(早洩) 歐盟上市Lidocaine+Prilocaine 噴劑 /美國將成為一藥物

早洩噴劑 助快槍俠展5倍雄風 【2013/9/24 01:15】 〔中央社〕壯陽藥「威而鋼」發明人魏里（Mike Wyllie）研發出治療早洩噴劑Tempe，試驗顯示此噴劑能讓男性提高5倍持久力。歐盟藥品管理局認定此藥物安全有效，可望於明年初上市。英國「每日郵報」（Daily Mail）報導，威而鋼（Viagra）發明人魏里博士宣稱，這種新藥可協助更多人享受魚水之歡。90年代研發出威而鋼團隊成員之一的魏里正準備推出治療早洩噴劑Tempe。歐洲藥品管理局（EMA）認定，Tempe安全有效，最早可望於明年初上市。報導說，每4名男子平均至少1人有早洩困擾，較威而鋼治療的勃起困難更常見。在臨床實驗中，於嘿咻前使用此噴劑的男子，持久力平均延長5倍。做愛時間延長，也讓女性受益，男女兩性都對性生活表達更大滿意度。早洩可能打擊男性自尊，讓建立和維持關係變得困難，在更糟情況下，它可能讓伴侶無法懷孕。目前市面上只有一種藥物專供治療早洩，但價格昂貴，且在英國境內無法普遍取得。早洩的確實原因不明，據信與過度敏感有關。Tempe噴劑內含兩種低劑量麻醉藥，可協助男人提高掌控力。此噴劑約5分鐘就見效，但嘿咻前兩小時使用也管用。如果男性每個月行房5到6次，袖珍型1小罐可使用長達1年。但一些試用此噴劑的男子，出現包括灼熱感和頭痛等副作用。也有人擔心使用此藥物充當「應急之道」，將會妨礙伴侶面對引發早洩的真正問題，諸如壓力、焦慮和關係緊張等。

What Is TEMPE Spray? TEMPE (Topical eutectic-like mixture for premature ejaculation) now approved in Europe with the name of "Lidocaine Prilocaine Plethora" is a rapidly acting spray formulation of two local anaesthetics (three metered doses of the spray applied to the glans of the penis delivering 22.5mg lidocaine and 7.5mg prilocaine) for the treatment of premature ejaculation (PE) and developed by Plethora Solutions Ltd, London. It is spritzed onto the tip of the penis few minutes (<5 minutes) before sex and does not require condom use. Lidocaine Prilocaine Plethora spray (also known as TEMPE or PSD502) delivers a localised application of anaesthetic and is rapidly absorbed by the non- keratinised skin of the glans penis.The anaesthetic in Lidocaine Prilocaine Plethora spray doesn't penetrate intact or fully keratinised skin and can be easily wiped off with a damp cloth in order to minimise transference to the sexual partner. Lidocaine Prilocaine Plethora spray was also well tolerated by the female partners, with reports of 3.9% vulvovaginal discomfort or burning sensation caused discontinuation of treatment in 0.3% of subjects. Studies have demonstrated that the onset of action of Lidocaine Prilocaine Plethora spray is within minutes (<5) and that the benefit lasts for at least 2 hours. The product will be commercialized in the mid-to late-2014, across all 27 member states in Europe (UK, Germany, Spain, France, Italy, Netherlands, Portugal, Sweden, and so on). Plethora Spray has met all co-primary endpoints with the USA-FDA Phase III study: The intra-vaginal ejaculation latency time (IELT) was increased at least six-fold with Tempe Spray when compared to baseline. There was a 5 point difference between Tempe Spray and placebo in the Index of Premature Ejaculation (IPE) domains for ejaculatory control and sexual satisfaction, where a 2 point difference is considered clinically significant. IPE domain for Distress was a 2.5-point difference between Tempe Spray and placebo, where a 2 point difference is considered clinically significant. And partner satisfaction, as a secondary endpoint, was also found considerably greater with Tempe Spray than placebo. Plethora Spray was well tolerated and only a very low incidence of mild penile numbing (<3%) was observed. Plethora Spray Phase III recruitment programme in the USA is now completed for the treatment of premature ejaculation. Plethora Spray would be the first prescription treatment in the United States for premature ejaculation, upon FDA approval. In Europe, a phase III study data show on average, men who got the spray lasted 6.3 times longer than those who got the placebo.  Results of a phase III clinical trials with 300 heterosexual men with premature ejaculation shows that 90% of the men in the treatment with TEMPE spray were able to delay ejaculation for more than one minute following vaginal penetration, 74% of men last more than two minutes before ejaculation and 62% of men with TEMPE spray said their orgasms were 'good' or 'very good' after three months. The men had an average age of 35. On November 19, 2013, the European Commission has granted marketing authorisation under the name 'Prilocaine Lidocaine Plethora', to treat primary premature ejaculation in adult men.