News Release

Who wants to talk about premature ejaculation?

This release is being distributed on behalf of Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Peer-Reviewed Publication

Hill and Knowlton

SAN FRANCISCO, May 10 -- It is one of man's most common, underestimated sexual problems: Ejaculating earlier than desired. More common than erectile dysfunction, this condition can affect men at any point in their lives, and one in four men experience poor control over ejaculation on a frequent basis. According to published research, 20%-30% of men worldwide are commonly affected by premature ejaculation (PE), yet this medical condition remains a taboo subject in virtually every culture. Two presentations at this week's 99th Annual Meeting of the American Urological Association (AUA) are helping to increase understanding and discussion of this common male sexual condition.

"Premature ejaculation is a frequent and distinct medical condition that can severely impact quality of life, affecting the physical and emotional well-being of patients and their partners," says James H. Barada, M.D., urologist at the Center for Male Sexual Health, Albany, NY, and board member of the Sexual Medicine Society of North America (SMSNA). "But most men are reluctant to talk about it with their partners or physicians."

To address whether renaming the condition would help increase awareness of, and discussion about, premature ejaculation, and reduce the stigma associated with it, the SMSNA has established a Scientific Working Group. The working group undertook a review of recent research and a representative research study, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. At the AUA, Dr. Barada presented the recommendations of the working group. The working group found that the term premature ejaculation was universally recognized and accurately understood by men with the condition and their partners, and concluded that changing the name may have the opposite effect, resulting in confusion and requiring extensive re-education. In the research study, which included 61 healthcare professionals, 75 men with premature ejaculation and 48 partners, other terms that also were occasionally used by physicians to describe the condition like "rapid ejaculation", were not as well understood by the study participants.

Most significantly, the results of the study highlight that the stigma is not associated with the name, but with the condition. The SMSNA Scientific Working Group recommends continued use of the term premature ejaculation to describe the condition, and in a move to minimize the stigma, calls on medical professionals to encourage communication about sexual health and the medical causes of premature ejaculation.

Why is premature ejaculation so stigmatized considering it is a well-known condition?

Further research reported at the AUA by Andrew R. McCullough, M.D., Director of Male Sexual Health, Fertility and Microsurgery at the New York University Medical Center suggests that one of the reasons might be the broad impact that premature ejaculation has on many aspects of a man's life, leaving him with feelings of embarrassment and inadequacy. Dr. McCullough's analysis shows that men with poor control over ejaculation tend to be less satisfied with sexual intercourse and their sexual relationship, and may suffer more difficulties with sexual anxiety and arousal compared to non-sufferers (P < 0.01).

In the study, men classified with probable premature ejaculation self-reported poor control over ejaculation (50%), low satisfaction with sexual intercourse (23%), low satisfaction with sexual relationship (30%), low interest in actually having sexual intercourse (28%), difficulty in becoming sexually aroused (34%), and difficulty relaxing during intercourse (31%). These findings highlight the negative impact of premature ejaculation on quality of life, sexual performance and enjoyment of sex.

Dr. McCullough states: "Both presentations draw much needed attention to the prevalence and impact of premature ejaculation as well as the importance of open dialogue. These studies highlight that male sexual health encompasses less acknowledged medical conditions, beyond erectile dysfunction."

The McCullough study analyzed data collected from an on-line survey of 1,158 men above the age of 21 who were in stable (> 6 months) heterosexual relationships and answered 31 questions regarding overall and sexual health. These included questions about ejaculatory control that were primarily based on DSM-IV premature ejaculation criteria. According to these criteria, 32% of surveyed men identified themselves as sufferers, which is consistent with prevalence estimates in the literature. Of these, 189 men identified themselves as "probable" premature ejaculation sufferers, and a further 188 as "possible" sufferers.

Premature ejaculation is defined as persistent or recurrent ejaculation with minimal sexual stimulation before, upon, or shortly after penetration, or before the person wishes, causing distress and embarrassment to one or both partners, potentially affecting sexual relationships and overall well-being.

Johnson & Johnson Pharmaceutical Research & Development supported the SMSNA Scientific Working Group and the McCullough study.

ALZA Corporation obtained rights to develop and commercialize dapoxetine under an agreement among ALZA, Pharmaceutical Development, Inc. and GenuPro, Inc. in January 2001. Under the agreement ALZA acquired the right to develop and commercialize dapoxetine for urogenital indications, including premature ejaculation, on a worldwide basis.

ALZA and Johnson & Johnson Pharmaceutical Research & Development are developing dapoxetine and will seek approval from regulatory authorities around the world. Dapoxetine is currently undergoing Phase III clinical evaluation. Following successful regulatory approval, dapoxetine will be marketed by Ortho-McNeil Pharmaceutical, Inc. in the USA, Janssen-Ortho Inc. in Canada and by Janssen-Cilag companies around the world.

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