PRODUCT MONOGRAPH IMITREX DF IMITREX ... - GlaxoSmithKline

Nasal SprayProper name:Chemical name:sumatriptan3-[2-(dimethylamino)ethyl]-N-methyl-1H-indole-5-methanesulphonamideMolecular formula : C 14 H 21 N 3 O 2 SMolecular mass: 295.4Structural formula:Physicochemical properties:Physical Characteristics: White to pale yellow powder with a melting point about176° C.Solubility:In water (4°C, 20°C) ≈ 1 mg/mLpka: pka 1 (3° amine group) = 9.63pka 2 (sulphonamide group) >12Partition Coefficient: log P = 1.06 (20° C)CLINICAL TRIALSMigraine:TabletsThe efficacy of IMITREX ® Tablets for the treatment of migraine was established in fourmulticentre, randomized, placebo-controlled studies. Patients enrolled and treated in thesestudies were primarily female (84%), Caucasian (98%) and with a mean age of 40 years(range of 18 to 65 years). Patients were instructed to treat a moderate to severe headache.In Study 2, up to three doses were permitted to treat a single attack within a 24-hourperiod, non-responders could take a second dose at two hours, while any recurrence ofmigraine could be treated with a third dose. Studies 1, 3 and 4 were designed to allow forthe treatment of up to three attacks.October 21, 2014Page 25 of 58