全球首款女性版伟哥 Addyi（flibanserin 中文译名 氟立班丝氨）可提升年轻女性性欲
系列的研究回顾表明，如果一个女人的性欲下降到让她感到绝望，或这已经引发了一定问题的时候，那么被称为“女性伟哥”的药物或许可以帮到她。
主要研究者Michael Krychman博士表示，一种被称为氟班色林（Addyi）的药物，于2015年经美国食品和药物管理局（FDA）批准，针对绝经前女性，用于提高她们性欲，增加她们性行为的满意度。但他也说，这种药物本身并不是全面治疗女性性欲低下的治疗手段。
“健康的性生活和身体健康是多方面因素的问题，所以女性有不止一个性方面的问题或抱怨很常见。” Krychman说到。
Krychman是新港滩加利福尼亚南部性健康和幸存者中心的执行董事。
Krychman表示，性欲低下会令人不安，而且它影响到女性的自尊和性生活，但现在有安全且有效的治疗方法。对大多数女性而言，药物治疗只是改善这类问题的一方面。药物治疗联合心理干预可以帮助女性激发性欲，她们不需要再沉默忍受。女性也有寻求性健康和治疗的权利，她们没必要感到尴尬或羞耻。
在研究中，研究人员收集了超过2，300名绝经前女性的试验数据，分别给予她们Addyi和安慰剂，进行连续3个24周的研究。所有女性均有性欲减退问题，这意味着性欲减退问题已经困扰了她们很久或在性关系中引发了一定的问题。
使用女性性功能指数来评价药物反应。性功能指数包括性欲望、性唤起、湿润度、性高潮、满意度和疼痛。
与安慰剂组相比，每日服用Addyi的女性在性欲和其他功能指标方面都有显着的改善。
研究的细节将于周日在波士顿召开的美国泌尿协会的年会上公布。会议上公布的研究一般被视为初步研究，直至该研究在同行评议的期刊上发表。
Krychman说，暂时还不明确Addyi的具体工作机理，但它似乎能够改变大脑中神经系统的血清素，从而影心情和身体的其他功能。
根据FDA的批准，该药物只适用于绝经前女性，而不适用于绝经后女性或男性。
常见的副作用:是嗜睡和眩晕，但通常药物都是睡前服用，所以这些影响的伤害不大。其他副作用为恶心、疲劳、失眠和口干。
Addyi，多年来经历了几次所有权的变更，目前由Valeant Pharmaceuticals生产。
Krychman团队关于Addyi的整个研究均由Addyi制造商资助完成。
一位专家不认为药物可以解决与女性性欲低下相关的真正问题。
纽约市Lenox Hill 医院泌尿外科专家，Elizabeth Kavaler博士说：“答案不仅仅是一片药片，我感觉就像是你给了一名女性一片药，然后她就会产生性欲。”
但其他的一切呢？
“两个人的关系和亲密度，其他一切能让女性感觉良好并想要做爱的那些呢？” Kavaler问道。“那些能够刺激到女性性行为的方式有运动、健康的饮食、良好的身体想象和其他能够对自己生活感到好的东西都可以。”
这并不是说女性不想要去尝试Addyi，但提高性欲不能忽视构建成功两性关系的其他所有的因素，Kavaler说。
“如果你没有其他选择了，并且能从药物治疗中获得积极的效果，那就可以了。”

The first and only FDA-approved treatment for acquired, generalized Hypoactive Sexual Desire Disorder (HSDD) in premenopausal women
General Information
Addyi (flibanserin) is a serotonin 1A receptor agonist and a serotonin 2A receptor antagonist.
Addyi is specifically indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD) as characterized by low sexual desire that causes marked distress or interpersonal difficulty.
Addyi is supplied as a tablet for oral administration. The recommended dosage is 100 mg taken once daily at bedtime. Addyi should be dosed at bedtime because administration during waking hours increases risks of hypotension, syncope, accidental injury, and central nervous system (CNS) depression. Discontinue treatment after 8 weeks if no improvement is observed.
Clinical Results
FDA Approval
The FDA approval of Addyi was based on three 24- week, randomized, double-blind, placebo-controlled trials (Studies 1, 2, and 3). The three trials included premenopausal women with acquired, generalized HSDD of at least 6 months duration. In the clinical trials, acquired HSDD was defined as HSDD that developed in subjects who previously had no problems with sexual desire. Generalized HSDD was defined as HSDD that was not limited to certain types of stimulation, situations or partners. The subjects were treated with Addyi 100 mg once daily at bedtime (n = 1187) or placebo (n = 1188). These trials each had two co-primary efficacy endpoints, one for satisfying sexual events (SSEs) and the other for sexual desire:
The change from baseline to Week 24 in the number of monthly SSEs (i.e., sexual intercourse, oral sex, masturbation, or genital stimulation by the partner). The SSEs were based on patient responses to the following questions: “Did you have a sexual event?” and “Was the sex satisfying for you?”
Studies 1 and 2 had a different sexual desire endpoint than Study 3:
In Studies 1 and 2, the sexual desire co-primary endpoint was the change from baseline to Week 24 in the calculated monthly sexual desire score and was based on patient responses to the question: “Indicate your most intense level of sexual desire.” Every day, patients rated their sexual desire level from 0 (no desire) to 3 (strong desire) and recorded their response in an electronic Diary (eDiary). These responses were summed over a 28-day period to yield the calculated monthly sexual desire score, which ranged from 0 to 84.
In Study 3, the desire domain of the Female Sexual Function Index (FSFI Desire) was the sexual desire co-primary endpoint.
The desire domain of the FSFI has two questions. The first question asks patients “Over the past 4 weeks, how often did you feel sexual desire or interest?”, with responses ranging from 1 (almost never or never) to 5 (almost always or always).
The second question asks patients “Over the past 4 weeks, how would you rate your level (degree) of sexual desire or interest?”, with responses ranging from 1 (very low or none at all) to 5 (very high).
The FSFI Desire score was calculated by adding the patient’s responses to these two questions then multiplying that sum by 0.6. The FSFI Desire domain score ranged from 1.2 to 6.
In all three trials, Addyi resulted in statistically significant improvement compared to placebo in the change from baseline in monthly SSEs at Week 24. In Study 1 and 2, there were no statistically significant differences between Addyi and placebo for the eDiary sexual desire endpoint (change in baseline to Week 24). In contrast, in Study 3 there was statistically significant improvement in the change from baseline to Week 24 in sexual desire (using the FSFI Desire Domain) with Addyi compared to placebo.
Addyi comes with a boxed warning label:
The use of Addyi and alcohol increases the risk of severe hypotension and syncope; therefore, alcohol use is contraindicated.
Addyi is available only through a restricted program called the Addyi REMS Program.
Severe hypotension and syncope can occur when Addyi is used with moderate or strong CYP3A4 inhibitors or in patients with hepatic impairment; therefore, Addyi use in these settings is contraindicated.
Mechanism of Action
Addyi (flibanserin) is a serotonin 1A receptor agonist and a serotonin 2A receptor antagonist, but the mechanism by which the drug improves sexual desire and related distress is not known.
Studies 1 and 2 had a different sexual desire endpoint than Study 3:
In Studies 1 and 2, the sexual desire co-primary endpoint was the change from baseline to Week 24 in the calculated monthly sexual desire score and was based on patient responses to the question: “Indicate your most intense level of sexual desire.” Every day, patients rated their sexual desire level from 0 (no desire) to 3 (strong desire) and recorded their response in an electronic Diary (eDiary). These responses were summed over a 28-day period to yield the calculated monthly sexual desire score, which ranged from 0 to 84.
In Study 3, the desire domain of the Female Sexual Function Index (FSFI Desire) was the sexual desire co-primary endpoint.
The desire domain of the FSFI has two questions. The first question asks patients “Over the past 4 weeks, how often did you feel sexual desire or interest?”, with responses ranging from 1 (almost never or never) to 5 (almost always or always).
The second question asks patients “Over the past 4 weeks, how would you rate your level (degree) of sexual desire or interest?”, with responses ranging from 1 (very low or none at all) to 5 (very high).
The FSFI Desire score was calculated by adding the patient’s responses to these two questions then multiplying that sum by 0.6. The FSFI Desire domain score ranged from 1.2 to 6.
In all three trials, Addyi resulted in statistically significant improvement compared to placebo in the change from baseline in monthly SSEs at Week 24. In Study 1 and 2, there were no statistically significant differences between Addyi and placebo for the eDiary sexual desire endpoint (change in baseline to Week 24). In contrast, in Study 3 there was statistically significant improvement in the change from baseline to Week 24 in sexual desire (using the FSFI Desire Domain) with Addyi compared to placebo.
Addyi comes with a boxed warning label:
The use of Addyi and alcohol increases the risk of severe hypotension and syncope; therefore, alcohol use is contraindicated.
Addyi is available only through a restricted program called the Addyi REMS Program.
Severe hypotension and syncope can occur when Addyi is used with moderate or strong CYP3A4 inhibitors or in patients with hepatic impairment; therefore, Addyi use in these settings is contraindicated.
Mechanism of Action
Addyi (flibanserin) is a serotonin 1A receptor agonist and a serotonin 2A receptor antagonist, but the mechanism by which the drug improves sexual desire and related distress is not known.
Addyi(Flibanserin Tablets, for Oral Use)
ADDYI Rx   
Generic Name and Formulations:
Flibanserin 100mg; tabs.
Company:
Sprout Pharmaceuticals
Indications for ADDYI:
Acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women and is not due to a coexisting medical or psychiatric condition, problems within the relationship, or adverse effect of a medication or other drug substance.
Limitations Of use:
Not for HSDD in postmenopausal women or men. Not for sexual performance enhancement.
Adult:
100mg daily at bedtime. Discontinue if no improvement after 8 weeks.
Children:
Not recommended.
Contraindications:
Concomitant alcohol, moderate or strong CYP3A4 inhibitors (eg, azole antifungals, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, boceprevir, telaprevir, telithromycin, conivaptan, amprenavir, atazanavir, ciprofloxacin, diltiazem, erythromycin, fosamprenavir, verapamil, grapefruit juice). Hepatic impairment.
Warnings/Precautions:
Increased risk of severe hypotension and syncope with concomitant alcohol use. Assess patient's likelihood of alcohol abstinence prior to prescribing. Increased risk of CNS depression if taken during waking hours. Conditions that predispose to hypotension. CYP2C19 poor metabolizers; monitor. Pregnancy. Nursing mothers: not recommended.
Interactions:
See Contraindications. Increased risk of hypotension and syncope with concomitant moderate or strong CYP3A4 inhibitors, if use necessary, discontinue Addyi at least 2 days before starting the CYP3A4 inhibitor; discontinue the CYP3A4 inhibitor for 2 weeks before restarting Addyi. Increased risk of CNS depression with alcohol, other CNS depressants (eg, diphenhydramine, opioids, hypnotics, benzodiazepines), or strong CYP2C19 inhibitors (eg, PPIs, SSRIs, antifungals). Potentiated by weak CYP3A4 inhibitors (eg, oral contraceptives cimetidine, fluoxetine, ginkgo, resveratrol, ranitidine). Antagonized by CYP3A4 inducers (eg, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, St. Johns wort): not recommended. Potentiates digoxin, sirolimus, other P-gp substrates: monitor levels.
Pharmacological Class:
5-HT1A agonist/5-HT2A antagonist.
Adverse Reactions:
Dizziness, somnolence, nausea, fatigue, insomnia, dry mouth; hypotension, syncope.
REMS:
YES
Generic Availability:
NO
How Supplied:
Tabs—30