Satsuma Pharmaceuticals, Inc.

萨摩制药公司

, a late-stage biopharmaceutical company dedicated to bringing novel treatments to people who suffer from migraine and other debilitating conditions, and its corporate parent,

，一家致力于为偏头痛和其他衰弱性疾病患者带来新疗法的晚期生物制药公司，及其母公司，

Shin Nippon Biomedical Laboratories, Ltd.

新日本生物医药实验室有限公司

Announced that the FDA has approved a 505(b)(2) New Drug Application (NDA) for Atzumi (dihydroergotamine (DHE)) nasal powder for the acute treatment of migraine with or without aura in adults. Atzumi was previously known as STS101.

宣布FDA已批准Atzumi（二氢麦角胺（DHE）鼻粉）的505(b)(2)新药申请（NDA），用于成人偏头痛（有或无先兆）的急性治疗。Atzumi之前被称为STS101。

Migraine is a neurological disorder that is thought to be the result of temporary changes in the chemicals, nerves and blood vessels in the brain, with symptoms that are often incapacitating. According to the American Migraine Foundation, approximately 40 million Americans live with migraine. It is the second leading cause of disability worldwide in terms of time lost to disability and most common cause of disability among young women..

偏头痛是一种神经系统疾病，被认为是大脑中化学物质、神经和血管暂时变化的结果，其症状往往令人虚弱。根据美国偏头痛基金会的数据，大约有4000万美国人患有偏头痛。它是全球因残疾损失时间的第二大原因，也是年轻女性中最常见的致残原因。

'The approval of Atzumi is a milestone to celebrate, providing a new option for the acute treatment of migraine combining long-proven benefits of DHE with a patient-friendly and easy-to-use delivery system developed based on SNBL's novel intranasal drug delivery platform technology,' said Dr. Ryoichi Nagata, President and CEO of Satsuma.

“阿珠米的获批是一个值得庆祝的里程碑，它为偏头痛的急性治疗提供了新选择，将DHE久经验证的益处与基于SNBL新型鼻腔给药平台技术开发的患者友好且易于使用的递送系统相结合，”萨茨马公司总裁兼首席执行官永田亮一博士表示。

'We believe that Atzumi will contribute to improving the quality of life of patients struggling for relief from these highly disabling problems.'.

“我们相信，Atzumi将有助于改善那些努力摆脱这些高度致残问题的患者的生活质量。”

'DHE plays a unique clinical role in the acute treatment of migraine, providing patients long lasting effects and the unique ability to provide benefit even when taken late in a migraine attack. The convenience of Atzumi, the only DHE nasal powder, will offer patients ease of use combined with the important known DHE clinical advantages', said Dr. Stewart J.

“DHE 在偏头痛的急性治疗中发挥了独特的临床作用，为患者提供持久的效果，并且即使在偏头痛发作后期使用也能带来益处。唯一的 DHE 鼻粉 Atzumi 的便捷性将为患者提供使用的便利性，同时兼具重要的已知 DHE 临床优势，”Stewart J. 博士说道。

Tepper, M.D., Vice President of the New England Institute for Neurology and Headache in Stamford, Connecticut..

特珀，医学博士，康涅狄格州斯坦福德新英格兰神经学与头痛研究所副总裁。

Condition:

条件：

Migraine/Headache

偏头痛/头痛

Type:

类型：

drug

药物