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
- placebo
Study results
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.
Study conclusion
“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.”
Summary
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.
