Moen Marit D, Keating Gillian M
Adis International Limited, 41 Centorian Drive, Mairangi Bay, Auckland 1311, New Zealand.
Drugs. 2006;66(6):883-90. doi: 10.2165/00003495-200666060-00018.
Sumatriptan is a serotonin 5-HT(1B/1D) receptor agonist that is used for the acute treatment of migraine attacks. A new fast-disintegrating/rapid-release sumatriptan tablet (sumatriptan FDT/RRT) has been developed with the goal of speeding absorption and onset of effect compared with standard sumatriptan tablets. Bioequivalence of sumatriptan FDT/RRT tablets to standard sumatriptan tablets was established in healthy volunteers. Initial data suggest that sumatriptan FDT/RRT tablets may disintegrate faster and get emptied from the stomach faster than standard sumatriptan tablets. In a randomised, double-blind, multicentre, early intervention trial in adults with mild migraine, significantly more sumatriptan FDT/RRT 50 and 100mg recipients than placebo recipients were pain free or migraine free 2 hours after receiving study medication. Compared with placebo, pain relief was significantly greater with sumatriptan FDT/RRT 100mg at 25 and 17 minutes following administration, and with sumatriptan FDT/RRT 50mg at 50 and 30 minutes following administration, in two randomised, double-blind, multicentre trials in adults with moderate to severe migraine. Sumatriptan FDT/RRT tablets were generally well tolerated; the tolerability profile was similar to that reported for standard sumatriptan tablets in other studies.
舒马曲坦是一种5-羟色胺5-HT(1B/1D)受体激动剂，用于偏头痛发作的急性治疗。已研发出一种新型速崩解/速释舒马曲坦片（舒马曲坦FDT/RRT），目的是与标准舒马曲坦片相比加快吸收并起效。在健康志愿者中确定了舒马曲坦FDT/RRT片与标准舒马曲坦片的生物等效性。初步数据表明，舒马曲坦FDT/RRT片可能比标准舒马曲坦片崩解更快且从胃中排空更快。在一项针对轻度偏头痛成人的随机、双盲、多中心、早期干预试验中，接受研究药物2小时后，接受50毫克和100毫克舒马曲坦FDT/RRT的受试者无痛或无偏头痛的比例显著高于接受安慰剂的受试者。在两项针对中度至重度偏头痛成人的随机、双盲、多中心试验中，与安慰剂相比，服用100毫克舒马曲坦FDT/RRT后25分钟和17分钟以及服用50毫克舒马曲坦FDT/RRT后50分钟和30分钟时的疼痛缓解程度显著更大。舒马曲坦FDT/RRT片总体耐受性良好；耐受性情况与其他研究中标准舒马曲坦片的报告相似。
