治療情欲問題處方藥 女性用腦(Addyi) 男性用性

女性威而鋼 Addyi上市 提振女性情欲 時間：2015-10-18 06:39 全球第一種提振女性性欲的處方藥Addyi在17日上市，對性事興趣缺缺的女性，多半不會急於嘗試，不過總是多了一種選擇。Addyi被稱為「女性威而鋼」，但作用與藍色藥片威而鋼不同，是透過刺激腦部，以分泌較多和性需求相關的化學物質，而非如同威而鋼般直接作用於生殖器、增加血流量。根據福斯財經新聞網(Fox Business)提供的照片，Addyi是一種粉紅色藥片，須每日服用，不可與酒類和某些其他藥物混和使用，否則效果會打折扣，甚至產生低血壓和突然昏迷等不良副作用。不過這些限制也可能會激勵各藥廠為女性情欲問題研發更好的新藥。過去10多年來，世界各大藥廠都忽略了女性的這方面需要。美國亞特蘭大艾莫瑞大學(Emory University)心理學教授瓦倫(Kim Wallen)指出，Addyi是一道歷史性里程碑，為研發更多治療男女兩性問題的藥物開啟了大門。

副作用恐大於效果，「女性威而鋼」Addyi 值得妳為它冒險嗎？ 作者 尹雅楓 | 發布日期 2015 年 08 月 20 日醫療科技 美國食品藥物管理局（FDA）18 日批准了全球第一款用來促進女性性慾的藥物。這款被稱為是「女性威而鋼」的粉紅色小藥丸氟班色林（Flibanserin），由美國小型藥廠萌芽製藥廠（Sprout Pharmaceuticals）生產，公司將其命名為 Addyi，主要用來治療女性停經前、性慾低落的性功能障礙。Addyi 雖然暱稱為「女性威而鋼」，但與威而鋼不同的是，它是透過刺激腦中的化學物質，增強愉快記憶，而非像威而鋼直接作用於生殖器、增加血流量。在美國每十位女性中就有一位面臨性功能障礙困擾，但目前市面上只有治療男性性功能障礙問題的藥物，引發許多女性團體不滿，更有許多醫生、患者，以及女性健康活動家看到了男女在這方面醫療資源上的不平衡，都非常支持 Addyi 上市。然而，這款藥物也引來極大爭議，研究人員認為 Addyi 可能引起包括嗜睡、噁心等副作用，且 Addyi 不像威而鋼是單次服用，女性必須每日服用一顆，而這也可能增加患者與日常生活常接觸到的酒精、口服避孕藥、抗真菌藥物、普遍用於治療偏頭痛的「選擇性血清張力素致效劑（Triptans）」，以及其他藥物相牴觸的機會，產生不良影響，嚴重甚至會出現低血壓以及突然昏迷等症狀。由於擔心其副作用，Addyi 更曾兩度遭 FDA 拒絕。也有醫生指出，其實每種藥都有副作用，但它的風險與效果之間必須取得平衡，而根據 FDA 分析，僅有 8% 至 13% 的女性服用此藥物得到比安慰劑更好的效果，似乎顯示 Addyi 對於刺激女性性慾提升並沒有顯著成效，因此其帶來的副作用值得讓我們思考是否需要冒險。儘管如此，FDA 基於促進女性健康仍然對 Addyi 投了贊成票，且認為藥物與酒精或某些藥物同時服用，本來就有可能造成低血壓或是昏迷的風險，不過 FDA 藥物評價和研究部主任 Janet Woodcock 也表示，由於可能出現藥物間相互排斥的問題，未來將把 Addyi 列為處方藥，只能透過專業醫療人員或藥局認證才可購買；萌芽製藥廠也指出，希望 Addyi 能以處方藥於 10 月中旬上市。

Addyi Approval History  FDA approved: Yes (First approved August 18th, 2015)/ Brand name: Addyi/ Generic name: flibanserin/ Company: Sprout Pharmaceuticals, Inc. Treatment for: Hypoactive Sexual Desire Disorder/ Addyi (flibanserin) is a novel, non-hormonal, multifunctional serotonin agonist antagonist (MSAA) for the treatment of hypoactive sexual desire disorder in premenopausal women. Addyi (flibanserin) 100 mg tablets, developed by Sprout Pharmaceuticals, was FDA-approved on August 18, 2015 for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Flibanserin is the first approved medication for HSDD, and is classified as a multifunctional serotonin agonist antagonist (MSAA). According to the FDA, HSDD is characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to a co-existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance. HSDD is acquired when it develops in a patient who previously had no problems with sexual desire. HSDD is generalized when it occurs regardless of the type of sexual activity, the situation or the sexual partner. Flibanserin has been dubbed the "Female Viagra" and "the little pink pill"; however compared to Viagra, flibanserin has a distinctly different mechanism. The proposed mechanism of action of flibanserin involves regulation of several brain chemicals that may affect sexual desire, although the exact mechanism is not known. Flibanserin is a post-synaptic 5HT1A receptor agonist and 5HT2A receptor antagonist, as noted in FDA briefing documents, and has action in the central nervous system. The manufacturer states that flibanserin corrects an imbalance of dopamine and norepinephrine (both responsible for sexual excitement), while decreasing levels of serotonin (responsible for sexual satiety/inhibition). Flibanserin is not a hormonal drug and does not affect blood flow like the class of drugs approved for men with erectile dysfunction. Proponents of the drug emphasize the significant unmet need of a libido-enhancing drug for women. The effectiveness of the 100 mg bedtime dose of Addyi was evaluated in three 24-week randomized, double-blind, placebo-controlled trials in about 2,400 premenopausal women with acquired, generalized HSDD. On average, treatment with Addyi increased the number of satisfying sexual events by 0.5 to one additional event per month over placebo. Across the three trials, about 10 percent more Addyi-treated patients than placebo-treated patients reported meaningful improvements in satisfying sexual events, sexual desire or distress. Addyi has not been shown to enhance sexual performance. Side effects and drug interactions with flibanserin should be well understood by both provider and patient. Addyi is contraindicated for use with alcohol, in patients with liver impairment, and in patients taking moderate-to-strong CYP3A4 inhibitors. Addyi is being approved with a risk evaluation and mitigation strategy (REMS), which includes elements to assure safe use (ETASU), as well as a Black Box Warning. Adverse effect data showed the most common side effects were dizziness, nausea and sleepiness. The risk of fainting, particularly when combined with alcohol, is a major concern. Due to this interaction Addyi will only be available from certified health care professionals and certified pharmacies. Health care professionals must assess the likelihood of the patient reliably abstaining from alcohol before prescribing Addyi and pharmacists must counsel on this interaction. The risk of fainting is also increased due to drug interactions with moderate or strong CYP3A4 inhibitors that interfere with the breakdown of Addyi in the body. FDA is requiring the manufacturer to conduct additional post-marketing studies to better define the interaction between flibanserin and alcohol. Addyi is taken once daily, at bedtime, to help decrease the risk of fainting, sleepiness and sedation. Patients should discontinue treatment after eight weeks if they do not report an improvement in sexual desire and associated distress. Addyi is slated to be commercially available in October, 2015.