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Information on Priligy
Beerse, Belgium, 10 February, 2009 - Janssen-Cilag EMEA, a division of Janssen Pharmaceutica N. V., announced today that Priligy (dapoxetine) has received marketing authorisation in Finland and Sweden for the on-demand treatment of premature ejaculation (PE) in men 18–64 years of age. These approvals follow the positive outcome of a decentralised marketing authorisation procedure in seven European Union countries: Sweden, Austria, Finland, Germany, Spain, Italy and Portugal. The procedure was finalised in December 2008, and Finland and Sweden are the first countries worldwide to grant marketing authorisation for this compound. National approvals and licenses in the other five European countries are expected to follow. Dapoxetine is a drug specifically developed for the on-demand treatment of PE and is the first oral medication (tablet) to be approved for this condition. Dapoxetine has been extensively evaluated in five randomised, placebo-controlled Phase III clinical trials involving more than 6,000 men with PE and their partners. This is the largest and most comprehensive clinical trial programme to date for a drug therapy to treat PE 1-3. Dapoxetine is a unique, short-acting, selective serotonin reuptake inhibitor (SSRI) designed to be taken only when needed, that is 1–3 hours before sexual intercourse is anticipated, rather than every day 2. Premature Ejaculation PE is a distressing sexual dysfunction that can be present from the first sexual encounter or can develop later in life. Depending on the methodology and criteria used to evaluate the prevalence of PE in studies, the reported proportion of men affected with this condition at some point in their lives has ranged from 4–30% 4. Experts in PE from the International Society of Sexual Medicine (ISSM) define the condition as consisting of three major components: a short time to ejaculation, lack of ejaculatory control and negative personal impact or distress related to ejaculation. The condition is defined by the ISSM as “a male sexual dysfunction characterised by ejaculation which always or nearly always occurs prior to or within about one minute of vaginal penetration; and inability to delay ejaculation on all or nearly all vaginal penetrations; and negative personal consequences, such as distress, bother, frustration and/or the avoidance of sexual intimacy” 5. Unlike erectile dysfunction (ED), which tends to affect older men, PE has similar prevalence across all age groups 6. In fact, more men are believed to experience PE than ED 6, 7. A combination of physiological and psychological factors are believed to influence the mechanism of ejaculation 8, 9. Men with PE appear to go through the same process of ejaculation as other men, but it happens more quickly and with a reduced feeling of control 6. Research suggests serotonin plays a central role in the timing of ejaculation 8-10. About dapoxetine ALZA Corporation, a Janssen-Cilag affiliate, licensed dapoxetine from PPD-GenuPro in 2001 with exclusive worldwide rights to develop and commercialise the compound for urogenital therapies, including premature ejaculation.The clinical trial programme for the use of dapoxetine in premature ejaculation was conducted by Johnson & Johnson Pharmaceutical Research and Development. The product will be marketed by Janssen-Cilag in most countries where regulatory approval has been granted. Product Availability After approval in a specific country, Priligy (dapoxetine) will only be available by prescription from a healthcare professional.The product is expected to be made available for purchase in licensed pharmacies in the countries where approved around April 2009, after all local regulatory requirements related to packaging and pricing are finalised. Janssen-Cilag will provide official confirmation of the exact date of product availability in each individual country. Applications for marketing authorisation in other countries are under review. Unapproved imitations (counterfeit) of dapoxetine have been sold. Government officials from around the world have warned of the potential risks associated with counterfeit drugs, including the risk of death. As for any prescription medication, patients should buy Priligy (dapoxetine) only from a pharmacy that is officially licensed by government authorities. Patients should be especially cautious of internet pharmacies, as many of these are unlicensed. 【原产地英文商品名】Priligy 30mg x 6 pills
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通用名称：达泊西汀
化学名称：(S)-N,N-二甲基-3-(萘基-1-氧基)-苯丙氨基盐酸盐，
英文名称：(S)-N,N-dimethyl-3-(naphthalen-1-yloxy)-1-phenylpropan-1-amine hydrochloride
用途：达泊西汀(dapoxetine)作为一种新型快速的SSRI，半衰期短，属于选择性5-羟色胺再吸收抑制剂(SSRI)，用于治疗男性早泄和勃起功能障碍。
用法用量：每次60-100mg
特点：服用后由肠胃吸收，直接口服约20-30分钟起效; 作用时间持续数十天; 副作用小，检测不出，有轻微头痛、恶心等症状，但很快消失。
【药理作用】早泄是大脑性欲中心反应性过高所致，导致男性过早地射精。而大脑性欲中心存在5—羟色胺和多巴胺之类的化学物质，它们能传导强烈的射精冲动，而达泊西汀能干扰上述化学物质，达到延迟射精时间的目的。
【药代动力】本品口服吸收迅速，30～120min达血药峰值，1h内奏效。生物利用度约40%。食物能明显降低本品吸收速度、程度和作用的发生。本品在肝脏主要经CYP 3A4介导代谢为活性代谢物,约80%经粪便排泄，13%由尿排泄，在精液中排泄不到0.001%。母体药物和活性代谢物的半衰期均为2h。65岁以上老年男性、肝功能不全和肾功能严重损害病人，清除率降低。
【适应症】早泄,包括器质性早泄,心理性早泄,以及内分泌系统紊乱造成的早泄都有很好的疗效(由于长期早泄引起的勃起不坚,射精无力,射精无快感,勃起时间短).
【用法用量】房事前1小时口服，每次一粒，可不定日服用。
达泊 西 汀 常见的不良反应为恶心、腹泻、头晕和头痛。在1期临床试验中，恶心发生率最高，在60mg组达20%，有10%的患者中断试验，头晕为6.2%，腹泻为6.8%。单剂量3omg和6omg的不良反应发生率分别为26.2%和40.5%，多剂量分别为45.2%和40.5%，腹泻、恶心和头晕的出现dl比dg常见，ds的不良反应发生率与单剂量相似，多数是轻中度的不良反应。没有发现心血管系统、肝脏和血液系统等严重不良事件。