by Teri Robert, MyMigraineConnection Lead Expert
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.
How the study was conducted
Patients at 118 United States clinical centers who had been diagnosed with Migraine were randomly assigned to treatment and placebo groups for two studies. Study 1 included 1,461 participants; study 2 included 1,495. In both studies, patients were randomly assigned to one of four groups to receive different treatments at the onset of a Migraine:
- a single tablet containing sumatriptan, 85 mg, and naproxen sodium, 500 mg
- sumatriptan, 85 mg
- naproxen sodium, 500 mg
Results measured at two hours after dosing showed the combination of sumatriptan and naproxen sodium more effective than placebo for relief of pain, photophobia, phonophobia, and nausea. For 2- to 24-hour sustained pain-free response, the combination was more effective than either sumatriptan or naproxen sodium alone.
“Sumatriptan, 85 mg, plus naproxen sodium, 500 mg, as a single tablet for acute treatment of Migraine resulted in more favorable clinical benefits compared with either monotherapy, with an acceptable and well-tolerated adverse effect profile.”
Although these studies tested a specific medication, Trexima, the more important issue of the studies is that they addressed multiple mechanisms generating Migraine symptoms and looked at treating them with a combination of a triptan and an NSAID as opposed to either of them alone. Some doctors have been recommending that their patients take an NSAID along with their triptans. Certainly, these studies confirm this sound recommendation. Dr. Jan Lewis Brandes commented that Trexima may be a good option especially for general practice physicians (as opposed to headache and Migraine specialists) trying to find effective treatment for their patients.
As the expiration of the patent on Imitrex draws closer, we can expect to see new sumatriptan medications developed to be released once the Imitrex patent expires. Trexima is under development from GlaxoSmithKline and Pozen. Since Imitrex was originally developed by GlaxoSmithKline, it can be developed and released before the Imitrex patent expires. Trexima has been submitted to the FDA for approval. The FDA is reviewing trial data now, and Trexima will probably be approved and released by the end of 2007.
Brandes, Jan Lewis, MD; Kudrow, David, MD; Stark, Stuart R., MD; O’Carroll, C. Phillip, MD; Adelman, James U., MD; O’Donnell, Francis J., DO; Alexander, W. James, MD, MPH; Spurill, Susan E., MS; Barrett, Pamela S, PharmD; Lener, Shelly E., PharmD. “Sumatriptan-Naproxen for Acute Treatment of Migraine.” JAMA. 2007;297:1443-1454.
Interview: lead author Jan Lewis Brandes, MD; assistant clinical professor, Vanderbilt University School of Medicine; director, Nashville Neuroscience Group. April 3, 2007.
Press Release. “Trexmia (Sumatriptan/Naproxen Sodium) Superior Efficacy Data Published in JAMA.” Pozen and GlaxoSmithKline. April 3, 2007.
Teri Robert is a leading patient educator and advocate and the author of Living Well with Migraine Disease and Headaches. A co-founder of the Alliance for Headache Disorders Advocacy and the American Headache and Migraine Association, she received the National Headache Foundation’s Patient Partners Award and a Distinguished Service Award from the American Headache Society. Teri can be found on her website, and blog, Facebook, Twitter, StumbleUpon, Pinterest, LinkedIn, and Google+.