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Nearly 30 million Americans suffer from the debilitating, life-altering pain of migraine. Learn what causes the throb and how to stop it.

Who Gets Mig

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

raine

It’s not clear why some people develop migraines and others don’t. If both your parents are migraine sufferers, there’s a 75 percent chance you’ll be one, too.

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

Examples of combination products may in

f only one parent is, your risk drops to 50 percent. And if a distant relative complains of the headaches, there’s still a 20 percent chance you could end up a migraineur. (Tha

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

t’s the term used to describe a migraine sufferer.) Your gender may predispose you to migraines as well: Women are three times more likely than men to get this type of headache

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

What Happens

“The brain of a migraine sufferer is inherently more sensitive than the brains of others,” says Fred Freitag, D.O., associate

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

Combination pro

director of the Diamond Headache Clinic in Chicago—and himself a migraineur. “When this sensitive brain gets bombarded by outside and inside stimuli, cells in the cortex of the

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

brain become hyperexcited and start a process of electrical discharge.” As electrical impulses spread across the surface of the brain, chemicals that dilate blood vessels and i

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

nflame surrounding tissue are released and kick into action. These chemicals trigger a series of events that eventually produce the throbbing pain (usually on one side of the h

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

ad), nausea, and sensitivity to light and sound that are hallmark migraine symptoms. Before the headache comes on, about one third of sufferers also experience an aura—flashes

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

of light, blind spots or zigzag lines, or tingling in the face and arm.

What Can be Done

Avoiding triggers is the first step to heading migraines off. Headac

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

e experts usually have migraineurs keep a diary for two to three months to identify foods, external factors and behaviors that might be making their heads throb. Then they’re r

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

Following aspects would a

ady for action. “If you that know certain foods give you a headache, avoid them,” says Dr. Freitag. Also, get on a schedule. Eat at regular times and go to bed and get up at th

dd to the challenges in developing combination products:

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

e same time every day. If you go to bed at 11 and get up at 6 all week but sleep in on Saturday, your blood sugar will drop because you’re eating breakfast later. In addition,

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

our internal clock gets thrown off. “Both can stimulate a sensitive brain,” says Dr. Freitag.

Eat a healthy diet. Magnesium-rich foods, such as whole grain breads and pasta, m

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

ay help stave off migraines. And exercise regularly. Even 20 minutes of aerobic exercise a few times per week stimulates the production of endorphins, the brain’s natural paink

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

llers. Relaxation training, acupuncture and massage can help, too. If these measures aren’t enough, ask your doctor whether you are a candidate for medication. The good news: W

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

Professional from academic institutions, pharmaceutical industries, health care indust

ith a little trial and error, experts say, you can usually find relief.

Trigger Effect

Experts have identified a slew of stimuli that can cause migraine atta

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

ks. These range from preservatives to perfumes to changes in barometric pressure. In women, hormone levels are often to blame. “Their hormones peak, drop during ovulation and 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

hen climb again, and then fall just before menstruation,” says Robert Kunkel, M.D., a consultant in the department of neurology at the Cleveland Clinic Headache Center. “It see

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

Companies that provide selfless information through particip

s to be the fall of estrogen levels in the blood that excites brain cells, not hormone levels per se.”

Writer: Catherine Winters ©MediZine's Healthy Living, Second Quarter 200

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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