2014年7月13日，梯瓦药物DuoResp Spiromax获欧盟委员会(EC)批准，用于适合糖皮质激素和长效β2-肾上腺素受体激动剂组合疗法的慢性阻塞性肺病(COPD)和哮喘(asthma)患者的治疗。
DuoResp Spiromax(budesonide & formoterol fumarate dihydrate，布地奈德 福莫特罗富马酸盐二水合物)是一种新的多剂量干粉吸入剂，由布地奈德(budesonide)和福莫特罗(formoterol)组成。布地奈德是一种吸入性皮质类固醇(ICS)，用于治疗哮喘患者和COPD患者潜在的炎症;福莫特罗是一种速效和长效β2激动剂(LABA)，用于缓解哮喘患者和COPD患者的支气管收缩(bronchoconstriction )。Spiromax吸入器采用独特的呼吸驱动技术，能够递送一致剂量的药物。
DuoResp Spiromax的开发，旨在改善药物的易用性，并递送一致剂量的药物。由于吸入器技术的落后，许多哮喘和COPD患者存在治疗不足(under-treated)的情况，这导致了额外的就诊次数以及需要紧急护理等形式的不必要负担。
DuoResp Spiromax将进入吸入性皮质类固醇/长效β2激动剂(ICS/LABA)固定剂量组合吸入剂细分市场，在全球范围内，ICS/LABA药物销售额达139亿美元，欧洲市场销售额达44亿美元。

DuoResp Spiromax (formoterol/budesonide) has been launched for use in adults with asthma or chronic obstructive pulmonary disease (COPD), where use of an inhaled corticosteroid and a long-acting beta2 agonist is appropriate.
The breath-actuated dry powder inhaler is available in two strengths:
•160/4.5 (formoterol fumarate dihydrate 6 microgram, budesonide 200 microgram per dose) - equivalent to Symbicort 200/6 Turbohaler
•320/9 (formoterol fumarate dihydrate 12 microgram, budesonide 400 microgram per dose) - equivalent to Symbicort 400/12 Turbohaler.
In asthma, the 160/4.5 inhaler may be used both as regular maintenance treatment and as needed in response to symptoms. The 320/9 inhaler must be used with a separate reliever.
In COPD, both inhalers are indicated for symptomatic treatment in patients with a forced expiratory volume in one second (FEV1) <50% predicted normal and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.
The Spiromax device has a design similar to that of pressurised metered-dose inhalers. There are three steps to using the inhaler: open, breathe and close. No priming is required. Dose confirmation is provided by a 'click' sound, lactose taste and a dose indicator.

Name	DuoResp Spiromax
Agency product number	EMEA/H/C/002348
Active substance	budesonide / formoterol fumarate dihydrate
International non-proprietary name (INN) or common name	budesonide / formoterol
Therapeutic area	AsthmaPulmonary Disease, Chronic Obstructive
Anatomical therapeutic chemical (ATC) code	R03AK07

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