ST LOUIS (MD Consult) - On September 2, 2009, Meda Pharmaceuticals announced that the US Food and Drug Administration (FDA) has approved antihistamine Astepro (azelastine HCl) nasal spray (0.15%) for the treatment of symptoms of seasonal and perennial allergic rhinitis (SAR and PAR). This new Astepro formulation, which is 50% more concentrated than original Astepro, allows for convenient once-daily dosing for patients with seasonal allergies.
The FDA approval of Astepro 0.15% nasal spray was granted primarily on the results of 7 double-blind, placebo-controlled, phase 3 clinical trials of 2 to 4 weeks duration, and a long-term, 12-month safety trial, conducted in more than 2,300 patients with SAR or PAR. In the SAR trials, patients were treated with 2 sprays per nostril of either Astepro nasal spray 0.15% or placebo, administered once or twice daily. In the PAR trial, patients were treated with 2 sprays per nostril of either Astepro nasal spray 0.15% or placebo, administered twice daily. Overall, results from the 2- to 4- week clinical trials showed that patients treated with Astepro experienced a significant reduction in total nasal symptom scores (TNSS) over the entire study period compared with placebo. (The TNSS consists of patient-rated scores of nasal congestion, nasal itching, rhinorrhea, and sneezing.) A rapid onset of nasal symptom relief–in as early as 30 minutes in one clinical trial and in 45 minutes in a second trial–was experienced by patients treated with Astepro.
Once-daily or twice-daily use of Astepro nasal spray 0.15% was generally well tolerated in the 7 clinical trials. The most common adverse events that occurred in study patients dosed with 2 sprays per nostril (once or twice daily, respectively) for SAR and PAR included bitter taste (4%, 6%), nasal discomfort (4%, 3%), epistaxis (2%, 1%), and sneezing (1%, 2%). Overall, <2% of patients discontinued treatment as a result of adverse reactions. Study withdrawal for adverse reactions was similar among the treatment groups.
In the long-term safety trial, 466 patients (aged ≥12 years) with PAR were given a dose of Astepro nasal spray 0.15% of 2 sprays per nostril twice daily, and 237 patients were treated with mometasone nasal spray at a dose of 2 sprays per nostril once daily. The most frequently reported adverse reactions (>5%) with Astepro were bitter taste, headache, sinusitis, and epistaxis. Focused nasal examinations were performed on study patients and no nasal ulcerations or septal perforations were observed.
In the United States, Astepro nasal spray 0.15% is supplied as a metered-dose solution for intranasal administration. The solution is formulated with sucralose, a noncaloric sweetener with an established safety profile. Each metered spray of Astepro delivers 205.5 μg of azelastine hydrochloride.
Astepro's manufacturer plans to have the product available in pharmacies in early October 2009.
圣路易斯(MD Consult)——Meda制药公司在2009年9月2日宣布：美国食品药品管理局(FDA)已经批准0.15%浓度的抗组胺药Astepro(盐酸氮卓斯汀)鼻喷剂用于季节性鼻炎(SAR)和常年性鼻炎(PAR)的症状治疗。该Astepro新剂型浓度比原剂型增加50%，每日1次，以方便季节性过敏性鼻炎患者服用。
美国FDA对0.15%浓度Astepro鼻喷剂的批准认证主要得到来自7项双盲、安慰剂对照、III期临床试验的数据支持。试验共纳入超过2,300例SAR和PAR患者，周期为2~4周不等，还包括一项长达12个月的药物安全性试验。在SAR 试验中，患者用0.15%浓度的Astepro鼻喷剂和安慰剂分别喷2次于左右鼻腔，每日1~2次。在PAR 试验中，患者用0.15%浓度的Astepro鼻喷剂和安慰剂分别喷2次于左右鼻腔，每日2次。总体而言，2~4周的临床试验结果表明，与安慰剂相比，患者喷用Astepro后其鼻部症状总评分(TNSS，即鼻漏、鼻充血、喷嚏和鼻痒4个症状评分总和)在整个研究期间显著下降。患者喷用Astepro后鼻部症状迅速缓解，其中一项临床试验中，患者的鼻部症状在30 min后缓解，还有一项的患者在45 min后缓解。
上述7项临床试验的受试者均能普遍耐受每日喷用1~2次0.15%浓度的Astepro鼻喷剂。SAR和PAR试验(分别为每日1次和2次，每次每鼻腔2喷)中最常发生的不良事件包括苦味(4%和6%)、鼻部不适(4%和3%)、鼻出血(2%和1%)以及喷嚏(1%和2%)。总计不到2%的患者因发生不良反应而停止治疗。因不良反应而退出试验的患者人数在各治疗组间相似。
在上述长期安全性试验中，466例年龄大于12岁的PAR患者每日喷2次0.15%浓度的Astepro鼻喷剂，每次每鼻腔2喷；237例患者每日喷1次莫米松(mometasone)鼻喷剂，每次每鼻腔2喷。Astepro鼻喷剂最常见的不良反应为苦味、头痛、鼻窦炎、鼻出血。对受试患者重点检查了鼻部情况，未发现鼻腔溃疡或鼻中隔穿孔。
0.15%浓度的Astepro喷鼻剂在美国采用定量溶液吸入的方式供患者使用。该溶液由无热量甜味剂三氯蔗糖按现行安全标准配置而成。每剂Astepro定量喷剂含205.5 μg盐酸氮卓斯汀。
生产商计划在2009年10月上旬允许Astepro在药店销售。
