PRODUCT MONOGRAPH IMITREX DF IMITREX ... - GlaxoSmithKline

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Headache relief at two hours was statistically significantly greater for all sumatriptangroups when compared to placebo (see Table 6).Table 6Percentage of Patients with Headache Relief (0/1) 1 at 2 Hours Post OralDose for the Treatment of MigraineStudy Placebo (%) 25 mg (%) 50 mg (%) 100 mg (%)Study 1 27(n=212)Study 2 19(n=84)- - 67*(n=313)- - 50*(n=149)Study 3 23(n=154)- 49(n=331)-Study 4 28(n=98)47**(n=303)61*(n=302)61*(n=298)1 Headache relief is defined as a reduction in headache severity from grade 3 or 2 (severe or moderate) to grade 1 or 0(mild or no pain).- = Not evaluated*p
Table 7Percentage of Patients with Headache Relief (grade 0/1) 1 at 1- and 2- HoursPost Subcutaneous Injection for the Treatment of MigraineStudy 11-hour2-hourStudy 21-hour2-hourStudy 31-hour2-hourStudy Placebo †(%)2421(n = 62)1831(n=190)6 mg‡(%)73*70*(n=30)70*81*(n=384)2670*3982*(n=180)(n=350)1 Headache relief is defined as a reduction in headache severity from grade 3 or 2 (severe or moderate) to grade 1 or 0(mild or no pain)*.* p < 0.05 versus placebo.† Includes patients that may have received an additional placebo injection 1 hour after the initial injection.‡ Includes patients that may have received an additional 6 mg of IMITREX ® Injection 1 hour after the initial injection.For patients with migraine-associated nausea, photophobia and/or phonophobia atbaseline, there was a decreased incidence of these symptoms following administration ofIMITREX ® Injection compared to placebo.Nasal SprayThe efficacy of IMITREX ® Nasal Spray was conducted in seven controlled clinicalmigraine studies, in a total of 3693 patients. Patients were instructed to treat a moderateor severe migraine attack with a single dose of study medication.Those who experienced relief at 2 hours and received no rescue medication were allowedto administer a second identical dose within 2 and 24 hours, if significant worsening ofmigraine occurred. In all studies, patients treated a single attack except in Study 5 wherepatients were allowed to treat as many as three attacks.The clinical trials revealed the following incidence of headache relief, defined as adecrease in migraine severity from severe or moderate to mild or no pain, within 2 hoursafter treatment with intranasal sumatriptan at doses of 5, 10 or 20 mg (see Table 8 below).October 21, 2014Page 27 of 58
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PRODUCT MONOGRAPH IMITREX DF IMITREX ... - GlaxoSmithKline

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