Imitrex Oral Clinical Pharmacology

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Imitrex Oral - Clinical Pharmacology [Sumatriptan]

Table 1. Percentage of Patients With Headache Response (No or Mild Pain) 2 and 4 Hours Following Treatment

Placebo
2 hr 4 hr

IMITREX
Tablets
25 mg
2 hr 4 hr

IMITREX
Tablets
50 mg
2 hr 4 hr

IMITREX
Tablets
100 mg
2 hr 4 hr

Study 1 27% 38% 52% * 67% * 61% ** 78% ** 62%* * 79% **
(n = 94) (n = 298) (n = 296) (n = 296)
Study 2 26% 38% 52% * 70% * 50% * 68% * 56% * 71% *
(n = 65) (n = 66) (n = 62) (n = 66)
Study 3 17% 19% 52% * 65% * 54% * 72% * 57% * 78% *
(n = 47) (n = 48) (n = 46) (n = 46) *
p< 0.05 in comparison with placebo. *
p< 0.05 in comparison with 25 mg.

The estimated probability of achieving an initial headache response over the 4 hours following treatment is depicted in Figure 1.

Figure 1. Estimated Probability of Achieving Initial Headache Response
Within 240 Minutes *

* The figure shows the probability over time of obtaining headache response (no or mild pain) following treatment with sumatriptan. The averages displayed are based on pooled data from the 3 clinical controlled trials providing evidence of efficacy. Kaplan-Meier plot with patients not achieving response and/ or taking rescue within 240 minutes censored to 240 minutes.

For patients with migraine-associated nausea, photophobia, and/ or phonophobia at baseline, there was a lower incidence of these symptoms at 2 hours (Study 1) and at 4 hours (Studies 1, 2, and 3) following administration of IMITREX Tablets compared to placebo. As early as 2 hours in Studies 2 and 3 or 4 hours in Study 1, through 24 hours following the initial dose of study treatment, patients were allowed to use additional treatment for pain relief in the form of a second dose of study treatment or other medication. The estimated probability of patients taking a second dose or other medication for migraine over the 24 hours following the initial dose of study treatment is summarized in Figure 2.