一天一次的Azelastin鼻喷剂核准用于季节性过敏


  September 2, 2009 — 美国食品药物管理局(FDA)已经核准azelastine HCl 0.15%鼻喷剂(Astepro Once-Daily,Meda AB公司),用于治疗12岁以上季节性与常年性过敏性鼻炎患者。
  
  该产品包括比原来Astepro剂型更浓50%的药物,是第一个提供季节性过敏病患每天一次投予剂量的鼻喷剂抗组织胺。每个鼻孔喷两次,每天两次剂量,则适用于那些常年过敏患者。
  
  根据该公司的新闻稿,这个剂型被证实作用起始快速,可以在投药后30~45分钟内缓解症状。
  
  Irvine加州大学过敏与免疫学部门临床教授William Berger医师表示,Azelastine提供快速缓解,且可以直接作用于病灶部位,鼻管,来治疗许多鼻症状,包括因为室内或室外过敏原造成的鼻塞。根据鼻过敏症状的改善,azelastine 0.15%是受季节性与常年性过敏性鼻炎鼻症状所苦病患的第一线治疗。
  
  Azelastine 0.15%鼻喷剂的疗效在七项双盲、随机分派、安慰剂控制,为期二与四周的第三期临床研究中展现,在这些研究中,这个药物被用于改善整体鼻症状分数,包括流鼻水、鼻塞与鼻搔痒的分数。
  
  在这些短期研究中,每天一次与两次的Azelastine治疗,一般而言是耐受性良好的;比较常报告的不良反应包括苦味(分别为4%与6%)、鼻腔不适(分别为4%与3%)、流鼻血(分别为2%与1%)。低于1%的病患在接受药物治疗后发生嗜睡。
  
  在一项为期一年的安全性研究中,针对常年性过敏病患,与使用每天两次0.15% Azelastine鼻喷剂有关的不良反应,包括苦味、头痛、鼻窦炎与流鼻血。并没有观察到严重的流鼻血、鼻腔溃疡或是鼻中膈穿孔。
  
  0.1% Azelastine鼻喷剂过去被核准用于12岁以上季节性过敏鼻炎,每天使用两次。
  

Once-Daily Azelastine Nasal Spray Approved for Seasonal Allergies

By Yael Waknine
Medscape Medical News

September 2, 2009 — The US Food and Drug Administration has approved azelastine HCl 0.15% nasal spray (Astepro Once-Daily; Meda AB) for the treatment of seasonal and perennial allergic rhinitis in patients 12 years and older.

The product is 50% more concentrated than the original Astepro formulation and represents the first nasal antihistamine to offer once-daily dosing for patients with seasonal allergies. A twice-daily dose of 2 sprays per nostril is recommended for those with year-round allergies.

According to a company news release, the formulation has demonstrated a rapid onset of action, relieving symptoms within 30 to 45 minutes of dosing.

Azelastine provides fast-acting relief and is applied right at the site — in the nasal passage — to treat a broad spectrum of nasal symptoms, including congestion caused by indoor and outdoor allergies," said William Berger, MD, clinical professor in the Division of Allergy and Immunology at the University of California, in Irvine. "Based on demonstrated improvement in nasal allergy symptoms, [azelastine] 0.15% is a good first-line therapy option for seasonal and perennial allergic rhinitis patients suffering with nasal symptoms."

The efficacy of azelastine 0.15% nasal spray was demonstrated in 7 double-blind placebo-controlled 2- and 4-week phase?3 trials, in which its use significantly improved total nasal symptom score, a composite of rhinorrhea, nasal congestion, sneezing, and nasal itching scores.

Once- and twice-daily treatment with azelastine 0.15% nasal spray was generally well tolerated in these short-term studies; adverse events most commonly reported included bitter taste (4% and 6%, respectively), nasal discomfort (4% and 3%, respectively), epistaxis (2% and 1%, respectively), and sneezing (1% and 2%, respectively). Somnolence occurred in less than 1% of patients receiving active treatment.

In a 1-year long-term safety study of patients with perennial allergic rhinitis, adverse events associated with twice-daily use of azelastine 0.15% nasal spray included bitter taste, headache, sinusitis, and epistaxis. No severe epistaxis, nasal ulcerations, or septal perforations were observed.

Azelastine 0.1% nasal spray was previously approved for the twice-daily treatment of seasonal allergic rhinitis in patients 12 years and older.

    
相关报导
Azelastine加Fluticasone鼻喷剂可缓解过敏性鼻炎症状
2009/11/26 下午 03:55:00

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