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FDA再次拒绝Remoxy治疗严重疼痛

2018-08-06 MedSci MedSci原创

Remoxy严重疼痛羟考酮
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Pain Therapeutics近日表示，FDA咨询委员会再次拒绝Remoxy（羟考酮）治疗严重疼痛的申请。

Pain Therapeutics近日表示，FDA咨询委员会再次拒绝Remoxy（羟考酮）治疗严重疼痛的申请。FDA确定NDA中提交的数据不支持Remoxy的收益超过风险的结论。羟考酮（oxycodone）是从生物碱蒂巴因（thebaine）中提取的半合成阿片类药物，作为强效镇痛药在临床上应用已有80多年的历史。由于羟考酮生物利用度高，给药途径多，因而在临床上应用广泛。但在临床发现在高剂量连续使用羟考酮后，突然中断或减量，部分病人有戒断综合征的发生。这提示羟考酮同样具有其它阿片类药物常见的不良反应。羟考酮主要通过激动中枢神经系统内的阿片受体而起镇痛作用，镇痛效力中等。

严重疼痛是指患者需要每日、全天候、长期服用阿片类药物，同时面临着替代治疗方案无效的问题。但是FDA认为Remoxy（羟考酮）不具有显著的收益风险比，因此投票反对Remoxy治疗严重疼痛的申请。


原始出处：

http://www.firstwordpharma.com/node/1583140?tsid=4#axzz5NCMJrdAy

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    2018-08-16 tongyongming

    #REM#

    0

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    2018-08-08 sillywu

    疼痛的治疗是一个很古老的话题

    0

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    2018-08-07 liumin1987

    嗯嗯，学习了。

    0

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    2018-08-07 牛顿爱吃苹果

    学习了

    0

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    2018-08-07 太阳系小猪

    要获批还是很难的，不是光有用就可以~

    0

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    2018-08-06 清风拂面

    谢谢分享学习

    0

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    2018-08-06 1e1b8538m79(暂无匿称)

    不错的文章值得拥有哦

    0

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    2018-08-06 惠映实验室

    学习了，谢谢分享。

    0

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    2018-08-06 医者仁心5538

    学习了

    0

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