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美国食品和药品管理局（FDA）7月23日批准Tudorza Pressair（阿地溴铵吸入性粉剂）用于慢性阻塞性肺病（COPD）引起的支气管痉挛（肺气道变窄），包括慢性支气管炎和肺气肿的长期维持治疗。
慢阻肺是一种严重的导致呼吸困难的肺部疾病。美国国家心脏、肺和血液研究所（National Heart, Lung, and Blood Institute，NHLBI）指出，吸烟是慢性阻塞性肺病的主要原因。在美国慢阻肺是第四大死亡原因。 其症状包括胸闷、慢性咳嗽、痰多。
Tudorza Pressair带干粉吸入器，每天使用两次，是一种长效抗胆碱药，能帮助肺部大气道周围的肌肉放松，从而改善通气。
“慢阻肺是一种随着时间推移病情持续恶化的严重疾病” FDA药物评价和研究中心药品评价II室主任、医学博士、公共卫生学硕士Curtis Rosebraugh说， “有效的慢阻肺长期维持药物为数百万患者提供了另一个选择治疗方案”。
三个随机、安慰剂对照试验验证了Tudorza Pressair的安全性和有效性。入选这些试验的患者均在临床上被诊断患有COPD，年龄≥40岁，且有每天至少一包烟的10年吸烟史。
Tudorza Pressair可能会引起严重的不良反应，包括反常的支气管痉挛、眼压增高或加重（急性窄角青光眼）、尿潴留或潴留加重。Tudorza Pressair不应被用作急救药物治疗突发呼吸问题（急性支气管痉挛），并且不推荐未满18岁患者使用。报道的Tudorza Pressair最常见的副作用包括头痛、鼻咽炎和咳嗽。
Tudorza Pressair由总部位于圣路易斯森林实验室的子公司森林实验室制药公司分销。
适应证和用途
TUDORZA™ PRESSAIR™ (aclidinium溴化物吸入粉)适用于长期，伴随慢性阻塞性肺病(COPD)支气管痉挛的维持治疗，包括慢性支气管炎和肺气肿。
剂量和给药方法
TUDORZA PRESSAIR的推荐剂量是一次经口吸入400 μg，每天2次。
剂型和规格
吸入粉。TUDORZA PRESSAIR是一种呼吸驱动的多剂量干粉吸入器，每次驱动计量400 μg的aclidinium溴化物。每次驱动从嘴口输送375 μg的aclidinium溴化物。
禁忌证
无。
Generic Name and Formulations:
Aclidinium bromide 400mcg/actuation; dry powder for oral inhalation.
Company:
Forest Laboratories
Indications for TUDORZA PRESSAIR:
Long-term, maintenance treatment of bronchospasm associated with COPD, including chronic bronchitis and emphysema.
Adult Dose for TUDORZA PRESSAIR:
400mcg twice daily.
Children's Dose for TUDORZA PRESSAIR:
Not established.
Pharmacological Class:
Anticholinergic.
Warnings/Precautions:
Not for initial treatment of acute episodes of bronchospasm. Narrow-angle glaucoma. Urinary retention. Milk protein sensitivity. Labor & delivery. Pregnancy (Cat. C). Nursing mothers.
Interactions:
Avoid concomitant anticholinergic agents.
Adverse Reactions:
Headache, nasopharyngitis, cough; hypersensitivity reactions (discontinue if occurs), paradoxical bronchospasm possible.
Generic Availability:
NO
How Supplied:
Dry powder inhaler—60 doses
Almirall has launched COPD treatment Eklira in Denmark following approval from the European Commission.
Phase III trials demonstrated that Eklira (aclidinium) provides significant and sustained bronchodilation and symptom control from its first dose, where its benefits become evident within half an hour.
It also reduced moderate and severe exacerbations by around a third, performed better than placebo and improved known COPD symptoms such as shortness of breath, cough, wheezing, exacerbations and chest tightness.
“The launch of Eklira/Genuair in Denmark is the first step in the European roll out of this new therapeutic option for COPD. We also expect to make this medicine available to patients in the UK and Germany soon”, said Eduardo Sanchiz, chief executive at Almirall.
Regulators have already approved the drug in the US where it is marketed by Forest Laboratories under the brand name Tudorza/Pressair.
The World Health Organisation estimates 210 million people suffer with the condition worldwide. Encompassing chronic bronchitis and emphysema, COPD is usually caused by smoking and is predicted to be the third leading cause of death anywhere by 2020.
Almirall are launching Eklira into a competitive big pharma marketplace led by two blockbusters - Boehringer and Pfizer’s Spiriva and GSK’s Seretide/Advair.
The patent will soon expire for the latter, but GSK and partners Theravance have the promising Relovair waiting in the wings, which has just been submitted to US and European regulators. | 
