The first ever transdermal patch for the treatment of migraine to be submitted for FDA approval has suffered a setback. The experimental migraine medication, called Zelrix, is a single use “medical device” that differs from typical transdermal patches in that it is a proprietary controlled delivery system that uses an electric pulse to move the medication through the skin.

NuPathe, which describes itself as a “specialty pharmaceutical company developing innovative products for the treatment of neurological and psychiatric diseases”, first announced positive results from a Phase III clinical trial of Zelrix in August of 2009.

According to NuPathe, the migraine drug significantly reduced migraine symptoms like pain, nausea, and sensitivity to sound in a “statistically significant” number of the trial’s 530 participants in just two hours. Zelrix was well tolerated, with “mild and transient” adverse reactions like itching, tingling or pain.

In January of 2011, the FDA accepted a New Drug Application for Zelrix. NuPathe had hoped to receive approval for the migraine medicine in August, but instead, the FDA returned with a request for more information. While the regulatory body did not question the patch’s effectiveness, it raised questions about its chemistry, manufacturing and safety – presumably seeking assurance that the electronic migraine patch was delivering the correct dose and would not malfunction.

The electronic patch delivers a dose of a proven prescription migraine medication, sumatriptan (brand name Imitrex). GlaxoSmithKline won initial approval for Imitrex in 1993 as an injection, in 1995 as Imitrex tablets, and in 1997 as a nasal spray. GlaxoSmithKline’s patent has now expired, allowing other companies to manufacture cheaper generic sumatriptan.

While the migraine medication is effective, common sumatriptan side effects include weakness, flushing, and neck pain, chest pressure, and abnormal sensations like burning, tightness or numbness. The new transdermal delivery route is designed to circumvent some of these side effects by bypassing the gastrointestinal tract. The patch is primarily targeted at the “niche market” of migraine sufferers whose nausea is so severe that they can’t keep oral migraine medication down.

About 30 million American adults suffer from migraine. The excruciating pain of migraines is often accompanied by nausea, vomiting, and extreme sensitivity to sound and light. Many migraine sufferers are forced to seek refuge in a dark, quiet place until the migraine lets up. The average migraine lasts from 4 to 24 hours, but they can rage on for days.

The FDA request for more information is expected to slow down the approval of the new migraine patch by at least six months. Despite the CEO’s insistence that NuPathe could provide the requested information to the FDA “in a timely manner”, the biotech company’s stock values tumbled 50% almost instantly upon news of the setback.

“We continue to believe that our patch will address the symptoms of millions of patients who suffer from debilitating migraine headache pain and migraine-related nausea, “NuPathe CEO Jane Hollingsworth reassured investors, “We look forward to working with the FDA to bring this important product to market.”

Conventional medicine has always been found wanting in bringing complete relief from pain experienced during a migraine attack. People suffering from consistent migraine often experience nausea and higher sensitivity to loud noise and bright light. Canadian online pharmacy finds alternate treatment like acupuncture more effective in bringing relief from pain without side effects.

How Pain Originates
Body tissues including the skin contain receptors, which are specialized cells in the nervous system transmitting pain signals experienced through damage to the tissue, injury, or inflammation. Signals are then carried through an intricate system with the use of electrical and chemical neurons first to the spinal cord and then through the spinal cord via interneurons to the brain, which interprets the signals as pain.
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The following are ten of the more intriguing non-traditional migraine treatments available today, some tried and true and some a little more “out there”:

Acupuncture is an ancient Chinese therapy that involves inserting very fine needles into blocked “energy points” on the body to restore the natural flow of “chi”, or life energy. Studies indicate that acupuncture may stimulate the brain to release pain-reducing endorphins and other chemicals. (more…)

There is a growing body of medical evidence that severe, chronic migraines can be triggered by gluten in sensitive individuals. Studies in England, Italy Turkey and America have identified migraine headaches as an often-unrecognized symptom of gluten intolerance, also known as celiac disease. “Our results suggest that a significant proportion of patients with migraine may have celiac disease,” Italian researcher Dr. Maurizio Gabrielli wrote in The American Journal of Gastroenterology, “and that a gluten-free diet may lead to improvement in migraine in these patients.” (more…)

The World Health Organization ranks migraine headache as number 19 on the list of disabling diseases worldwide.  Migraine affects about 28 million Americans, 75% of them women. Not every sufferer experiences a migraine in the same way. Migraine can be divided into two major sub-types – migraine with aura, and migraine without aura.

About one third of migraine sufferers have a premonitory sensory experience known as an aura before the headache strikes. Migraine with aura, or classic migraine, involves visual disturbances like flashes of light or blurred or tunnel vision, unusual tastes or odors, or body symptoms like tingling, numbness, weakness or dizziness.  This aura indicates that a migraine is on its way, usually within ten minutes to half an hour. (more…)

What is an ocular migraine? It seems to depend on who you ask, although the consensus is that an ocular migraine involves some sort of temporary visual disturbance. Some people use the term to describe the typical visual disturbances that are part of a normal migraine aura. About one third of common migraine sufferers report sensory experiences known as an aura before their headache strikes – visual disturbances like flashes of light or blurred or tunnel vision, an unusual taste or odor, or a body symptom like tingling, numbness or dizziness.  This aura indicates that a migraine is on its way shortly. (more…)

Migraine treatment varies according to the severity and frequency of headaches, and the degree to which they interfere with normal functioning. A full blown migraine can leave the victim totally incapacitated, often suffering from nausea, vomiting and a hyper-sensitivity to light and sound along with throbbing head pain. Over the counter migraine medications are generally not considered strong enough to treat a severe migraine.

There are now over 100 medications used to treat or prevent migraines, including drugs which have traditionally been used for other conditions. Migraine pain medications fall into two main categories: preventative and abortive medications. (more…)

The pulsing pain of a migraine can be excruciating, and is often made even more unbearable by accompanying nausea and even vomiting.  The smallest movement can cause the pain to pound more fiercely, and everyday light, noise and odors compound the agony.

If you have prescription migraine pain medication, it’s important to take it at the first sign of a migraine.  If you are one of the 20 to 30 percent of migraine sufferers whose migraines are preceded by a cluster of symptoms called an aura, take your migraine medication as soon as the first symptoms appear.  Common aura phenomena include visual disturbances like seeing flashes of light or zig zag lines, cloudy vision or tunnel vision. A pre-migraine aura can also involve hearing, smelling or tasting things that aren’t there; lightheadedness, tingling or numbness in the face or extremities, and difficulty understanding or speaking. (more…)