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Trexima Study Presented at AAN Meeting

Just when I was ready to concede that Trexima might provide a migraine treatment better than existing meds, I read the fine print.

The articles say that 57-65% of participants who took Trexima, which combines Imitrex with naproxen (a NSAID, a relative to Advil), reported pain relief after two hours. In comparison, 50-55% of participants who took Imitrex and 28-29% who took a placebo reported relief after two hours. After four hours the percentages rose to 72-78% for Trexima, 61-66% for Imitrex and 37% for the placebo.

The treatment that most accurately compares to Trexima is Imitrex taken simultaneously with naproxen. Why wasn’t this combination studied? My guess is that including this comparison wouldn’t show enough of a difference between the two treatments to justify the FDA approving Trexima as a new drug. Thus, not allowing GSK to continue holding the Imitrex patent.

11 Responses to Trexima Study Presented at AAN Meeting

  1. Daniel Newby says:

    Oh, the FDA would still have approved it. But a trial like that would have given people ideas about combining pills on their own, cutting into Trexima sales.

  2. katy says:

    Thus, not allowing GSK to continue holding the Imitrex patent.

    pretty much

  3. Diana says:

    I’ve been wondering all along why it wouldn’t make more sense to take Imitrex and Alleve together than to bother developing this new drug. Thanks for this information.

  4. Pam says:

    Combining drugs is interesting, isn’t it? I have been on Topamax for over a year – the dose my neuro prescribed quit being effective, my primary wanted him to up the dosage, he wouldn’t do it – they bicker back and forth. He prescribes more and more relpax and vicodin – which I am encouraged to take more and more of TOGETHER – I wind up upping the dosage of Topamax myself about a month ago. Worked wonders. Why can’t they listen to us? I do NOT enjoy narcotics. They make me EXTREMELY nervous! Now I’ve cut back on the narcotics (barely touch the vicodin) only use the relpax when I feel the “tickle” seems to me that should be the goal. Who knows.

  5. Matt says:

    Trexima extending the patent life of Imitrex is not accurate. Imitrex goes off patent in 2009 with or without Trexima on the market. If Glaxo were to attempt some type of orally disintigrating version like Maxalt-that would extend the patent life. Trexima has no bearing on Imitrex patent life. That’s well documented in the press.

  6. Bart says:

    I thought it was interesting to read the studies on Trexima in detail as I discovered their method for evaluation only included dosing Imitrex and naproxen together as two separate pills. Certainly, Trexima is not going to be cheaper than Imitrex, and since their study of efficacy is based soundly on taking these meds as two separate pills (this fact is even pointed out on Prozen’s website), with NO proven benefit in a single formulation, who is going to buy this when they could simply buy some Aleve to add to their Imitrex dose?

  7. z3 says:

    As mentioned by someone else, the study tested two separate drugs in combination as an equivalent. Testing the combination against the same combination would have been pointless. Looks like you misunderstood the trial and then drew invalid conclusions from that.

    ********
    The study used a sumatriptan/naproxen sodium combination against sumatriptan (Imitrex) alone and also against a placebo.

    Testing the combination in one pill against the combination in two pills is exactly the point. Trexima is simply sumatriptan and naproxen sodium in one pill. The question that I want answered is this: Is a single pill of the same drugs more effective than one pill of each drug taken at the same time?

    K

  8. Z Bud says:

    Everyone should look a little closer. Migraine is a unique disease state, that effects numerous body systems. Most people with headaches experience naseau, often due to decreased gastric motility. Try dropping an alleve into a static static stomache and see what happens. The point of this combo is the unique delivery system. Currently available products relly on surface errosion, where as the newer products do not, much like the fast disolving tylenol you see on TV. Check it out.

    ********
    You’re absolutely right. Not all migraneurs have gastric stasis, though. We’re all similar but aren’t the same. Trexima may be a great solution for some, but it’s not the cure-all it’s being hailed as.

    Kerrie

  9. munjal says:

    i have a one doubt about the TREXIMA…and it is can you guys give me the link of this drug’s PATENT………..? please

  10. Megan says:

    Munjal – I’m afraid I don’t have that link. But there is more recent news on Trexima here: http://www.thedailyheadache.com/2007/08/trexima-approva.html

    – Megan

  11. Kathy says:

    I just saw an ad for Trexima. I had heard a while back that this was coming out. Before that I had read about the Imitrex/Naproxen combination efficacy, so when I feel a migraine coming on I’ll take an Aleve first, sometimes that aborts it, if not I take an Imitrex.
    But what concerned me about Trexima was a potential side effect noted in the ad: “a rash that can be fatal and occur without warning”
    !!!!!
    I don’t remember that being a side effect of either on their own, I guess I’ll go back and read the labels again. But this combo now sounds very scary to me.

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