The efficacy of TREXIMET in providing relief from migraine was demonstrated in 2 randomized, double-blind, multicenter, parallel-group trials utilizing placebo and each individual active component of TREXIMET (sumatriptan and naproxen sodium) as comparison treatments. Patients enrolled in these 2 trials were predominately female (87%) and Caucasian (88%), with a mean age of 40 years (range 18 to 65 years). Patients were instructed to treat a migraine of moderate to severe pain with 1 tablet. No rescue medication was allowed within 2 hours postdose. Patients evaluated their headache pain 2 hours after taking 1 dose of study medication; headache relief was defined as a reduction in headache severity from moderate or severe pain to mild or no pain. Associated symptoms of nausea, photophobia, and phonophobia were also evaluated. Sustained pain free was defined as a reduction in headache severity from moderate or severe pain to no pain at 2 hours postdose without a return of mild, moderate, or severe pain and no use of rescue medication for 24 hours postdose. The results from the 2 controlled clinical trials are summarized in Table 1. In both trials, the percentage of patients achieving headache pain relief 2 hours after treatment was significantly greater among patients receiving TREXIMET (65% and 57%) compared with those who received placebo (28% and 29%).

Further, the percentage of patients who remained pain free without use of other medications through 24 hours postdose was significantly greater among patients receiving a single dose of TREXIMET (25% and 23%) compared with those who received placebo (8% and 7%) or either sumatriptan (16% and 14%) or naproxen sodium (10%) alone.

Note that comparisons of the performance of different drugs based upon results obtained in different clinical trials are never reliable. Because studies are generally conducted at different times, with different samples of patients, by different investigators, employing different criteria and/or different interpretations of the same criteria, under different conditions (dose, dosing regimen, etc.), quantitative estimates of treatment response and the timing of response may be expected to vary considerably from study to study.

The percentage of patients achieving initial headache pain relief within 2 hours following treatment with TREXIMET is shown in Figure 1.

Figure 1. Percentage of Patients With Initial Headache Pain Relief Within 2 Hours

Compared with placebo, there was a decreased incidence of photophobia, phonophobia, and nausea 2 hours after the administration of TREXIMET. The estimated probability of taking a rescue medication over the first 24 hours is shown in Figure 2.

Figure 2. Cumulative Percentage of Subjects Taking a Rescue Medication Over the 24 Hours Following the First Dosea

aPlot also includes patients who had no response to the initial dose. 

TREXIMET was more effective than placebo regardless of the presence of aura; duration of headache prior to treatment; gender, age, or weight of the patient; or concomitant use of oral contraceptives or common migraine prophylactic drugs (e.g., beta-blockers, anti-epileptic drugs, tricyclic antidepressants).