FDA批准透皮吸收贴片Oxytrol治疗女性膀胱过度兴奋症
2月26日，FDA宣布批准Watson制药公司开发研制的透皮吸收贴片Oxytrol用于治疗膀胱过度兴奋。
目前美国市场上治疗此类病症的常用药物有法玛西亚的Detrol LA及强生公司的Ditropan XL。与这些药物不同，由于Oxytrol是透过皮肤将药物传输入血的一种贴片，不需经过肝肠系统，因此可避免常用药物引起的不良反应如口干，便秘等。Oxytrol贴片含有的活性药物为奥昔布宁。可将它贴于腹部、髋部、臀部，用于缓解膀胱过度活动症相关的症状，效果可持续四天。
公司发言人称，计划在第二季度全面上市这种半透明的Oxytrol贴片。临床试验中Oxytrol常见的不良反应是对皮肤的刺激。Oxytrol不被推荐用于尿潴留，胃潴留，青光眼或对奥昔布宁过度敏感的患者使用。
透皮奥昔布宁配方Oxytrol的Ⅲ期试验结果阳性
Watson pharmaceutical公司的透皮奥普布宁配方，Oxytrol的第一个Ⅲ期试验资料显示，该药能显著地减少膀胱过度活跃的症状，且其抗胆碱能副作用并不多于安慰剂。
如获得批准，较少的抗胆碱能副作用如口干，可能使它优于奥昔布宁的口服制剂。这些创作用的严重程度常是病人耐受口服剂型的制约因素。Watson提出的抗胆碱能副作用减少是因为它不通过肝脏与胃肠道代谢，导致能引起这些副作用的代谢产物的产生减少。的主要竞争药是AIza／Sanofi-Syhthelabo公司的每天口服一次的奥音布宁缓释剂Ditropan XL及Pharmacia公司的每天一次的De trol LA（tolterocline，托特罗定酒石酸盐缓释片）。
在这项Ⅲ期研究中，520例病人用1.3mg、2.6mg或3.9mg／日或安慰剂贴片每周贴二次共治疗12周，随后有12周的公开标记、调整剂量期。3.9mg／日组的症状比安慰剂组有显著改善（P＜0.05）。例如，在每周尿失禁发作的中数次数，每天尿频的中数改变，每次排尿的尿量增加及尿失禁询问表上的评分都有改善。
最常见的副作用是贴片部位瘙痒，3.9mg／日组有16.8％的病人发生。较高剂量组9.6％的病人有口干，而安慰剂组是8.3％。双育期未有73例退出试验，其中53例是因有不良事件而退出的。

Oxytrol (oxybutynin) is a transdermal patch indicated for the treatment of overactive bladder in women who have symptoms of urge urinary incontinence, urgency and frequency. Oxytrol was originally developed by Watson Pharmaceuticals, which granted the marketing rights to Merck.
Oxytrol for Women was approved by the US Food and Drug Administration (FDA) for the treatment of overactive bladder in women in January 2013. It is the first over-the-counter treatment approved for the indication.
Watson Pharmaceuticals received European marketing authorisation for Kentera, the patch's European brand name, for the treatment of overactive bladder in June 2004. Oxytrol was also approved in Canada in 2004.
About overactive bladder (OAB)
Overactive bladder (OAB) is a urological condition, which is characterised by urge urinary incontinence, urgency and frequency. It occurs as a result of sudden and involuntary contraction of the wall muscle in the urinary bladder.
The disease affects more than 20 million women in the US. The majority of women affected are aged between 45 and 60 years.
Oxytrol's mechanism of action
Oxytrol contains anticholinergic medication, which is delivered through a transdermal patch on to the skin and into the bloodstream. The drug relieves urinary and bladder difficulties by decreasing the muscle spasms of the bladder.
The drug is administered in 3.9mg dose per day through patches. The transdermal patches are available in packs of four and eight. Each transdermal patch provides treatment for four days and nights.
Clinical trials of Oxytrol
A Phase I clinical trial of Oxytrol was conducted between September 2008 and January 2009. The randomised, double blind, efficacy study enrolled over 60 women with overactive bladder, aged between 40 and 75 years. The primary outcome measure of the study was comparison of maximum cystometric capacity at steady state after four hours of treatment with Oxytrol or placebo. The secondary outcome measures included comparison of maximum cystometric capacity four hours post-dose of oxytrol versus placebo.
The FDA approval of Oxytrol for Women was based on the results obtained from two Phase III controlled clinical studies and one open-label study.
The first Phase III clinical study was a randomised, double blind, placebo-controlled study. It was conducted on 520 subjects. The subjects were administered with Oxytrol at dose levels of 1.3mg, 2.6mg and 3.9mg/day or placebo.
The results of the study demonstrated that Oxytrol-administered patients showed significant reduction in weekly incontinence episodes, urinary frequency and urinary void volume when compared to placebo. The study was further continued by extending the treatment in an open-label study for another 40 weeks. The results showed that the urge or mixed incontinence with incontinence episodes in patients treated with Oxytrol reduced to 10 in a week.
The second Phase III study was a randomised, double blind, double-dummy trial that compared the safety and efficacy of Oxytrol 3.9mg/day to active and placebo controls. The study enrolled over 361 subjects.
The results of the study indicated that Oxytrol-administered patients showed a significant reduction in daily incontinence episodes, urinary frequency and urinary void volume when compared to placebo and active treatment groups.
What is Overactive Bladder (OAB)?
•OAB is a treatable medical condition characterized by 2 or more of the following symptoms:
urinary frequency (the need to urinate more often than usual; typically more than 8 times in 24 hours), urinary urgency (a strong need to urinate right away), and urge incontinence (leaking or wetting yourself if you cannot control the urge to urinate).
What is OXYTROL FOR WOMEN?
•OXYTROL FOR WOMEN (oxybutynin transdermal system, 3.9 mg/day) is the first-ever, over-the-counter treatment available to treat overactive bladder in women. This effective option can help women with OAB recognize and independently manage their symptoms.
What are the product features?
•OXYTROL FOR WOMEN is a thin, flexible and clear patch that is applied to the abdomen, hip or buttock every four days for the relief of overactive bladder in women.•OXYTROL FOR WOMEN can be worn during everyday activities, including showering or exercising. 
How does OXYTROL FOR WOMEN Work?
•Each OXYTROL FOR WOMEN patch delivers 3.9 mg of oxybutynin per day for a continuous four days and nights.
•By helping to relax the bladder muscle, OXYTROL FOR WOMEN helps reduce urinary urgency, frequency and accidents associated with OAB. 
When will OXYTROL FOR WOMEN be available?
•OXYTROL FOR WOMEN is expected to be available over-the-counter in the Fall of 2013.
附件：
201112517442915.PDF

--------------------------------------------------------------
产地国家: 美国
原产地英文商品名:
OXYTROL 3.9MG/PATCH 8PATCHS/BOX
原产地英文药品名:
OXYBUTYNIN
中文参考商品译名:
OXYTROL 3.9毫克/贴片 8贴片/盒
中文参考药品译名:
奥昔布宁
生产厂家中文参考译名:
华生实验室
生产厂家英文名:
WATSON LABS (UTAH)

该药品相关信息网址1:
http://www.oxytrol.com/
该药品相关信息网址2:
http://www.drugs.com/oxytrol.html
该药品相关信息网址3:
http://www.rxlist.com/oxytrol-drug.htm