ST LOUIS (MD Consult) - On June 3, 2009, Almirall announced that the US Food and Drug Administration has approved Axert (almotriptan) for the treatment of migraine in adolescents (aged 12-17 years). Axert, a selective serotonin receptor agonist, was approved for use in adults with migraine in 2001.

According to Almirall, the results from more than 42 clinical studies with almotriptan that involved more than 18,000 patients support the efficacy and safety of Axert. A recent study, published in Cephalalgia, demonstrated that early treatment with almotriptan significantly reduced the mean duration of a migraine attack in patients who took almotriptan when pain was still mild compared with patients who took the drug after pain had become moderate to severe. In addition, the results showed that a significant number of patients were pain-free at 2 hours (53% for patients with mild basal pain vs 37.5% for patients with moderate-to-severe basal pain).

圣路易斯(MD Consult)——2009年6月3日，Almirall公司宣布美国食品药品管理局(FDA)已经批准Axert(阿莫曲坦)治疗青少年(12~17岁)偏头痛。Axert是一种选择性5-羟色胺受体激动剂，曾经在2001年获得批准用于治疗成人偏头痛。

 

据Almirall公司声称，至少有42项阿莫曲坦相关的临床研究结果证实了Axert的安全性和有效性，纳入的总病例数逾18,000例。最近有一项研究(发表于《头痛》杂志)结果显示，与疼痛转为中重度后服用阿莫曲坦相比，轻度疼痛时服用该药进行早期治疗可显著缩短偏头痛发作的平均时程，而且2h时无疼痛的病例数也明显偏多(在基线时轻度疼痛的患者中与在基线时中重度疼痛的患者中分别占53%对37.5%)。

 

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