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Teva哮喘新产品ProAir RespiClick获FDA批准

来源:生物谷 2015-04-02 21:27

2015年4月3日讯 /生物谷BIOON/ --以色列医药巨头Teva公司近日宣布其呼吸系统疾病新产品ProAir RespiClick获得了FDA批准,该产品是一种由呼吸驱动的干粉吸入器,内置了短效β受体激动剂(SABA)硫酸沙丁胺醇粉剂,用于12岁及以上哮喘患者,治疗和预防伴有可逆性阻塞性气道疾病的支气管痉挛,以及用于预防运动诱发性支气管痉挛。

“ProAir RespiClick是FDA批准用于治疗急性哮喘症状的首个也是唯一一个由呼吸驱动的干粉急救吸入器。对于急性哮喘发作的患者来言,简直是救命稻草!”美国辛辛那提大学医学院的免疫学、过敏和风湿疾病专家David I. Bernstein如此评价Teva的新药。“ProAir RespiClick另一个优势是服药简单,只需轻轻一吸,而不像其他产品需要双手和呼吸协调起来。”

梯瓦预计,ProAir RespiClick最快三个月内能够与广大患者见面。

Teva组织了八组临床试验,受试者都是患有哮喘或运动中发生呼吸痉挛的年过12岁的的青少年或成人,结果证明其是安全有效的。不良事件与沙丁胺醇吸入剂类似。

最常见的不良反应发生在>1%的受试者中,主要是背部疼痛,身体疼痛,肚子疼,窦性头疼以及尿道感染。(生物谷Bioon.com)

英文原文:FDA Clears First Breath-Actuated Dry-Powder SABA Inhaler

The US Food and Drug Administration (FDA) has approved the short-acting beta-agonist (SABA) albuterol sulfate inhalation powder (ProAir RespiClick, Teva) for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for prevention of exercise-induced bronchospasm in patients aged 12 years or older, the company announced today.

"ProAir RespiClick is the first and only breath-actuated, dry-powder rescue inhaler to be approved by the FDA for the treatment of acute asthma symptoms," David I. Bernstein, MD, from the division of immunology, allergy and rheumatology, University of Cincinnati College of Medicine in Ohio, said in a company news release.

"The approval of ProAir RespiClick is significant as it eliminates the need for hand-breath coordination during inhalation," he added.

The company expects the product to become available during the next 3 months.

The safety and efficacy of ProAir RespiClick was demonstrated in eight clinical trials of adults and adolescents (aged 12 years or older) with asthma and exercise-induced bronchospasm, the company notes. Adverse events were consistent with those seen with previous albuterol inhalers.

The most common adverse events seen in > 1% of patients treated with ProAir RespiClick compared with placebo were back pain, body aches and pains, upset stomach, sinus headache, and urinary tract infection.

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