Trexima™ (sumatriptan/naproxen sodium) demonstrated efficacy across multiple migraine attacks

Patients who suffer from migraines frequently cite inconsistent effectiveness as a reason for their dissatisfaction with their medicine. New data from more than 1,100 patients show that the investigational migraine therapy Trexima, when taken early, produced pain-free results at two and four hours, as well as a sustained pain-free response 2-24 hours, across individual patients’ multiple migraine attacks, demonstrating the consistency in efficacy that patients desire. Furthermore, nearly one third of all patients were pain free at two hours. These findings were presented today at the 59th Annual Meeting of the American Academy of Neurology.

“The anticipation of the next attack can be quite stressful for patients,” said Richard Lipton, MD, Professor of Neurology, Epidemiology and Social Medicine, Albert Einstein College of Medicine in New York. “Patients want a treatment that works quickly and provides consistent relief for each attack. These data are significant because they show that Trexima produced consistent pain-free results across multiple attacks in the same patient.”

Trexima, the proposed brand name for a single tablet containing sumatriptan 85 mg formulated with RT Technology™ and naproxen sodium 500 mg, is currently under review by FDA for the acute treatment of migraines in adults.

About the studies

The data are from two identical multi-center, double-blind, placebo-controlled cross-over studies of adult migraine sufferers. The study incorporated an early intervention model in which patients were instructed to treat while migraine pain was mild and within one hour of onset. Patients were randomized to one of five groups and instructed to treat four migraine attacks. Most patients (80 percent) treated three of four attacks with Trexima and the remaining attack with placebo; the remaining patients treated all four attacks with Trexima.

In both studies, Trexima produced a consistent response from attack to attack experienced by individual study participants. In patients treating three attacks with Trexima, more than half of patients taking Trexima were pain free at two hours, more than three-quarters were pain-free at four hours, and about one-third achieved a sustained pain free response in at least two attacks; 29 percent were pain-free at two hours in all three attacks. Similar findings were reported among patients who treated all four attacks with Trexima.

As further evidence of the consistent response with Trexima, of patients who were pain-free at two and four hours during the first attack, more than seven in 10 were pain-free at two and four hours during the second attack.

In more than 1,100 patients treating more than 3,300 attacks, adverse events reported in at least 2 percent of patients within 72 hours of taking Trexima were nausea, dizziness, dry mouth, somnolence and fatigue.