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Retired

Member
New drug for migraines
USA Today
November 5, 2008

Headaches distract. Migraines can debilitate. Nearly 30 million Americans suffer from the throbbing pain, costing employers about $13 billion a year from missed workdays and impaired work function, according to research reported in the Archives of Internal Medicine.

"You can be out for three days - lie there and not move, feel nauseous but not throw up - it's incapacitating," says Jeanne Safer, 61, of New York, a psychotherapist who has had regular migraines for about a decade.

But new treatments in the pipeline may help control the pain. Some "exciting" new drugs are coming into the headache field, says Alan Rapoport, a UCLA professor of neurology who has studied headaches for 35 years.

Scientists still haven't agreed on a single cause of migraines, although genetic and hormonal factors and some environmental triggers often play a part.

But wherever a migraine starts, whether with malfunctioning nerve cells deep in the brain stem or hyperexcited neurons in the cerebral cortex, it sets off something called the trigeminal nerve system, which carries sensory information from the face, head and meninges (membranes covering the brain and spinal cord) to the brain stem.

During a migraine, the trigeminal nerve releases a peptide called CGRP (calcitonin gene-related peptide), which causes dilation of blood vessels and increased pain signaling. A drug that would prevent the peptide from activating the neurons is in final trials - Merck's telcagepant. Its latest study showed about 55 percent of patients had marked pain relief, and 23 percent were pain-free after two hours, significantly better than placebo patients. Merck plans to apply for Food and Drug Administration approval for telcagepant next year. Other companies are starting trials on similar drugs.

Interest among migraine specialists stems from evidence that these drugs are at least as effective as triptans, the most commonly prescribed class of migraine drug, writes Stephen Silberstein in the October issue of The Lancet.

Triptans were considered a major breakthrough when they arrived about 15 years ago. But unlike triptans, the new drugs don't constrict vessels, so they may be safer for patients with high blood pressure, high cholesterol and a variety of vascular diseases.

The heart warnings on triptans make some patients nervous, including Safer. But because she has about 15 headaches a month, she's settled on taking her triptan, Maxalt, in addition to Botox injections every 2 months and, if the pain is unbearable and she has used up her medication, shots of lidocaine, an anesthetic. Patients who received Botox had fewer days with headaches compared with those who got dummy injections, according to two studies funded by drugmaker Allergan.

See The Path Of Pain illustrated in the four thumbnail pictures below. Click on each thumbnail for an enlarged view
 

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Hoss

Member
Interesting, Steve. Let us know when they hit the market. Currently I take Axert, which my neurologist says has the best side effect profile of the Triptans, but I notice it interacting with my psych. meds. in certain ways - nothing too dramatic. It would be nice to have a new type to try.
 

David Baxter PhD

Late Founder
The Lancet, Volume 376, Issue 9741, Pages 645 - 655, 21 August 2010
doi:10.1016/S0140-6736(10)60323-6 Cite or Link Using DOI
Published Online: 22 April 2010

New drugs in migraine treatment and prophylaxis: telcagepant and topiramate

Original Text
Prof Lars Edvinsson MD a, Mattias Linde MD b c d

Summary
Although the triptan drugs provide effective relief from migraine for many patients, a substantial number of affected individuals are unresponsive to these compounds, and such therapy can also lead to a range of adverse effects. Telcagepant represents a new class of antimigraine drug—the calcitonin gene-related peptide receptor blockers. This compound exerts its effects by blocking receptors for the calcitonin-gene-related peptide at several sites in the trigeminal and central nervous systems, resulting in pain relief. Telcagepant does not cause vasoconstriction, a major limitation in the use of triptans. Comparisons with triptans in clinical trials for acute treatment of migraine attacks revealed clinical effects similar to those of triptans but better than those of placebo. Telcagepant might provide hope for those who have a poor response to, or are unable to use, older drugs. In patients who need prophylaxis because of frequent attacks of migraine, topiramate is a first-line drug for migraine prevention in many countries; it is generally safe and reasonably well tolerated. Data suggest that topiramate could aid reversion of chronic migraine to episodic migraine.
 

Retired

Member
I notice it interacting with my psych. meds. in certain ways

what are the medications you take and what is the nature of the interaction?

There may be an indefinite delay in the development of telcagepant. From an unofficial and unconfirmed source:

Unfortunately in a Phase II clinical trial (where the experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety), elevation of some liver enzymes occurred, causing concern about the safety of Telcagepant. The Phase II trial was discontinued, and Merck is currently setting safety protocols for a study to investigate if there are safety issues when Telcagepant is used as an abortive medication
.Telcagepant for Migraine - April/2010 Update - Migraine
 

David Baxter PhD

Late Founder
Telcagepant - The Miracle Migraine Headache Relief - Why You Have Not Gotten It Yet?
Oct 25, 2010

If you are a migraine sufferer, searching for the miracle migraine headache relief, you are going to be ecstatic to hear this. There is a new medication that should give you the lasting relief that you have been so desperately looking for. The question is not if the drug exists, it is when it will become available to you. Discovered in 1984 by professor Lars Edvinson at the University Hospital in Lund, South Sweden, a peptide called CGRP has the potential to change many lives. Originally, this drug was going to be released this year, so why has this not happened yet?

In the past two years, marketing for Telcagepant began. Advertisements about this powerful new medication were posted on the internet and printed in magazine spreads. Why is everyone so excited about this drug when there are so many other migraine pills on the market today? Telcagepant offers the added promise of no side effects for its patients. However, with the continued delay in this product hitting the market, it is causing migraine patients to lose their hope for this "miracle drug".

In recent events, the American drug company Merck, who developed this medication, decided to stop the introduction of Telcagepant. Then it was quickly understood that it was actually the FDA, Food and Drug Administration, in the USA that did not want this drug approved. Another turn of events came when it was discovered that Merck themselves had actually stopped the pill being introduced on the market, and Merck also informed the FDA of their decision. So as a migraine sufferer, what are you possibly supposed to do now? Any hope, of this migraine headache relief, has been dashed, and many people now feel like they are back at square one.

Another bit of information came when it started being rumored that the medicine actually did contain side effects, in fact quite a few side effects. It has been suggested that the presence of these side effects combined with the potential damage to the liver is what has halted the release of the drug. Fatigue, dizziness, nausea, and dry mouth are the complaints that have been made.

Currently, Telcagepant should be released in autumn of 2011. Despite the numerous problems, for this new migraine headache relief, involving the side effects and possible liver problems, the FDA is allowing Merck one more year to get everything under control so that the drug can be safe for migraine patients. While there is still hope for migraine sufferers, one could question just how much longer patients will be able to hold out hope.
 
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