New device approved by FDA for migraines

The FDA approved a headband-like device that helps prevent migraine headaches.

ON Tuesday, the Food and Drug Administration announced its approval of a device for preventing migraines.

Called Cefaly, it's the first transcutaneous electrical nerve stimulation (TENS) device designed for use prior to the crushing pain of such headaches.

Migraines are defined as throbbing or pulsing pain in one area of the head, and symptoms can include sensitivity to light and sound, and nausea. A migraine lasts four to 72 hours if untreated.

"Cefaly provides an alternative to medication for migraine prevention," Christy Foreman, director of the Office of Device Evaluation at the FDA's Center for Devices and Radiological Health, said in a statement.

"This may help patients who cannot tolerate current migraine medications or treating attacks."

The small, battery-operated, portable device resembles a plastic headband. It's placed on top of the ears and worn across the forehead, delivering electrical impulses to stimulate the trigeminal nerve.

This nerve is believed to contribute to migraine pain. According to the FDA, the device should be worn once daily for about 20 minutes and is intended for those 18 and older.

The FDA approved the device following a small clinical study in Belgium involving 67 people. Participants experienced at least two migraines per month and hadn't taken drugs to prevent the headaches for three months prior to the study.

While Cefaly didn't prevent migraines completely, it did help participants experience fewer "migraine days" per month. Most common issues were tingling sensations and sleepiness during device use, and subsequent headaches. The FDA reported no serious side effects.

A patient satisfaction survey asking 2,313 Cefaly users in France and Belgium to rate the device found about 53% satisfied with Cefaly treatment and willing to purchase the device.

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Everything you should know about migraines

This article discusses many aspects of migraines such as what causes them and how to treat them.

Migraines can loosely be described as recurrent moderate to severe headaches that is typically unilateral, that is, pain occurring on side of the head. Associated symptoms may include nausea, vomiting, photophobia (increased sensitivity to light), phonophobia (increased sensitivity to sound) and the pain is generally aggravated by physical activity. Up to one-third of people with migraine headaches perceive an aura: a transient visual, sensory, language, or motor disturbance which signals that the headache will soon occur. Occasionally an aura can occur with little or no headache following it.

What causes migraines?

The underlying causes of migraines are unknown. However, they are believed to be related to a mix of environmental and genetic factors. They run in families in about two-thirds of cases and rarely occur due to a single gene defect.

There have been stipulations that migraines are caused by expanded blood vessels in the brain. However, the pain of migraine headaches might not be caused by expanded blood vessels in the brain, as previously thought. Instead, the real culprit may be overactive pain-signal firing in brain cells, new research suggests. These findings were published on April 9th in the journal Lancet Neurology, come from studying the brain scans of patients as they were suffering from a migraine.

Moreover, there are several treatments being developed that could address this signaling and, in turn, help treat migraine pain. However, further studies are needed to confirm that the overactive signaling is a cause of migraine pain.

How can migraines be cured?

Preventive migraine medications are considered effective if they reduce the frequency or severity of the migraine attacks by at least 50%. Common drugs used in Ghana to help with the pain are Cafergot (combination of drugs; ergotamine tatrate and caffeine), topiramate, propranolol, and metoprolol. Other household methods that can help are as follows:

a. Getting a good night’s sleep

b. Keep the room dark

c. Take Caffeine; it's a paradox of headaches: ingest too much caffeine and you may get a headache, but take a little bit and it can help make the pain disappear

d. Ice packs. Lie down and put an ice pack or cold compress on your head. Close your eyes while doing that.

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Chili peppers may help develop next migraine medicine

This article discusses chili peppers as a potential treatment for migraines and compares it with the success of botox injections used to treat migraines.

Chili peppers and migraines have traits in common, a fact scientists are exploiting to develop drugs capable of preventing the debilitating headache’s painful symptoms before they attack.

The link between how skin reacts when rubbed with chili oil and what happens in the brain during a migraine has attracted the world’s largest biotechnology company, Amgen Inc. (AMGN), and other companies seeking to create medicines for the more than 36 million Americans who suffer from migraines.

Symptoms include nausea, vomiting, dizziness and sensitivity to touch, yet treatment options are limited. Some pharmaceutical companies that have tried recently to develop migraine therapies, such as Bristol-Myers Squibb Co. (BMY)and Merck & Co. (MRK), have abandoned their efforts while the few drugs on the market are ineffective for many people and carry the danger of serious side effects for those at risk of heart attack or stroke.

“Migraines are an extremely common disorder, and it affects people really in the prime of their lives,” Rob Lenz, who is leading Amgen’s migraine drug development, said in an interview. Still, no drugs have been “developed specifically for the treatment of migraines,” he said. “They were developed as anti-epileptics, or blood pressure lowering agents.”

That may soon change. Amgen, based in Thousand Oaks,California, and other biotechnology companies such as Alder Biopharmaceuticals Inc., Arteaus Therapeutics LLC, and Labrys Biologics Inc. are targeting a chemical released during a migraine that carries a “pain” signal from nerve to nerve. By blocking a receptor from receiving the message, these companies aim to create drugs that cut off developing migraines before symptoms start.

Targeted Injections

Similar pain-signal transmission occurs when chili oil touches the skin. In that situation, the capsaicin in the pepper causes the body to release calcitonin gene-related peptides, or CGRP, leading to an increase in blood flow to the affected area. To show the Amgen drug works, researchers injected it under the skin of patients who had chili oil on their skin. The therapy blocked the CGRP that causes increased blood flow.

“It sounds simple, but it’s important -- it tells us that our drug is getting into the body in relative concentrations that are generally well tolerated and that block CGRP,” Lenz said.

The new class of drugs under development are biologics, often delivered by injection, and are more complex, targeted and longer lasting in the body than the earlier failed attempts, Lenz said.

Sales Potential

Amgen’s AMG 334 and Alder’s ALD 403 are being tested in the second of three clinical trials typically required for U.S. regulatory approval.

“We’ll have data on this before the year is out,” Randall Schatzman, chief executive officer of closely held Alder, based in Bothell, Washington, said in an interview.

If those trials yield results, the sales potential for these drugs will be significant. Michael Yee, an analyst with RBC Capital Markets in San Francisco, said Amgen’s new migraine treatment may reach $1 billion in sales should it gain approval.

Allergan Inc. (AGN)’s Botox, used primarily for cosmetic treatments, is also approved as a preventative therapy for migraines, though only for severe sufferers who have attacks lasting four hours or more at least 15 days a month. That means only about 10 percent of migraine patients qualify for that option. Sales for Botox as a migraine treatment alone could reach $1 billion during the next decade, Anne-Elise Tobin, an analyst with Burlington, Massachusetts-based Decision Resources, said in an interview. The new class of drugs would be for a bigger patient population with less frequent migraines.

Botox Success

“Botox demonstrates the market potential for a new emerging prophylaxis therapy,” said Tobin, who estimates the global market for all migraine treatments should increase 87 percent to $5.8 billion in 2021 from $3.1 billion in 2011.

Amgen gained 1.8 percent to $113.42 in New York. The stock gained 34 percent in 2012, its best annual increase since 1999, as investors rewarded the company for its buyback program, dividend and sales increase.

Currently, the most popular migraine treatments are oral drugs called triptans, first introduced in the 1990s, such as GlaxoSmithKline Plc’s Imitrex, which constrict blood vessels in the brain to relieve swelling and pain.

Pain Blockers

Those medicines attempt to halt migraines once they begin. The new therapies aim to eliminate the need to wait for attacks to occur, said John Latham, chief scientific officer at Alder.

“Once the migraine symptoms flair, it’s very hard to resolve them, and most of the people at that stage of the game let it run its course,” Latham said in a phone interview. “You can go into a dark room, turn the lights off, put ear plugs on, use an ice pack, but there’s not much you can do pharmaceutically to kick the migraine back in its place.”

That’s why the new pain blocker approach holds so much promise. By blocking a receptor in the brain from receiving the message, migraines could be avoided completely, said Peter Goadsby, director of the University of California, San Francisco’s Headache Center. Goadsby helped discover CGRP’s connection to migraines and has consulted with drug companies working on developing his findings into medicines.

“What these antibody approaches hope to do is to either block the receptor or mop up the CGRP itself,” he said.

This isn’t the first time drugmakers have targeted CGRP to stop migraines. Bristol-Myers and Merck were working a few years ago on so-called small molecule therapies, taken orally, to prevent headaches. While Merck’s drug, telcagepant, worked better than a placebo in a study, the company shelved development on concerns about liver damage. Bristol-Myers also said it wouldn’t continue development of its drug.

“The whole migraine world was thrown into a tizzy because this was supposed to be the next big thing,” Cathy Glaser, president and co-founder of the Migraine Research Foundation, said in an interview. “We’re all looking for the next magic pill.”

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Vitamins that can help treat or prevent migraines

This article outlines three vitamins that may help prevent migraines.

If you suffer from migraines and are looking for a way to prevent them, adding riboflavin, magnesium, and/or CoEnzyme Q10 (CoQ10) to your diet could make them less frequent.

Riboflavin

Studies show that migraine sufferers who take 400 milligrams (mg) per day of riboflavin (vitamin B2) appear to get significantly less migraine headaches. Taking riboflavin does not seem to reduce the pain level or length of a migraine, however. In one study, people who took riboflavin had more than 50 percent fewer headaches.

Riboflavin is essential for the body’s energy production at the cell level. Some research suggests that migraine sufferers may have a genetic defect that inhibits their cells' ability to maintain energy reserves. Insufficient energy could trigger migraines.

It can be difficult to consume enough riboflavin in your diet to prevent migraines. Foods that contain riboflavin include:

• brewer's yeast
• eggs
• enriched flour
• green vegetables
• meat
• milk
• mushrooms
• nuts
• organ meats
• soybeans
• wheat germ
• whole grains
• wild rice
• yogurt

Magnesium

Migraine sufferers often have lower magnesium levels than people who don't get them. Several studies show that magnesium may reduce the frequency of migraines in individuals who have low magnesium levels. Some studies also suggest that magnesium may help women who get migraines along with their periods.

The body requires magnesium, a mineral, to sustain normal muscle and nerve function, maintain heart rhythm, keep a healthy immune system and develop strong bones. Magnesium is integral in at least 300 biochemical reactions.

Adding 200 to 600 mg of magnesium to your diet daily might help to prevent migraines. Magnesium can cause diarrhea, however. Take a lower amount if this is a problem.

Magnesium relaxes the arterial walls, which allow blood and oxygen to flow more freely. This helps to reduce stress, which is a huge migraine trigger.

Foods high in magnesium include:

• avocados
• bananas
• dark chocolate
• dried herbs
• dark green vegetables
• molasses
• nuts (almonds, peanuts, cashews)
• oats
• raisins
• rice
• seeds (sunflower seeds, pumpkin seeds)
• wheat
• whole grains

CoEnzyme Q10

Studies suggest that CoQ10 may help to reduce the number of migraine attacks. One study showed that individuals who took CoQ10 got 50 percent less migraines.

CoQ10 helps to create energy inside the body's cells. Low energy production can result in migraines.

Take up to 300 mg of CoQ10 daily to prevent migraines, in two or three doses.

Don't take CoQ10 if you have bleeding disorders or diabetes, or are using blood thinners. CoQ10 can alter how your blood clots and change blood sugar metabolism.

Foods containing CoQ10 include:

• beef
• chicken
• eggs
• nuts
• oils
• pork
• seeds

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Black mamba venom for migraines?

"Mambalgins"! I like it. JR


A study by French scientists showed that black mamba venom and venom from other poisonous creatures could work effectively as a painkiller for migraines without the harmful side effects of other painkillers.

A team of French scientists has found that black mamba venom, which is considered to be among nature’s most deadly toxins, is a highly effective painkiller that won’t cause the troublesome side effects of opiates.

The journal Nature published research today that outlines how proteins in the toxic venom called mambalgins tested as effectively as morphine in lab mice. It also lacks properties that would cause addiction, cognitive dulling, headaches, and other a number of other undesirableconditions.

“Mambalgins are not toxic in mice but show a potent analgesic effect upon central and peripheral injection that can be as strong as morphine. This effect is, however, resistant to naloxone, and mambalgins cause much less tolerance than morphine and no respiratory distress,” the report states.

Black mamba venom isn’t the only toxin that’s being developed for managing pain. Toxins from snakes, spiders, and even scorpions are being evaluated as potential cure alls for our aches and pains. Bee stings are already being used to treat arthritis. Here are some examples:

Johnson & Johnson and Australia’s University of Queensland are partnering on a drug that uses peptides found in spider venom to treat chronic pain; Canadian’s Wex Phamanceuticals has built its company around puffer fish poison; and cobra venom has been found to ease arthritis pain. Israeli researchers are evaluating scorpions as a potential source for non opiate painkillers.

Having so many alternatives could be a prescription against the substance abuse and crime that’s associated with today’s mainline drugs. Painkiller abuse is rapidly becoming an epidemic across the United States, and now accounts for more annual deaths than cocaine and heroin overdoses.

Having safer, effective alternative available for people who really need it is desirable - even if the new drugs are pricier. It is worth asking whether the added cost of a brand name drug vs. generic opiates would surpass the harm that prescription drug addiction is inflicting upon people and society.

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