European Association of Urology (EAU), MILAN, March 27 /PRNewswire/ --
- Pivotal Efficacy Data Reinforced by Female Partners; Robust Safety Data Presented
New data presented for the first time today at EAU demonstrate the benefits for men with premature ejaculation (PE) and their partners when treated with dapoxetine, the first oral pharmaceutical treatment to be developed specifically for PE(1).
The multinational phase III clinical trial enrolled over one thousand men and their female partners from 22 countries (including 16 European countries, Israel, South Africa, Canada, Mexico, Brazil and Argentina) to measure improvement of sexual functioning while taking 30mg or 60mg of dapoxetine (taken 1 to 3 hours prior to intercourse) versus placebo. Previously reported data showed significant improvements in men with PE treated with dapoxetine 30mg and 60mg across all measures of PE versus placebo(2).
The data presented today from female partners reinforce the beneficial impact of dapoxetine treatment, demonstrating significant improvement in all four pre-defined endpoints for partners of men treated with dapoxetine 30mg or 60mg versus placebo over a 25-week period(1):
- Perception of the Man's control over ejaculation: At baseline, fewer than 5% of women reported that their perception of their partner's control was "good" or "very good". This percentage increased to 24.7% and 32.4% with dapoxetine 30mg and 60mg respectively (vs 14.5% with placebo; p<0.001).
- (Female) distress at timing of partner's ejaculation: More than 42% of women reported that they were "quite a bit" or "extremely" distressed by the timing of their partner's ejaculation at baseline. This decreased to 22.3% and 18.3% with dapoxetine 30mg and 60mg respectively (vs 29.5% with placebo; p<0.001).
- (Female) satisfaction with intercourse: At baseline, fewer than 15% of women reported "good" or "very good" satisfaction with sexual intercourse. This increased to 33.6% and 39.1% with dapoxetine 30mg and 60mg respectively (vs 19.4% with placebo, p<0.01).
- Interpersonal difficulty associated with partner's ejaculation: At baseline, 27.2%, 18.9% and 22.0% of women in the placebo, dapoxetine 30mg and 60mg groups respectively, reported "quite a bit" or "extremely" for the level of interpersonal difficulty associated with their partner's ejaculation. This decreased to 21.2%, 12.5% and 10.7% in the placebo, dapoxetine 30mg and 60mg groups respectively.
Importantly, these findings confirm results from a separate study investigating how PE affects female partners, which confirmed the significant impact in terms of lower perceived control over ejaculation, lower satisfaction with sexual intercourse, higher ejaculation-related personal distress and/or interpersonal difficulty in the relationship when compared with female partners of men without PE(3).
Professor Jacques Buvat, Director of the Centre d'Etude et de Traitement de la Pathologie de l'Appareil Reproducteur et de la Psychosomatique (CETPARP) in Lille, France and lead author from the phase III dapoxetine trial, commented on the results, "PE is caused by a combination of physiological and psychological factors, controlled by serotonin signals from the brain, which means that it may be treated with pharmacotherapy. By improving control during sex, dapoxetine has been shown to help men and their partners experience greater sexual satisfaction, and reduce interpersonal distress."
Results from two large, randomized, placebo-controlled trials presented at EAU demonstrated the safety of dapoxetine. The most common AEs included nausea, headache, dizziness, and diarrhoea. Most AEs were mild to moderate in severity and did not result in discontinuation from the study. Both trials showed that treatment with dapoxetine was not associated with the development of SSRI withdrawal syndrome (a constellation of symptoms including dizziness, gastrointestinal distress, flu-like symptoms, akathisia, sleep disturbances, anxiety, agitation, irritation, aggressive or impulsive behaviour, and others)(4), although the occurrence of generally mild withdrawal symptoms may occur. Both studies also confirmed that dapoxetine was not associated with any significant changes in sexual desire or mood (anxiety and depression)4, measured using validated scales for these effects.
Notes to Editors
About Premature Ejaculation
Premature ejaculation is believed to be the most common sexual medical disorder in men(5). The underlying pathophysiology of PE is not completely understood, although both physiological and psychological components could contribute to the condition. Unlike erectile dysfunction, PE has similar prevalence across age groups.
PE has been recognised by the European Society for Sexual Medicines (ESSM), the American Urological Association (AUA), the American Psychiatric Association (APA), the World Health Organisation (WHO) and the International Society for Sexual Medicine (ISSM). PE is defined by the International Society of Sexual Medicine as "a male sexual dysfunction characterized 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."(6)
It has a significant impact both on the man, his partner and their relationship, and can adversely affect self-image, interfere with sexual satisfaction and the sexual relationship, and negatively affect overall quality of life. A survey of more than 12,000 men found that those who are classified as having PE had significantly worse sexual functioning than men who are not classified as having PE, lower self-esteem, concern about the effect on the overall relationship - sometimes to the extent of avoiding relationships - and anxiety and embarrassment(7). According to the survey, men with PE also had lower levels of quality of life satisfaction and general state of health than men without PE. Partners are not only distressed by the quality of the man's sexual performance, but they are also upset because the man's associated distress often leads to a rapid and unwanted interruption of intimacy.
Despite the prevalence of PE, it remains highly under treated. Behavioural and cognitive therapies have shown initial success, but many patients do not maintain benefits over the long term, and PE typically returns.
In December 2007 Janssen-Cilag companies in Europe have submitted a Marketing Authorisation Application (MAA) for dapoxetine, a treatment for premature ejaculation (PE) in men 18-64 years of age. The MAA for dapoxetine was submitted under the decentralised procedure, in which Sweden will act as the Reference Member State and Austria, Finland, Germany, Italy, Portugal and Spain will act as the Concerned Member States for the application. The file was also submitted in Australia and New Zealand. Regulatory submissions in other regions of the world are expected to follow.
The Janssen-Cilag companies have a long track record in developing and marketing treatments for central nervous system disorders, pain management, oncology, infectious diseases, reproductive health and gastrointestinal disorders. More information about Janssen-Cilag can be found at http://www.janssen-cilag.com.
1. Buvat J et al. Improvement in Sexual Functioning of Female Partners of Men With Premature Ejaculation Treated With Dapoxetine. EAU 2008. Poster 464
2. Buvat J et al. Patient-reported treatment benefit of dapoxetine for the treatment of premature ejaculation in 22 countries. Poster presented at: the Winter Scientific Meeting of the Sexual Medicine Society of North America; 6-9 December 2007; Chicago, Illinois, USA
3. Porst H et al. Impact of Premature Ejaculation on Female Partners: Results from a 5-Country European Observational Study. EAU 2008. Poster 462
4. Giuliano F et al. Lack of discontinuation syndrome or effects on anxiety with dapoxetine for the treatment of premature ejaculation: results from 2 phase II trials. EAU 2008. Poster 465
5. American Urological Association. http://www.auanet.org. Accessed 05/03/08
6. International Society for Sexual Medicine. http://www.issm.info. Accessed 05/03/08
7. Johnson & Johnson Pharmaceutical Research and Development, Data on file
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