A study published in the July/August issue of Headache found strong support for trying a different triptan if the first brand you tried didn’t give you sufficient relief. Researchers recruited migraineurs who weren’t helped by Imitrex (sumatriptan), and gave them Axert (almotriptan) or a placebo to take at the onset of their next migraines. 47% of participants in the Axert group experienced pain relief at the two hour mark of the migraine, whereas 24% of the placebo group did.
The authors say that they weren’t surprised by the results because “migraine patients are not all the same, migraine headaches are not all the same and triptans are not all the same.” Triptans differ enough to have different side effects too. A real-life example is that Imitrex made my husband, who has migraines about 8 times a year, violently ill. When he finally got over his Imitrex induced aversion to triptans, he tried Axert, which didn’t make him nauseous.
Switching Triptans May Improve Migraine Response is the Reuters article published about the study. The journal article abstract is also available.
The UK’s drug regulation agency is considering making Imigran (a.k.a. Imitrex) and Zomig available over the counter with a pharmacist’s supervision. I’m curious to learn if the decision will foretell the outcome of such an attempt with the US FDA.
By 2008, US patents will expire on more than $80 billion worth of so-called blockbuster drugs. When generics become available, name-brand drugs risk losing 80% of their market share. Drug companies need these drugs to continue generating revenue so they can continue R&D on the next round of blockbuster drugs. One of the strategies to retain market share is to make the drug available OTC.
Imigran’s UK patent expires in 2006, so it’s more than likely that GlaxoSmithKline is seeking OTC approval to keep some of their market share. Zomig’s patent isn’t about to expire, but until Relpax was released, it was the most prescribed triptan in the UK. If Imigran is available OTC and docs are prescribing Relpax more than any other triptan, AstraZeneca will have to fight to keep it’s name and market position strong.
Imagine getting a triptan without spending a small fortune every time you fill the prescription. The FDA has tentatively approved the manufacture and marketing of a generic version of Imitrex (sumatriptan).
According to the FDA, final approval for any drug is contingent upon the expiration of “market exclusivity” or patent terms or both. The medication also has to continue to comply with the the conditions and information that the FDA has already accepted. So, generic sumatriptan may be available on the market sometime after the patent expires in 2009.
Thanks to Teri Robert for telling me the patent’s expiration date.