is difficult to determine if one precedes the other.

In sleep apnea, the patient breathes harder because the breathing a

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

ctually stops. This labored breathing may cause reflux into the esophagus. But the question can be asked in reverse as well. Does acid reflux cause sleep apn

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

a by pooling in the esophagus and make breathing more difficult? Either way, the effects are the same and need to be addressed.

If the acid reflux is the ro

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

Combination pro

ot of sleep apnea, then it can be remedied through sleep positioning and diet therapy. Sleep positioning is where the upper body is elevated slightly to dete

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

r gastric contents from getting past the lower esophageal sphincter and into the esophagus. Basically, it’s a matter of offsetting gravity’s effect. Diet the

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

apy means that the sufferer shouldn’t eat spicy foods right before bedtime as this helps reduce gastric activity during sleep periods. Another factor may be

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

obesity. Diets rich in fats, grease or sugar are simply not healthy and should be adjusted.

So as you can see, this is a “chicken and egg” situation when it

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

comes to finding out which came first with acid reflux and sleep apnea. Studies are being done in this area and the findings will be reported to the gastroe

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

terology community on completion.

One such study done recently found a “casual” relationship between GERD and sleep apnea. This researcher is planning anoth

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

Following aspects would a

er, more detailed, program to actually measure the acidic content of regurgitated material into the esophagus. It may be that it isn’t just acidic content, b

dd to the challenges in developing combination products:

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

ut liquids ingested that are at the center of the problem.

Either way this goes, the result is similar. Material passes from the stomach into the esophagus,

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

possibly up to the throat or mouth and causes obstructive sleep apnea to occur. On the other side, a sufferer of sleep apnea may encounter trouble breathing

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

while asleep and this may facilitate the reflux.

It is estimated that more than 20% of Americans with weekly heartburn symptoms have GERD. When these people

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

go to sleep, problems seem to intensify.
So if you suffer from GERD and have noticed a problem with your sleep patterns, there are a few things you can

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

Professional from academic institutions, pharmaceutical industries, health care indust

do for yourself.
1. See a doctor immediately and get a formal diagnosis.
2. Watch your food intake.
3. Look for extreme symptoms occurring

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

at night. Document these for your physician.
4. Try relaxation techniques to relieve stress. Meditation has been used successfully.
5. Elevate 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 head and neck slightly to avoid the reflux of gastric content into the esophagus.

In any case, if you have acid reflux and sleep apnea, see your family do

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

Companies that provide selfless information through particip

ctor for further details and help with your condition. It could mean the difference between a good night’s sleep and lying there awake wondering what’s wrong

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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