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FDA Delays Approval for Migraine Drug Trexima

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.

Related posts:

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Rebound Headaches a Risk With Trexima

“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.

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Trexima Aborts Migraines Better Than Imitrex or Aleve Alone

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.

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News, News, News

There is never enough time for me to post about all that I want to write about. And there’s been a ton of headache news lately. Here are some highlights.

Detailed Results of Trexima Studies (the drug isn’t named in the study, but it looks like Trexima to me)

  • Neck pain and discomfort decreased significantly at two hours for the compound versus placebo in study 1 (35 and 44 percent) and study 2 (28 and 54 percent).
  • Sinus pain and pressure decreased significantly at two hours for the compound versus placebo in study 1 (19 and 33 percent) and study 2 (23 and 38 percent).(1)
  • More patients were pain free at two hours in both studies (52 and 51 percent) compared to placebo (17 and 15 percent) and sustained pain-free response was maintained for significantly more patients (45 and 40 percent), without the use of a rescue medication, to 24 hours, compared to placebo (12 and 14 percent).
  • The compound was effective in rapidly eliminating migraine pain, as measured by pain-free rates at 30 minutes, one hour, two hours and four hours.
  • Incidence of migraine associated symptoms (nausea, phonophobia (sensitivity to sound) and photophobia (sensitivity to light)) was lower with the compound than with placebo.
  • The compound was generally well-tolerated. In both studies, only nausea (3 and 4 percent) and dizziness (1 and 2 percent) were reported in at least 2 percent of patients who took the compound versus placebo (1 and 2 percent for nausea, 0 and < 1 percent for dizziness).

Confusion Over Safety Of NSAIDs For Pain Relief Leads Patients To Suffer In Silence
Almost two thirds of people surveyed (64%) said they were confused about what to take for pain relief because of conflicting information on drug safety that has emerged following the withdrawal of Vioxx (rofecoxib), a COX-2 selective non-steroidal anti-inflammatory drug (NSAID) . Around 4 out of 5 (78%) said they didn’t know enough about the risks and benefits of medicines, whether prescribed or bought over-the-counter. Almost half (47%) said they weren’t using any painkiller medication at all for a number of reasons. Some were concerned about side effects, often after reading worrying news stories about painkillers, some had been advised to stop medication by their PCP and some thought they could manage without them.

Triple Therapy Synergy for Frequent Severe Migraine (registration may be required to read this)
The combination of behavioral migraine management, preventive medication, and optimal acute therapy appears to provide a superior reduction in migraine activity measures, functioning, and quality of life compared with any one alone, according to a study presented at the American Headache Society meeting here.

For these patients, “effective migraine management may require three components: a tailored acute therapy, preventive medication and behavioral migraine management to get the optimal results,” said Kenneth Holroyd, Ph.D., a professor of health psychology at Ohio University in Athens, Ohio, in an oral presentation.

Overweight Kids More Likely to Get Headaches
Children with headaches are 36 percent more likely to be overweight, results of the new research suggest.

“The numbers tell us that being overweight may contribute to kids having more headaches, most often migraines,” said Andrew D. Hershey, M.D., Ph.D., director of the Headache Center and a pediatric neurologist at Cincinnati Children’s Hospital Medical Center. “There likely are a number of causes, including poorer general health, body stress, lack of exercise and nutrition. It may not be that being overweight directly causes migraine, but that the reasons for being overweight cause these children to have worsening headaches.”

Magnetic Device Short-Circuits Migraine Headaches, Suggests Early Research
A hairdryer-sized magnetic device held briefly to the back of the head may short-circuit migraines before the pain starts, suggests preliminary research being presented at the 48th Annual Scientific Meeting of the American Headache Society (AHS).

People With Near-Daily Migraine Headaches Get Relief From Anti-Seizure Drug
An anti-seizure medication “quiets the brain,” providing relief to people with near-daily migraine headaches, suggest results of a randomized, multi-center study being presented at the 48th Annual Scientific Meeting of the American Headache Society (AHS).

FDA OKs the Pain Drug Opana
The drug, called Opana, is an opioid pain reliever taken by mouth. It will come in an extended-release form, called Opana ER, and an immediate-release version, simply called Opana.

The drugs contain oxymorphone hydrochloride, which was previously only available by injection. Endo Pharmaceuticals plans to relaunch the drug’s injected version for hospital use under the new trade name.

If you know of an article that I missed, please add it to the comments. Thanks!

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Health News Review

The media are awash with neatly packaged stories about headache medications, surgeries and treatments. These stories purportedly keep patients and the public abreast of relevant headache and health news, but often leave more questions than they answer. The website Health News Review helps the public evaluate the claims of medical news stories by rating the stories on their accuracy, balance and completeness.

Each story is given a satisfactory or unsatisfactory mark in each of the following categories:

  • Novelty of treatment
  • Availability of treatment
  • Treatment options
  • Disease mongering
  • Quality of evidence
  • Quantifying treatment benefits
  • Treatment harms
  • Treatment costs
  • Sources of information
  • Reliance on press release

These marks are translated into percentage scores and then into star ratings, which appear with every story. A story on Trexima, the not-so-novel migraine med, has been rated on the site. The story received 0 of 5 stars, as it was unsatisfactory in each of the review categories.

Even more helpful the the stars, there is a specific explanation for every category that is marked unsatisfactory. In the Trexima story, the unsatisfactory rated is explained as:

“The story gives no quantitative evidence from trials on Trexima or other migraine medication delivery methods. There is anecdotal evidence from two people whose migraine pain decreased (but didn’t stop completely) with the combination drug. In a trial of 50 mg sumatriptan and 500mg of naproxen sodium there was greater pain-relief for acute migraines than either drug alone or placebo (Smith, T.R., A. Sunshine, et al. (2005). ‘Sumatriptan and naproxen sodium for the acute treatment of migraine.’ Headache 45(8): 983-91.)

I’m impressed by what I’ve seen so far — and not just because I agree with every point they make about Trexima. As often as modern medicine is presented as magical, this tool is a reminder that fairy godmothers don’t wear white coats and stethoscopes.