A study has found that freezing penile tissue causes a block for the nerves, enabling them to triple the length of duration, before ejaculation occurs. They tried the procedure on 24 men who hadn’t been helped by other treatments and medications, such as Viagra and Cialis, which are widely used for erectile dysfunction. Before the treatment the average time was 38 seconds prior to ejaculation, extended with the nerve block to 110 seconds. This would be the same result that you would expect with normal drug treatment.

With up to 38% of men being affected by premature ejaculation, it makes it the most frequent erectile dysfunction problem worldwide. Many treatments are available at present in tablet form, ointments and counselling.

The new procedure is an invasive treatment, by inserting a hollow needle just under the navel and being assisted by a computerised imaging device. They find one of the two dorsal penile nerves and freeze it, this is reported to not be of any discomfort, just a cold feeling. It takes about 45 minutes to perform and the patient is released from the clinic the same day, with an estimated cost when approved, of £2000.

As yet the recipients of the treatment, have not suffered any side effects. Although some did, 3 months post treatment, seemed to be experiencing ejaculating time shortening again. Bringing into question if it would have to be regularly administered, some test subjects are being monitored for more than 6 months.

It was asked at the conference as to how often you could repeat the treatment before damage occurred. Dr Prologo didn’t think there would be a long term problems as only one of the nerves will be destroyed. This is why another procedure is also under research using heat, which would not damage the nerve.

The results and new technique were revealed by J David Prologo MD, a professor of interventional radiology at Case Western Reserve University, in Cleveland and presented to the annual meeting of the Radiological Society of North America. Exponents’ of this procedure say that it could become a common treatment of dealing with this problem. As this work is in the early stages, other experts are sceptical of the future effects of the therapy and if men would take up the treatment.

At this time researchers are in the planning stages as to continued studies using a greater number of men for both procedures and also use of a placebo test.

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
Dapoxetine will be marketed by Janssen-Cilag, marking another significant advance in the company’s commitment to developing innovative, high quality treatments for unmet medical needs..

“Dapoxetine is an important new medication for doctors and patients,” commented Professor Dr Hartmut Porst, Private Institute for Urology and Andrology, Hamburg, Germany. “The lack of a previously approved oral medication for PE has contributed to a substantial deficiency in the diagnosis and treatment of this common condition. For the first time, physicians will be able to provide men with a pharmaceutical product that has been specifically developed for PE and that is proven to be effective.”

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.

About Janssen-Cilag

The Janssen-Cilag companies are part of the Johnson Johnson family of companies. They 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 www.janssen-cilag.com.

Johnson Johnson Pharmaceutical Research Development, L.L.C. (JJPRD)

JJPRD is part of the Johnson Johnson family of companies. JJPRD is headquartered in Raritan, NJ, and has facilities throughout Asia, Europe and the United States. JJPRD is leveraging drug discovery and drug development in a variety of therapeutic areas to address unmet medical needs worldwide.

Professor Dr Hartmut Porst has been a consultant and served on advisory boards for Janssen-Cilag.

IR Contacts:

Lesley Fishman: +1 732 524-3922
Louise Mehrotra: +1 732 524-6491

Media Contacts:

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Juhana Idänpään-Heikkilä: + 358 207 531 300
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Katarina Hamnström: +46 730 668 415
US:

Greg Panico +1 908 927-3715

(This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialise, actual results could vary materially from Janssen-Cilag’s expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson Johnson’s Annual Report on Form 10-K for the fiscal year ended December 31, 2007. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson Johnson. Janssen-Cilag does not undertake to update any forward-looking statements as a result of new information or future events or developments.)

REFERENCES

¹ Buvat, J., et al., Abstracts of the Sexual Medicine Society of North America, SMSNA, 2007 Winter Meeting. December 6-9, 2007. Chicago, Illinois. Patient-reported Treatment Benefit of Dapoxetine for the Treatment of Premature Ejaculation in 22 Countries. J Sex Med 2008. 5(Suppl 1): p. 4-41

² Pryor, J.L., et al., Efficacy and tolerability of dapoxetine in treatment of premature ejaculation: an integrated analysis of two double-blind, randomised controlled trials. Lancet, 2006. 368(9539): p. 929-37

³ McMahon, C., et al., Abstract of the joint congresses of the European and International Societies of Sexual Medicine December 7–11 2008, Brussels, Belgium. Efficacy and Safety of Dapoxetine for Premature Ejaculation: Integrated Analysis of 5 Phase 3 Trials. J Sex Med, 2009. in press

⁴ Grenier, G. and E.S. Byers, The relationships among ejaculatory control, ejaculatory latency, and attempts to prolong heterosexual intercourse. Arch Sex Behav, 1997. 26(1): p. 27-47.

⁵ McMahon, C.G., et al., An evidence-based definition of lifelong premature ejaculation: report of the International Society for Sexual Medicine Ad Hoc Committee for the Definition of Premature Ejaculation. BJU Int, 2008.

⁶ Porst, H., et al., The Premature Ejaculation Prevalence and Attitudes (PEPA) survey: prevalence, comorbidities, and professional help-seeking. Eur Urol, 2007. 51(3): p. 816-23; discussion 824.

⁷ Laumann, E.O., A. Paik, and R.C. Rosen, Sexual dysfunction in the United States: prevalence and predictors. Jama, 1999. 281(6): p. 537-44.

⁸ Donatucci, C.F., Etiology of ejaculation and pathophysiology of premature ejaculation. J Sex Med, 2006. 3 Suppl 4: p. 303-8.

⁹ Wolters, J.P. and W.J. Hellstrom, Current concepts in ejaculatory dysfunction. Rev Urol, 2006. 8 (Suppl 4): p. S18-25.

¹⁰ Palmer, N.R. and B.G. Stuckey, Premature ejaculation: a clinical update. Med J Aust, 2008. 188(11): p. 662-6.

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