FDA批准泼尼松缓释片增加多种适应证

圣路易斯(MD  Consult)——2012年7月26日，Horizon制药公司宣布，美国食品药品管理局(FDA)已经批准Rayos(泼尼松)缓释片(1 mg、2 mg及5 mg)用于治疗类风湿性关节炎(RA)、风湿性多肌痛、银屑病关节炎、强直性脊柱炎、哮喘和慢性阻塞性肺病等多种疾病。FDA颁发此批准令的依据是将Rayos的药代动力学与速释泼尼松相衔接的数据以及2项在RA患者中开展的临床试验的数据。

这2项临床试验未在速释泼尼松的原有安全性问题之外新发现其他问题。与使用Rayos有关的最常见不良反应包括液体潴留、高血糖症、高血压、行为异常及情绪改变、食欲增加以及体重增加。

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ST LOUIS (MD Consult) - On July 26, 2012, Horizon Pharma announced that the US Food and Drug Administration (FDA) has approved Rayos (prednisone) delayed-release tablets (1 mg, 2 mg and 5 mg) to treat a broad range of diseases including rheumatoid arthritis (RA), polymyalgia rheumatica, psoriatic arthritis, ankylosing spondylitis, asthma, and chronic obstructive pulmonary disease. The FDA approval was supported by data bridging the pharmacokinetics of Rayos to immediate-release prednisone and data from 2 trials conducted in patients with RA.

The clinical trial experience did not raise any safety concerns beyond those already established for immediate-release prednisone. The most common adverse effects associated with the use of Rayos include water retention, hyperglycemia, hypertension, unusual behavior and mood changes, increased appetite, and weight gain.