Trexima

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 August 2006

Trexima – sooner rather than later?

James Medications, News 0

time
There is a lot of hope that the drug Trexima will provide a treatment that is unique to everything else on the market. In spite of the fact that it is really a combination of drugs already available, it looks like the combination and delivery that Trexima has makes it greater than the sum of its parts. As Trexima proves itself, it’s likely other similar drugs will become available afterwards. But Pozen, Inc has been having a terrible time actually getting it on the market.

Just when it looked ready for release, the American FDA said they weren’t satisfied with the safety information. So now what? More trials? More changes? These things can take years.

Well, it looks like it may be sooner rather than later. Yesterday Pozen announced that it would provide the needed information by the end of the year. This seems to indicate that more trials aren’t needed, just an organization of the data that is already available. If all goes well, the drug may yet be available before the end of 2007. Here’s hoping they can get everything worked out. But it’s probably worth it to check out other options in the mean time – not many of us will be holding out breath.

10 June 2006

Trexima in the quagmire

James Medications 0

Yes, the new drug Trexima was supposed to be out sometime soon. But the FDA (in the USA) wants more information about just how safe the drug is, and that could mean more studies and trials and tests. If that’s really the case, we might not see it for months – even years.

Pozan, the makers of Trexima along with GlaxoSmithKline, were originally working on a drug called MT 100, when the FDA asked for more safety trials. Rather than taking the time, Pozen changed its focus to Trexima, and things were looking pretty positive until the FDA’s announcement on Friday. This was not good for Pozen’s shares, and not good for migraineurs who were hoping for great things in Trexima. As I said back in February, there’s nothing else quite like it out there, even though it contains drugs already available.

11 February 2006

Trexima – new drug coming soon

James Medications, News 0

There’s a new migraine drug that will probably appear on the market in the next few months, currently called Trexima. In October, the FDA accepted the drug from GlaxoSmithKline and POZEN Inc. for review.

Strictly speaking, it’s not 100% new – it’s actually a combination of two drugs that are already on the market. The first is sumatriptan succinate, commonly sold as Imitrex and Imigran. This is of course one of the Triptan class of drugs, used for migraine and cluster. Triptans bind certain serotonin receptors, and counteract inflammation.

The other is naproxen sodium, a nonsteroidal anti-inflammatory drug (NSAID), commonly sold as Aleve. Naproxen sodium works well to reduce pain and inflammation.

So why would you care if you’ve seen these drugs before? First, according to Dr Seymour Diamond (founder of the Diamond Headache Clinic), Trexima tends to work a little faster and also better than either drug alone. It also uses RT Technology, a new method for getting the drug into your system quickly. Robin Gaitens, a spokesperson for GlaxoSmithKline said that Trexima "demonstrated superiority over the individual components" and helped with common symptoms of migraine such as nausea and light/sound sensitivity. Clinical trials demonstrated that at the two hour point Trexima was more effective that either of the other drugs it’s made up of.

Gaitens is optimistic about the drug because it attacks multiple mechanisms that are involved in a migraine attack. There’s really nothing else quite like it currently available.

Watch for more drugs like this to start coming down the pipeline. Sumatriptan is a logical place to start in a combination drug of this sort, but there are many other types of triptans now that may work better in the end.