Back in April the PAL fortune teller made some bold predictions about GlaxoSmithKline’s (NYSE:GSK) new migraine drug Treximet. (’GlaxoSmithKline sets out to dupe migraine sufferers with Treximet smoke and mirrors“). Treximet is nothing more than a combination of Imitrex (sumatriptan, soon to be available as a generic) and naproxen sodium (commonly known as Aleve and available over-the-counter). Treximet is a perfect example of what we called a Goober Grape drug, which we described thusly:

What’s a Goober Grape Drug?

Goober Grape, for the (fortunately) uninitiated, is a appalling combination of peanut butter and jelly in a single jar….

So henceforth, a “Goober Grape Drug” refers to any combination drug that offers no additional clinical advantage and only the most ridiculously minimal increase in patient convenience. There are certainly conditions in which combination pills are important, in that reducing the number of pills to be taken increases patient compliance, but allergies sure as heck ain’t one of ‘em.

Neither, for that matter, are migraines. There’s no evidence that taking Imitrex and naproxen in a single pill (as Treximet) is any more effective than taking it in two separate pills, which is not surprising. Given that migraines are often excruciating, it’s absurd to think that someone in the midst of a migraine would take one pill, but not two, to relieve their suffering.

So was the PAL Fortune Teller correct?
As the PAL fortune teller gazed into the Pharma Crystal Ball, a prediction was made that “TV ads will appear in prime time singing the praises of this “new” treatment for migraines. People frolicking through fields of flowers may or may not appear.” Anyone who watched the recent presidential debates saw the new Treximet commercial. In case you missed it see for yourself, here it is. (Note: there are not, in fact, people frolicking through fields of flowers)

Notice that the ad only says that Treximet is “superior to Imitrex tablets at relieving migraine pain” – it does NOT say that Treximet is superior to Imitrex and naproxen taken together.

The PAL fortune teller also predicted that:

“Yet you can be sure that Treximet’s price will be similar to what Imitrex costs right now ($25 a pill) and there’s a good chance it will be more expensive, as new drugs typically are ($30 a pill? More? Who knows?).”

We were wrong on this one — at least for now. On drugstore.com, 9 pills of Imitrex cost $199.98, and 9 pills of Treximet cost $229.78. That’s about $25 a pill for Imitrex and about $22 a pill for Treximet. Wait a minute, that means Imitrex is more expensive than Treximet (right now). What gives?

As we reported back in April, generic versions of Imitrex will become available starting in late 2008 and into 2009, when Imitrex’s patent will expire. So over the next year, the price of Imitrex will go down, finally settling most likely, as most generics do, at 20-30% of the brand-name’s price. We predicted that the cost of taking generic Imitrex and over-the-counter Aleve would eventually be about $7.50.

So GSK needs to do as much as they can to get people to switch to Treximet before generic Imitrex becomes available. That means running ads on TV, having drug sales people promoting Treximet to doctors, aggressively distributing samples to physicians’ offices. And another way to encourage doctors and patients switching is to price Treximet below the price of Imitrex.

What remains to be seen is what will happen once generic Imitrex becomes available. Inevitably there will be:

1. Imitrex patients who switch to Treximet before the generic becomes available who choose to stay on Treximet
2. New patients who start on Treximet without ever having taken Imitrex
3. Imitrex patients who switch to Treximet before the generic becomes available who then switch to generic Imitrex,
4. Imitrex patients who don’t switch to Treximet who then switch to generic Imitrex, many of them automatically. This is probably the scenario that GSK most wants to avoid. Most states, and most health plans, have policies requiring “mandatory generic substitution,” that is, if a generic is available for your drug, you’ll get the generic, unless your doctor writes “Dispense as Written” or “No Substitution” on the prescription.

Categories #1 & #2 above are those most likely to remain Treximet Loyalists. It’s distinctly possible that GSK will gradually increase the price of Treximet over time, after the generic becomes available. I’m willing to guess that a lot will depend on how successful they’re initial advertising and promotion is in manufacturing a market for Treximet. It’ll be interesting to observe.

So: We were right about the Treximet ads, and wrong (at least for now) about Treximet’s price. In the end, the PAL Fortune Teller is batting .500. Which is more than we at PAL can say right now for our beloved Red Sox, who are down 2-1 in the ALCS.

** Breaking News: To see updated information about the cost of Treximet, see our more recent post on this topic, from October 14, 2008: Was PAL right about GSK’s Goober Grape Drug, Treximet? Yes and No. **

GlaxoSmithKline (NYSE:GSK) sells a popular brand-name prescription drug for migraines, Imitrex. 2007 U.S. sales of Imitrex were $1.12 billion, making it a “blockbuster” in drug industry parlance. A single pill of Imitrex costs about $25.

Glaxo has certainly done its part over the years to preserve its market share on drugs with expiring patents and to prevent consumers from having access to more affordable generic versions, as alleged in several lawsuits that we here at PAL have been involved in (see Relafen and Augmentin, for example).

Well, $1.12 billion in annual sales is too good to just give up, right? Even if Imitrex’s patent is expiring next February? Not surprisingly, then, Glaxo has done a number of things to keep a generic version of Imitrex (sumatriptan) off the pharmacy shelves:

• Later this year, Glaxo will begin selling an “authorized generic” version of Imitrex. Authorized generics really should be called “fake” generics, because they’re most often not generics at all, but the company’s own pill technically sold by a different company, under a license. In this case, the shill licensee is Dr. Reddy’s, a generic drug company that originally challenged Glaxo’s Imitrex patent and then settled when Glaxo sued them for patent infringement.
• Also later this year (December 2008), Ranbaxy, another generic drug maker, will also begin selling a generic version of Imitrex. Again, this stems from a settlement between Glaxo and the generic maker.

Great, right? Two generic versions of Imitrex will be available by the end of the year! Huzzah! A victory for patients, right?

Not so fast! You don’t think Glaxo is going to let its billion dollar baby leave home so easily, do you?

Introducing GSK’s Treximet! Treximet was just approved by the FDA for acute treatment of migraines in adults.

Is Treximet a fabulous new breakthrough treatment for migraines?

Umm… No.

It is a combination of Imitrex (soon to be available as a generic) and naproxen sodium (commonly known as Aleve, available Over the Counter).

So Treximet is a combination of (a) a soon to be generic drug and (b) an Over the Counter drug. Yet you can be sure that Treximet’s price will be similar to what Imitrex costs right now ($25 a pill) and there’s a good chance it will be more expensive, as new drugs typically are ($30 a pill? More? Who knows?).

How much would it cost a patient to take these 2 drugs separately?

• Naproxen sodium can be had for about 8 cents a pill. A single Aleve pill has 220 mg of naproxen sodium. There’s 500 mg of naproxen sodium in Treximet, so a patient would have to take about 2 1/4 Aleve pills to get to 500 mg. Since you can’t really take 1/4 of a pill, let’s assume most patients would take 2. 2 pills would give you 440 mg, so that’s pretty close to the 500 mg. Cost: 16 cents.
• We don’t yet know how much generic Imitrex will cost. But the price of a generic typically drops to about 30% of the brand-name’s price within 6 months of the drug’s patent expiring and more generic companies introducing their own versions. So it’s safe to assume that generix Imitrex will cost about $7.50 by middle of 2009. (Even before then, the price of generic Imitrex will begin dropping from the current price of $25 a pill.) Cost: $7.50

So, by spending $7.50 on generic Imitrex and 16 cents on over-the-counter Aleve, you can get the same thing you’d get in a Treximet — which is very likely to cost $25 or more. Why would you bother with the Treximet? I guess it’s fewer pills to take, but is that worth at least $18 in additional cost?

Interesting, Glaxo apparent didn’t even try to compare Treximet to a standalone-combination of Imitrex and naproxen sodium. Their press release on the FDA approval says:

“Treximet provided more patients migraine pain relief at two and four hours compared to sumatriptan 85 mg, naproxen sodium 500 mg or placebo alone.”

In other words, Treximet worked better than just Imitrex, or just naproxen sodium, or nothing at all. This is kind of like saying that a chocolate cake tastes better than eating the ingredients separately (a bowl of flour, a few eggs, some chocolate) or eating nothing at all.

Here’s some other things I think you can safely gaze into the crystal ball to see:

• Glaxo’s pharmaceutical salespeople will descend on doctors’ offices like ants at a picnic and aggressively pitch Treximet to doctors of all kinds (neurologists, headache specialists, internists and family physicians).
• TV ads will appear in prime time singing the praises of this “new” treatment for migraines. People frolicking through fields of flowers may or may not appear.

Is this the kind of “breakthrough treatment” than PhRMA is always arguing justifies the high cost of prescription drugs?

This type of putting “old wine in new flasks” is straight from Big Pharma’s tired playbook. Instead of engaging in the harder, more long-term process of discovering genuinely new medications, drug companies instead “tweak” existing blockbuster drugs in the most minor of ways, including:

• Combining two existing drugs, such as was done with Vytorin (made up of Zocor, which had gone generic, and Zetia)
• Making a “extended release” version (once a day, once a month, etc)
• Making a “new” version that’s just a chemical tweak of the original but not any better (as Nexium is of the now-generic and over-the-counter Prilosec)

Conclusion: Migraine sufferers, don’t be suckered by Glaxo’s poorly-concealed bait and switch. And go read Consumer Reports Best Buy Drugs report on migraine medications.