2月11日，Sprout Pharmaceuticals收到FDA关于flibanserin的完全答复函，FDA要求增加三项临床试验，其中两项研究flibanserin与其他药物的相互作用，第三项要求模拟驾驶，因为近10%的女性服用该药后出现昏睡。Flibanserin是Sprout研发的5-HT1A受体激动剂、5-HT2A受体拮抗剂，用于治疗女性性欲障碍（hypoactive sexual desire disorder），2010年FDA以疗效轻微且有头昏、恶心、疲乏等副作用为由拒绝该药，随后Sprout提出申诉。
flibanserin中文翻译为氟班色林，氟班色林（flibanserin），一种用于提高女性性欲的药物，能减少抑制性欲的5—羟色胺，以提高刺激性欲的多巴胺水平。
研究历时半年，由德国药厂勃林格殷格翰（Boehringer Ingelheim）资助，并由美国北卡罗莱纳大学、弗吉尼亚大学、加拿大渥太华医院女性健康中心和意大利帕维亚大学联合参与。参与研究的科学家，周一在欧洲性医学协会于法国里昂举行会议时，公布了有关成果。
德国的勃林格殷格翰(Boehringer Ingelheim)于2009年11月16日在欧洲性学会会议上公布了氟班色林(flibanserin)的三期临床试验结果，称其对绝经前妇女性欲低下（HSDD）显示出良好疗效和耐受性。临床三期有5000多名月经正 常的机能减退性欲障碍者参试，在美国、加拿大、欧洲进行，在北美的两个临床试验虽然用药组和对照组有统计学上的差异，但尚无法证明能够提高性欲，从设计的 角度，这两个临床试验以失败告终。
尽管如此，勃林格殷格翰公司还是于2009年底公布结果，宣称flibanserin效果很好，副作用通常比较轻微，包括头晕、恶心、嗜睡、失眠、疲倦等。
2010年，FDA专家委员会以一致意见驳回flibanserin的申请，勃林格殷格翰公司随即宣布放弃flibanserin的研究。
次年，Sprout药厂接过flibanserin，继续进行临床试验，一共做了14项临床试验，参试者3000多人，加上勃林格殷格翰公司的数 据，Sprout药厂一共整理了11000多人的数据，与2013年6月再次向FDA提出申请，宣称用药组28天内满意的性行为2.5次。对照组为1.5 次。
2013年12月，FDA专家组再次以一致意见驳回flibanserin上市申请。Sprout药厂随即提出上诉。
Sprout Pharmaceuticals Receives Clear Guidance From FDA On Path Forward To Resubmit New Drug Application For Flibanserin, The First Potential Medical Treatment For Hypoactive Sexual Desire Disorder In Premenopausal Women
Agency Proposes select Phase I Studies as Part of Resubmission
PR Newswire
RALEIGH, N.C., Feb. 11, 2014
RALEIGH, N.C., Feb. 11, 2014 /PRNewswire/ -- Sprout Pharmaceuticals announced today that their Formal Dispute Resolution, which was filed in December 2013, resulted in clear guidance from the FDA on the path forward. Sprout will resubmit the New Drug Application (NDA) for flibanserin, a once-daily treatment for Hypoactive Sexual Desire Disorder (HSDD) in premenopausal women, by the third quarter.
The FDA has requested that Sprout complete two additional Phase I drug interaction studies and a Phase I driving simulator study. Consistent with their Phase I nature, each study is expected to include approximately 25-50 healthy volunteers. These studies will answer interaction questions on different enzyme pathways than those already studied, as well as identify if there is any possible driving impairment, as 9.8% of women experience somnolence, or sleepiness, while on flibanserin 100mg.
"We are encouraged by the FDA's response and view it as a significant step toward the approval of flibanserin," said Cindy Whitehead, president and chief operating officer of Sprout Pharmaceuticals. "With data in over 11,000 patients to date, we are confident that further supporting the predictable risk/benefit profile of flibanserin will result in women having the first ever treatment for the most common form of female sexual dysfunction. We are committed to working closely with the Agency to finally provide premenopausal women affected by HSDD with a medical treatment option."
About Hypoactive Sexual Desire Disorder
HSDD is the most commonly reported form of female sexual dysfunction. HSDD is defined as a persistent or recurrent deficiency or absence of sexual fantasies and desire for sexual activity that causes marked distress or interpersonal difficulty, and which is not better accounted for by a medical, substance-related, psychiatric (e.g., depression) or other sexual condition. The cause of HSDD is believed to involve a multitude of social, psychological and biological factors and may be attributed to a complex interplay of these factors.
About Flibanserin
Flibanserin is a novel, non-hormonal drug that has been studied in clinical trials for the treatment of HSDD in premenopausal and postmenopausal women. The application submitted to the FDA is for premenopausal women. Flibanserin is believed to work on key neurotransmitters, or chemicals, in the brain that affect sexual desire. More specifically, it is thought that flibanserin corrects an imbalance of levels of these neurotransmitters by increasing dopamine and norepinephrine (both responsible for sexual excitement) and decreasing serotonin (responsible for sexual inhibition). In clinical studies, flibanserin was evaluated for its ability to increase the frequency of satisfying sexual events, increase the intensity of sexual desire and decrease the associated distress women feel from its loss.
About Sprout Pharmaceuticals
Sprout Pharmaceuticals is passionate about women's sexual health. With a breakthrough concept for women, the company "sprouted" out of Slate Pharmaceuticals in 2011. Based in Raleigh, NC, the company is focused solely on the delivery of a treatment option for the unmet need of millions of women with HSDD. Sprout is pursuing the FDA approval of flibanserin to treat HSDD in premenopausal women, for which there is currently no FDA-approved treatment.
Read more: http://www.digitaljournal.com/pr/1730927#ixzz2t5NHLuB8
关键词： FDA Sprout 女性性欲障碍治疗药 Flibanserin 临床试验
免责声明：
本文仅供专业人士学术交流探讨，不作为诊疗及用药依据。
如有侵权，请联系我们删除