以色列医药巨头Teva公司2015年4月宣布，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。
ProAir® RespiClick (albuterol sulfate) Inhalation Powder is indicated in patients 12 years of age and older for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.
PROAIR RESPICLICK
Rx
Pharmacological Class:
Beta2 agonist.
Active Ingredient(s):
Albuterol sulfate 90mcg/inh; dry pwd for oral inhalation with a dose counter.
Company
Teva Pharmaceuticals
Indication(s):
Treatment or prevention of bronchospasm in patients ≥12 years of age with reversible obstructive airway disease. Prevention of exercise-induced bronchospasm in patients ≥12 years of age.
Pharmacology:
Albuterol sulfate activates beta2-adrenergic receptors on airway smooth muscle. Activation of beta2-adrenergic receptors leads to the activation of adenylcyclase and to an increase in the intracellular concentration of cyclic-3',5’-adenosine monophosphate (cyclic AMP). This increase in cyclic AMP is associated with the activation of protein kinase A, which in turn inhibits the phosphorylation of myosin and lowers intracellular ionic calcium concentrations, resulting in muscle relaxation.
Albuterol relaxes the smooth muscle of all airways, from the trachea to the terminal bronchioles. Increased cyclic AMP concentrations are also associated with the inhibition of release of mediators from mast cells in the airway.
Clinical Trials:
Two 12-week, randomized, double-blind, placebo-controlled studies of identical design (Study 1 and Study 2), compared ProAir RespiClick (n=153) to a matched placebo dry powder inhaler (n=163) in patients with asthma aged 12–76 years old at a dose of 180mcg albuterol 4 times daily.
Serial FEV1 measurements (as average of the mean changes from test-day baseline at Day 1 and Day 85) demonstrated that two inhalations of ProAir RespiClick produced significantly greater improvement in FEV1 AUC0–6hr over the pre-treatment value than placebo in Study 1. Consistent results were observed in Study 2.
In Study 1, 44 of 78 patients treated with ProAir RespiClick achieved a 15% increase in FEV1 within 30 minutes post-dose on Day 1. The median time to onset was 5.7 minutes, and median duration of effect as measured by a 15% increase was approximately 2 hours. Consistent results were observed in Study 2.
A randomized, single-dose, crossover study evaluated adult and adolescent patients (n=38) with exercise-induced bronchospasm (EIB). Study data showed that two inhalations of ProAir RespiClick taken 30 minutes before exercise prevented EIB for the hour following exercise (defined as the maintenance of FEV1 within 80% of post-dose, pre-exercise baseline values) in 97% (37/38) of patients versus 42% (16/38) of patients when they received placebo.
For more clinical trial data, see full labeling.
Legal Classification:
Rx
Adults:
2 inhalations every 4–6 hours; in some patients: 1 inhalation every 4 hours may suffice. Exercise-induced bronchospasm: 2 inhalations 15–30 minutes before exercise.
Children:
Not established.
Contraindication(s):
Severe hypersensitivity to milk proteins.
Warnings/Precautions:
Avoid excessive use. Sensitivity to sympathomimetics. Discontinue if paradoxical bronchospasm or cardiovascular effects occur. Cardiovascular disease (eg, coronary insufficiency, arrhythmias, hypertension). Diabetes. Hyperthyroidism. Seizure disorders. Reevaluate periodically. Elderly. Labor & delivery. Pregnancy (Category C). Nursing mothers: not recommended.
Interaction(s)
During or within 2 weeks of MAOIs or tricyclics (increased cardiovascular effects); consider alternative therapy. Oral sympathomimetics: not recommended. Antagonized by ß-blockers. Monitor digoxin. Caution with non-potassium sparing diuretics (eg, loop or thiazide); monitor.
Adverse Reaction(s)
Back pain, pain, gastroenteritis viral, sinus headache, urinary tract infection; hypokalemia, paradoxical bronchospasm, cardiovascular effects, immediate hypersensitivity reactions (eg, rash, urticaria, angioedema).
How Supplied:
Inhaler (w. dose counter)—0.65g (200 inh)
LAST UPDATED:
6/19/2015