Trexima, a combination of sumatriptan (Imitrex) and naproxen sodium (found in Aleve and other NSAIDs), was expected to receive FDA approval last week. Requesting more safety data, the FDA has delayed approval of Trexima.
The concern is about one of the four tests of genotoxicity, which is toxicity to DNA. The requested data are available from a study that has already been conducted. The FDA will meet with Pozen and GSK soon to discuss additional requirements.
“Do you need a naproxen dose every time you need a triptan dose?” Headache specialist Christina Peterson weighed in on the Trexima discussion with that brilliant question.
As bad as it is to make money by ill-informing consumers, that’s nothing compared to the possibility of worsening patients’ headaches.
Dr. Peterson pointed out that “many [headache specialists] recommend combining them–as an initial dose at headache onset. The potential danger could lie in a second or further subsequent dose.” This danger comes from medication overuse headache (commonly referred to as rebound headache or MOH).
This is as it sounds: Taking too many painkillers (and some other drugs) can lead to more frequent headaches. These more frequent headaches lead to taking more painkillers. And the cycle goes on.
So, while taking naproxen with the first dose of Imitrex during a migraine can be helpful, taking it with further doses can lead to more harm in the long run. As Dr. Peterson says, it’s unlikely that insurance companies are going to be willing to pay for a prescription for Trexima and one for plain old Imitrex in the same month.
Here’s her full comment:
No. That question, which desperately needs to be answered, has not been answered. That head-to-head study has not been done. Why? Nobody stands to gain financially from the answer. Nobody except, of course, you and me–the consumers.
True–there is not likely to be any advantage of Trexima over taking an Imitrex plus an equivalent dose of naproxen sodium. There is no voodoo in the combination.
Could there be harm, though? This is why the FDA is taking so long to look at Trexima. I don’t think the concept of sumatriptan (or any other triptan) plus naproxen sodium is inherently dangerous. Many of us recommend combining them–as an initial dose at headache onset. The potential danger could lie in a second or further subsequent dose. Do you need a naproxen dose every time you need a triptan dose?
I have concerns that in the hands of doctors and patients who do not understand the intricacies of medication overuse headache–i.e., most–this combination product could result in an increased risk of excessive dosing in the frequent headache sufferer, possibly resulting in an increased number of headaches.
And I think we all know how slim the likelihood is that an insurance carrier will reimburse both a prescription of Trexima and plain Imitrex in a given month.
The new drug Trexima, a combination of Imitrex and Aleve (naproxen), “can provide faster, long-lasting relief of migraine pain than using either drug alone,” according to results of a study published in yesterday’s issue of the Journal of the American Medical Association.
In the study, Trexima relieved headaches within two hours in as many as 65% of participants, compared to 28% with the placebo. About 55% said Imitrex alone provided relief and as many as 44% said that naproxen did.
So it’s better than either drug alone, but is Trexima is more effective than taking Imitrex and naproxen at the same time? I’ve never seen this question answered. It’s a huge issue for patients because the Imitrex patent expires in 2009. Trexima extends profits from Imitrex because selling it in Trexima sales will cut into overall sales of Imitrex.
I get the arguments for using Trexima even if there’s no difference. Patients are more likely to take one medication than two. They also may have more faith in prescribed meds than over-the-counter drugs, which naproxen is. But would patients who can’t afford the brand-name drug be aware that they can get the same effect for much less money?
If Trexima is not more effective than taking Imitrex and naproxen in
separate pills, physicians assume responsibility for giving patients the
choice. At the very least, they should tell patients the different efficacy rates between the two. Some will for sure, but many others will follow the masses of drug rep cheerleaders.
GSK‘s foothold on the ethical side of the line is tenuous. I don’t begrudge a company earning money, but knowing the drug’s success rides on the pharmaceutical industry’s phenomenal marketing, patients will undoubtably lose.
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.
Help for Headaches has an in-depth post on Imitrex, including the drug’s history and the benefits of the new 4 mg injection. Teri puts my sparse post to shame!