FDA批准非处方贴剂Oxytrol治疗女性膀胱过动症

圣路易斯(MD Consult)——2013年1月25日，美国食品药品管理局(FDA)与默克宣布，女用型Oxytrol(奥昔布宁经皮给药系统，3.9 mg/d)已成为首个获准用于治疗年龄≥18岁女性的膀胱过动症(OAB)的非处方(OTC)药物。对于男性而言，Oxytrol仍将作为治疗OAB的处方药。奥昔布宁是一种抗胆碱能药物。

女用型Oxytrol作为OTC药物的安全性和有效性，已在总共纳入5,000多例患者的9项研究中得到了确认。总体而言，这些研究的结果显示，消费者能够理解药物标签上的信息，能够正确选择适合自己的产品并且合理使用。

在临床研究中报告的不良反应均较轻，包括使用贴剂处的皮肤刺激、口干和便秘。

根据默克的预期，女用型Oxytrol将在2013年秋季开始销售。

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ST LOUIS (MD Consult) - On January 25, 2013, the US Food and Drug Administration (FDA) and Merck announced the approval of Oxytrol for Women (oxybutynin transdermal system, 3.9 mg/d), the first over-the-counter (OTC) treatment for overactive bladder (OAB) in women aged 18 years and older. Oxytrol will remain available for men with OAB by prescription only. Oxybutynin is an anticholinergic.

Oxytrol for Women's safety and effectiveness for OTC use were established in studies of more than 5000 participants in 9 studies. Overall, results from these studies showed that consumers can understand the information on the label, properly select whether the product is right for them, and use the drug appropriately.

Adverse effects reported during clinical studies were mild and included skin irritation where the patch was applied, dry mouth, and constipation.

Merck anticipates that Oxytrol for Women will be available in fall 2013.

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