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近日,爱尔兰药企Alkermes的抗抑郁药物ALKS 5461在一项关键Ⅲ期临床试验中获得成功。ALKS 5461是一种每天口服1次的试验性新药,可作为重度抑郁症(MDD)的辅助性治疗。这项名为FORWARD-5的积极临床顶线数据表明,与安慰剂相比,ALKS 5461能够明显改善患者的抑郁症状,具有统计学上的显著差异。此外,患者对该药物的耐受性普遍较好,常见的不良反应包括头晕、恶心和疲劳。根据FORWARD-5的安全性和有效性数据,Alkermes表示共计计划向FDA的精神类药物部门提交上市
Recently, ALKS 5461, an anti-depressant drug from Alkermes, an Irish pharmaceutical company, was successful in a pivotal Phase III clinical trial. ALKS 5461 is a test drug that is taken orally once daily as an adjunct to major depressive disorder (MDD). The positive clinical top-line data, called FORWARD-5, showed that ALKS 5461 significantly improved patients’ depressive symptoms compared with placebo, with statistically significant differences. In addition, patients are generally well tolerated by the drug and common adverse reactions include dizziness, nausea and fatigue. According to FORWARD-5’s safety and efficacy data, Alkermes said it plans to submit its listing to the FDA’s psychotropic drug department