December 28, 1992, marked a new era for Migraine sufferers with FDA approval of injectable Imitrex (sumatriptan). Imitrex was the first Migraine abortive triptan medication, a class of medications that many Migraineurs would come to call “miracle drugs.” Imitrex tablets were approved by the FDA in 1995. Since then, six more triptans have entered the market – Maxalt, Zomig, Amerge, Axert, Frova, and Relpax.
Although triptans are a marked improvement over previous treatment options, many Migraineurs have not been fully satisfied with their results. Some do not achieve full relief from triptans, and the recurrence of Migraines within 24 hours of the first dose has been common.
With the patents on sumatriptan nearing their expiration, both generics of the current forms – injections, tablets, and nasal spray – and other medications containing sumatriptan are now in development and testing. The results involving Trexima, one such medication that is a combination of sumatriptan and naproxen, have now been published.
“Recent research suggests that migraine is more complex than previously believed, consisting of multiple mechanisms that each contribute to migraine pain in different ways. These studies found that Trexima, which is the first migraine-specific product designed to treat both inflammation and vasodilation in a single tablet, provided superior efficacy compared to placebo and its individual components.”
-Lead author Jan Lewis Brandes, MD
Assistant clinical professor, Vanderbilt University School of Medicine
Director, Nashville Neuroscience Group.
Multiple mechanisms may be involved in generating the migraine symptom complex, and medications targeted at multiple mechanisms may offer advantages over medications targeted at a single mechanism.
To evaluate the effectiveness and safety of a fixed-dose tablet containing sumatriptan succinate and naproxen sodium (Trexima) compared to effectiveness and safety of each administered separately and placebo for the acute treatment of Migraine attacks.