naproxen sodium

15 May 2008

Treximet (formerly Trexima)

The drug now known as Treximet has been approved for sale in the USA (on the 15th of April, 2008). It’s expected to hit the shelves any time now, as a prescription medicine.

But what is Treximet (formerly Trexima)? And is it worth all the hype?

Actually, I’ve written about Treximet several times before (here for example) – it’s been in the testing phase for a long time. It’s a combination drug – containing sumatriptan succinate (Imitrex) and naproxen sodium (Aleve). You can expect to see more drugs like this in the future, as Triptans such as sumatriptan go generic and companies look for new things to sell.

With the approval, I thought it would be a good time to summarize the good and the bad about this much talked about drug.

First, the good. Tests have shown that it seems to work well. Tests were done on a mostly female Caucasian group with migraine. Results? Noticeable relief from pain both short term (after 2 hours) and longer term (up to 24 hours). And better relief than from either key ingredient alone, or a placebo. In the end, Treximet seems to work a little faster and better than either drug alone. Trexima uses something called RT Technology, which gets the ingredients into action in your body quickly.

The other benefit is that it also seems to help with nausea, and sensitivity to light and sound.

Sounds great, right? Well, there are a few concerns about Treximet. Most of these come from the fact that it’s a combination drug.

For example, sharp readers will notice that Treximet was compared to sumatriptan succinate and naproxen sodium in the clinic trials – each by itself, but not in combination. With the expected price of the pills, we have a right to ask – is Treximet really that much better than just taking sumatriptan succinate and naproxen sodium together? With the changes over the next few months, it looks like that option would be far cheaper.

Speaking of cost, will insurance companies be willing to cover Trexima prescriptions?

Another good question – do you need Trexima every time you feel you need to take an abortive medication? In other words, might you want the sumatriptan alone sometimes, and would your doctor and insurance company allow you to have both? And if you take Treximet in the first dose, do you need the combination again for the second dose? (Good discussion on that here)

Being a combination drug, you do get the potential for side effects from both ingredients – for example, increased risk of stroke and gastrointestinal problems (from the naproxen sodium – typical for this type of drug).

So, might Treximet help you? Yes. But proceed with caution to avoid both over-paying and over-drugging. Keep informed on this discussion. And feel free to join in with your comments.

16 April 2007

Trexima (and the problem with a double-drug)

James Medications, News 0

You might have heard about Pozen’s migraine product, Trexima, which is currently under review in the USA. I know I’ve heard about it – a lot about it. I’ve written about Trexima before, more than once.

Trexima is a combination drug. Its key ingredients are sumatriptan succinate (otherwise known as Imitrex) and naproxen sodium. Both of these have been a lot of help to migraine patients. But the amazing combo seems to do the job better than either of these individual drugs. And Trexima is more than just a combo. It uses RT Technology, which is supposed to get it into your system faster, a key aspect for migraineurs. Read more on Trexima here.

But there are problems with the two-drug approach. Headache specialist Dr Christina Peterson asks,"Do you need a naproxen dose every time you need a triptan dose?" Of course, the answer is most often no, and that raises a lot of questions. There are mild questions like, am I spending more than I need to? But there are more serious questions as well.

For example, will your doctor actually prescribe Trexima and another drug, such as Imitrex, in the same month? Would your insurance cover that?

But the worst questions have to do with simply taking more drugs than you need to, which could lead to rebound headache, actually making your symptoms worse.

This is a great discussion, and it brings up issues related not just to Trexima but many other drugs. And there are likely to be more drugs like Trexima showing up at the drugstore in the years ahead. Thanks to The Daily Headache for writing on this issue and continuing an important conversation. I recommend you read the post on Trexima and rebound there as well.

In the USA, the FDA review may come to a conclusion in August, meaning Trexima still may be available later this year.

1 December 2005

MT 100 coming to the UK

James Medications, News 0

MT 100, an oral migraine drug from Pozen, was been approved in the UK on Monday (28 Nov). The drug contains naproxen sodium and metoclopramide. Naproxen sodium is familiar to migraineurs, it reduces pain and inflammation, and is often used for migraine brought on by hormonal changes. Metoclopramide has been used to reduce pain and decrease nausea (it’s worked well for children with migraine). It also enhances the effect of naproxen sodium by accelerating it’s absorption.

Pozen gave up on MT 100 in the USA when the FDA expressed concerns that it may cause tardive dyskinesia, a rare disorder of the nervous system. Pozen argues that the drug is meant to be used intermittently, so the danger is minimal.

Pozen will be looking for distributors for the UK and various other countries.

6 August 2005

One new drug set aside, another on the way…

James Medications, News 1

Pozen, Inc. has decided to stop developing its new migraine drug, MT 100. The Naproxen Sodium and Metoclopramide Hydrochloride drug needed more trials, the FDA concluded. There have been concerns that it may cause tardive dyskinesia, a chronic disorder of the nervous system causing jerky movements in the face, tongue, and other parts of the body.

However, yesterday Pozen announced it was going to focus on another new drug, Trexima. Trexima is a combination of sumatriptan (formulated with "RT Technology") and naproxen sodium. So far the trials are going well, and Pozen is hoping to make the drug available as soon as possible. The ingredient in MT 100 that was causing concern, metoclopramide, is not present in Trexima. Sumatriptan and naproxen sodium are familiar to migraineurs. RT technology has been used with Imitrex – it allows the drug to dissolve very quickly after swallowing, getting it into the body where it’s needed much faster.