【关爱女性】粉色小药丸Addyi上市半年,疗效再次受质疑
2016/03/08
在2015年之前,没有任何一款针对女性性功能障碍的药物面世。截止到“三八妇女节”来临,针对成年女性性功能障碍的粉色小药丸Addyi上市半年有余,其对女性的帮助有多大呢?Addyi上市半年后,女用伟哥在经过市场的投放后恶评不断,被指药效差副作用多。

全球超3成女性经历“性欲衰退”,“女性伟哥”紧缺

根据流行病学调查结果:中国30至60岁男性中有28%的人存在勃起功能障碍,FDA已经目前批准了26种药物。辉瑞的明星产品“伟哥”(万艾可)仅在中国就赢得了近6800万潜在城市用户,2015年销售额的销售额高达10亿元。

2002年的一项调查表明:全球约有1/3的成年女性正经历“性欲衰退”(女性缺少性欲或性幻想);北京大学第一医院男科中心专家对我国540名23岁-55岁的健康女性调查显示:55.5%的女性对性生活不满意,39.68%自称性高潮困难,性生活每月少于2次者占31.75%;还有统计数据显示:43%的女性患有不同程度的性功能障碍,甚至有部分患者一辈子从未尝试过高潮。

医院专家表示:女性一生中会经历怀孕、分娩、哺乳及绝经等特殊生理事件,多数女性会遭遇特殊时期的性功能障碍,但是很少有女性来医院就诊,往往也无处可医。且在2015年之前,没有任何一款针对女性性功能障碍的药物面世。


粉色小药丸Addyi结构式

FDA批准全球首款粉色小药丸,遭遇市场销售不济

随着男性性功能障碍研究得到发展,女性性功能障碍的问题也逐渐引起人们的关注。2015年8月18日,FDA以18比6的投票正式批准了女性性功能障碍产品flibanserin以商品名“Addyi”上市,这成为了一场“关怀女性性生活”的里程碑。截止到“三八妇女节”来临,针对成年女性性功能障碍的粉色小药丸Addyi上市半年有余,其对女性的帮助有多大呢?

随着“三八妇女节”的来临,女性专用“粉色小药丸”再一次成为头条。商品名为Addyi的“粉色小药丸”适应症为女性性功能障碍,自诞生之日就饱受争议。该药于去年秋季获批后,该药及其归属公司Sprout制药被Valeant以10亿美元高价收购。不过,由于上市销售额惨淡,以及更棘手的母公司问题,Addyi很快就淡出公众视线。现在,JAMA(美国医疗协会杂志)发表的一篇文章,又一次把Addyi推到了风口浪尖。

在2月29日发表的文章中,研究人员称,Addyi使用者平均每月的满意性生活数量增加一半。研究选取了5篇已发表的文章和3篇未发表的文章,共对5900余名女性性功能障碍患者进行了研究。结果显示:在服用药物的女性当中,大约有8%至于13%的人比仅服用安慰剂的女性在性生活满意度方面有了显著改善,粉红色药片的实际效果低于此前的实验结果——即每天服用“女用伟哥”只能保证平均每两个月过一次完全令人感到满意的性生活。

JAMA的社论得出以下及理论:FDA的药物审批程序应该“在得到足够的证据之后,再下结论”,从这个角度来看,“在Addyi的审批过程中,FDA的做法显然得不到认可。”

女性性功能障碍:由心理和身体双重因素引起

男女的性功能障碍,在机理上就存在差别。女性性功能障碍,更多地表现为性欲低下、性欲唤起障碍、性高潮障碍等“主观性”的变化。社区流行病调研发现,婚后第一年女性性功能障碍尤为明显,有八成女性有性高潮障碍。

过去认为女性性功能障碍有90%是心理因素引起,而现在医学认为内分泌因素、神经因素、血管性因素、肌肉和药物性因素也是导致女性性功能障碍的重要原因。婚姻专家甚至发现性问题常出现在第一个孩子的出生年,会阴切开术疤痕疼痛、担心再次怀孕、体形的改变及疲劳等等均为女性躲避甚至厌恶性生活的原因。

关于“女性伟哥”Addyi的常识


Addyi的包装

(一)哪里可以买?怎么买?多少钱?

粉红小药丸已经在美国开售,每个月的剂量价格大概在30~75美元之间;Addyi属于处方药,不能随意购买,服用前须充分评估其风险性,需要医生开处方才能购买;尚未受到中国CFDA批准,中国无法购买。相关用法可参考https://www.addyi.com/网站。

(二)Addyi真是粉红版的伟哥吗?

当然不是!Addyi的作用不同于通常用来治疗勃起功能障碍的伟哥,后者自1998年上市。Addyi作用于脑部以提高性欲,而伟哥通过影响生殖器血流而起作用,并不改善性欲。

(三)如何服用?Addyi的不良反应和副作用有哪些?

Addyi(100mg剂量)每日睡前口服一次,在睡前给药能够帮助降低不良事件发生的风险,常见不良反应包括头晕、嗜睡(困倦)、恶心、乏力、失眠和口干等。

此外,服药期间饮酒可能会出现严重的低血压或晕厥。若患者接受8周治疗后,性满足和相关痛苦未得到改善,应停止治疗。

(四)女性性欲低下常见吗?

在全球,绝经前女性(18~55岁)性欲低下的发病率约为10%(发展中国家远高于这一水平)。性欲低下(HSDD)是指非由物质或一般医疗状况所致的持续地或反复地对性生活的欲望以及性幻想不足或完全缺失,且由此给患者带来显著的苦恼或人际交往困难。

(五)女性性功能障碍没有必要治疗?

研究表明:女性性功能障碍会对女性患者的健康相关生活质量造成重要损害,其损害程度不亚于糖尿病,会造成患者的严重负担。

更多详情:

MEDICATION GUIDE ADDYI™ (add-ee)(flibanserin) Tablets

  • 2016/11/08
    11月1日,总部位于新泽西州克兰布利的小公司Palatin Technologies(帕拉丁科技)发布了一条令人振奋的消息,其用于治疗女性遭受性欲减退障碍的在研新药bremelanotide在两项III期研究中到达了主要终点,可以显著提高性欲,改善性苦恼评分,到达了复合终点。预计2017年年中提交上市申请,最早2018年可摆上货架。
  • 2016/11/03
    许多的制药公司想要针对女性性欲低下开发药物。现在,美国食品和药物管理局(FDA)颁布了此类药物开发的最新准则。
  • 2016/04/10
    全球首个女性性欲功能减退障碍治疗药物Addyi(氟班色林)原本是勃林格手中近乎烂尾的项目。Sprout公司2012年接手后以死缠烂打的劲头“迫使”FDA在2015年8月批准其上市。在Addyi获批2个月后,Sprout便投入Valeant的怀抱,把自己卖了个10亿美元的好价钱。
查看更多
  • Efficacy and Safety of Flibanserin for the Treatment of Hypoactive Sexual Desire Disorder in Women A Systematic Review and Meta-Analysis

    Importance In August 2015, the US Food and Drug Administration (FDA) approved flibanserin as a treatment for hypoactive sexual desire disorder (HSDD) in premenopausal women, despite concern about suboptimal risk-benefit trade-offs. Objective To conduct a systematic review and meta-analysis of randomized clinical trials assessing efficacy and safety of flibanserin for the treatment of HSDD in women. Data Sources Medical databases (among others, Embase, Medline, Psycinfo) and trial registries were searched from inception to June 17, 2015. Reference lists of retrieved studies were searched for additional publications. Study Selection Randomized clinical trials assessing treatment effects of flibanserin in premenopausal and postmenopausal women were eligible. No age, language, or date restrictions were applied. Abstract and full-text selection was done by 2 independent reviewers. Data Extraction and Synthesis Data were extracted by one reviewer and checked by a second reviewer. Results were pooled using 2 approaches depending on the blinding risk of bias. Main Outcomes and Measures Primary efficacy outcomes included number of satisfying sexual events (SSEs), eDiary sexual desire, and Female Sexual Function Index (FSFI) desire. Safety outcomes included, among others, 4 common adverse events (AEs): dizziness, somnolence, nausea, and fatigue. Results Five published and 3 unpublished studies including 5914 women were included. Pooled mean differences for SSE change from baseline were 0.49 (95% CI, 0.32-0.67) between 100-mg flibanserin and placebo, 1.63 (95% CI, 0.45-2.82) for eDiary desire, and 0.27 (95% CI, 0.17-0.38) for FSFI desire. The risk ratio for study discontinuation due to AEs was 2.19 (95% CI, 1.50-3.20). The risk ratio for dizziness was 4.00 (95% CI, 2.56-6.27) in flibanserin vs placebo, 3.97 (95% CI, 3.01-5.24) for somnolence, 2.35 (95% CI, 1.85-2.98) for nausea, and 1.64 (95% CI, 1.27-2.13) for fatigue. Women’s mean global impression of improvement scores indicated minimal improvement to no change. Conclusions and Relevance Treatment with flibanserin, on average, resulted in one-half additional SSE per month while statistically and clinically significantly increasing the risk of dizziness, somnolence, nausea, and fatigue. Overall, the quality of the evidence was graded as very low. Before flibanserin can be recommended in guidelines and clinical practice, future studies should include women from diverse populations, particularly women with comorbidities, medication use, and surgical menopause.

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  • US Food and Drug Administration Approval of Flibanserin

    Flibanserin (Addyi), the new female libido pill, is about desire, arousal, and satisfaction. The manufacturer, Sprout Pharmaceuticals (a division of Valeant Pharmaceuticals North America LLC), clearly had desire. They purchased the rights to the drug even after its initial rejection by the US Food and Drug Administration (FDA) and persisted through 2 contentious review cycles. Sprout worked hard to arouse support for the drug, helping create and fund “Even the Score,” an advocacy campaign pushing the message that sexism—not legitimate scientific questions—motivated the drug’s rejection.1 And within 48 hours of FDA approval, flibanserin was sold to Valeant Pharmaceuticals for about $1 billion in cash.2 Very satisfying. Very satisfying for Sprout, but what about the women who take flibanserin? What happens to their desire, arousal, and satisfaction? Very little, according to the meta-analysis by Jaspers et al3 in this issue. Premenopausal and postmenopausal women taking the approved dose—compared with placebo—experienced 0.5 more satisfying sexual encounters a month and scored 0.3 points higher on a 5-point sexual desire scale. Jaspers et al concluded that these modest benefits did not outweigh harms. According to the FDA, about 10% more premenopausal women taking the approved dose (100 mg) of flibanserin had a meaningful benefit (ie, were “much” or “very much” improved), but flibanserin increased somonolence, sedation, or fatigue compared with placebo: 21% vs 8%.4 Perhaps most importantly, combining flibanserin with alcohol (and other common drugs) can cause dangerous hypotension and syncope—problems so serious that the FDA put a black box warning, its most serious safety alert, on the label.

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