0135, Fig. 2 —A). As shown in Figure 2 —B, within 1 hour after patch activation, a significantly higher percentage of patients in the sumatriptan TDS group were nausea-free compared with the placebo group (71% vs 58%, respectively; P = .0251). This significant difference was maintained for all subsequent time points up to and including 12 hours after patch activation (P ≤ .01).
Compared with placebo-treated patients, a significantly greater proportion of patients treated with sumatriptan TDS were photophobia- and phonophobia-free by 2 hours after patch activation (P ≤ .0028 for all comparisons), significant differences that were maintained for all subsequent time points up to and including 12 hours (P ≤ .0095). No treatment-emergent serious AEs were attributed to transdermal sumatriptan. Treatment-emergent AEs were reported by 50% of patients who received transdermal Selleckchem Venetoclax sumatriptan and 44% of patients who received placebo. As expected, most AEs with transdermal sumatriptan were application site reactions that resolved within 2 days (Table 2). Triptan sensation AEs were experienced by
1.7% of the subjects both for atypical sensations, and pain and pressure sensations vs 0% and 0.4% for placebo, respectively. A post-hoc analysis of the 215 patients who had nausea at baseline confirmed and extended these efficacy findings. At 1 and 2 hours post-activation, more patients with nausea achieved pain relief when treated with sumatriptan TDS than with
placebo (22% vs 13% at 1 hour and 54% vs 22% at 2 hours). Similarly, higher proportions Pifithrin-�� purchase were nausea-free at 1 and 2 hours after patch selleck products activation when treated with sumatriptan TDS compared with placebo (1 hour, 44% vs 32%, respectively; 2 hours, 68% vs 43%, respectively), as well as photophobia-free (1 hour, 31% vs 26%, respectively; 2 hours, 55% vs 34%, respectively) and phonophobia-free (1 hour, 42% vs 37%, respectively; 2 hours, 64% vs 37%, respectively). In this study, sumatriptan TDS provided rapid relief from migraine pain and associated symptoms, including nausea, suggesting that it may be an attractive alternative to oral formulations among migraineurs who delay or avoid taking oral migraine medications because of nausea. To assess the long-term tolerability and efficacy of sumatriptan TDS, 183 migraineurs who had participated in the randomized, double-blind, phase III study with sumatriptan TDS used sumatriptan TDS for acute treatment of migraine for up to 12 months in an open-label trial. The most common adverse events involved the patch application site (45% of patients). The only non-application site adverse events reported in >2% of patients were nausea (n = 6, 3.3%), upper respiratory tract infection (n = 6, 3.3%), and nasopharyngitis (n = 4, 2.2%). The incidence of triptan-associated adverse events was 1.6%.