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4 mg Dose of Injectable Imitrex Approved

Injectable Imitrex in 4 mg doses has been approved by the FDA. Until now it was only available in 6 mg doses.

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A Celebrity in Our Midst: Marcia Cross & Migraine

Desperate Housewives actor Marcia Cross is part of our club. A migraineur since she was a teenager, Ms. Cross has partnered with GlaxoSmithKline (maker of Topamax and Imitrex) to spread the word that migraine isn’t “just a headache.”

The headache movement is gaining momentum! Someday soon society — including health care providers — will understand the debility that headache disorders cause. They have to. We’ve got a celebrity from a massively popular TV show as our spokesperson.

Sharing the stories of non-famous headache sufferers is also important. GSK and iVillage are sponsoring the My-graine Story contest for patients to do just that. There are prizes for the top entries, including a trip to meet Marcia Cross. More important is that participants can release their stories for future use by GSK or iVillage, which will our experiences even more real to non-sufferers. Entries will be accepted until January 31.

A recent Seattle Times story takes a deeper look at what Ms. Cross has to say about her struggles. But I warn you that the article contains an inaccurate stereotype of migraineurs that may make you as angry as it does me.

“Of the more than 28 million Americans who suffer from migraines, three times more women than men are affected — and tightly wound, control-freak Bree would seem to be a ready candidate.”

Does this mean that three times as many women are more high-strung than men? Or that migraineurs are tightly wound control-freaks? The theory of the “migraine personality” has been studied for years, but isn’t widely accepted. My favorite headache resource, Migraine: The Complete Guide, published by the American Council for Headache Education debunks the myth:

“Researchers who have intensively studied the personality makeups of migraineurs have found no evidence of a ‘migraine personality.'”

“Some migraineurs who display these personality traits may have developed them as a reaction to their illness. They may feel a strong need to keep order around them because they never know when their lives will be disrupted by a migraine attack.”

“Some experts suggest that this myth may be perpetuated by physicians who resent the demands of patients who illnesses they can’t successfully treat.” (Page 21)

Finding links for this post, I learned that Ms. Cross recently completed her clinical training to earn a master’s degree in psychology. How cool is that?

[Correction: Ortho-McNeil, not GSK, makes Topamax]

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Triptans are Apple to Oranges

A study published in the July/August issue of Headache found strong support for trying a different triptan if the first brand you tried didn’t give you sufficient relief. Researchers recruited migraineurs who weren’t helped by Imitrex (sumatriptan), and gave them Axert (almotriptan) or a placebo to take at the onset of their next migraines. 47% of participants in the Axert group experienced pain relief at the two hour mark of the migraine, whereas 24% of the placebo group did.

The authors say that they weren’t surprised by the results because “migraine patients are not all the same, migraine headaches are not all the same and triptans are not all the same.” Triptans differ enough to have different side effects too. A real-life example is that Imitrex made my husband, who has migraines about 8 times a year, violently ill. When he finally got over his Imitrex induced aversion to triptans, he tried Axert, which didn’t make him nauseous.

Switching Triptans May Improve Migraine Response is the Reuters article published about the study. The journal article abstract is also available.

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OTC Triptans Possible in UK

The UK’s drug regulation agency is considering making Imigran (a.k.a. Imitrex) and Zomig available over the counter with a pharmacist’s supervision. I’m curious to learn if the decision will foretell the outcome of such an attempt with the US FDA.

By 2008, US patents will expire on more than $80 billion worth of so-called blockbuster drugs. When generics become available, name-brand drugs risk losing 80% of their market share. Drug companies need these drugs to continue generating revenue so they can continue R&D on the next round of blockbuster drugs. One of the strategies to retain market share is to make the drug available OTC.

Imigran’s UK patent expires in 2006, so it’s more than likely that GlaxoSmithKline is seeking OTC approval to keep some of their market share. Zomig’s patent isn’t about to expire, but until Relpax was released, it was the most prescribed triptan in the UK. If Imigran is available OTC and docs are prescribing Relpax more than any other triptan, AstraZeneca will have to fight to keep it’s name and market position strong.

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Generic Imitrex

Imagine getting a triptan without spending a small fortune every time you fill the prescription. The FDA has tentatively approved the manufacture and marketing of a generic version of Imitrex (sumatriptan).

According to the FDA, final approval for any drug is contingent upon the expiration of “market exclusivity” or patent terms or both. The medication also has to continue to comply with the the conditions and information that the FDA has already accepted. So, generic sumatriptan may be available on the market sometime after the patent expires in 2009.

Thanks to Teri Robert for telling me the patent’s expiration date.