New drug increases intercourse time by 6-fold; delays orgasm: Sciele

A spray treatment which can prolong intercourse time by at least six-fold by delaying orgasm in prematurely ejaculating men has been developed by a Japanese company Shionogi unit Sciele Pharma Inc.

The investigational drug code-named PSD502 combines two local anesthetics – lidocaine and prilocaine – in an aerosol applied to the tip of the penis.

Final stage clinical trial data shows that the spray drug PSD502 delayed orgasm by an average of 108 seconds.

The study involved patients from the USA, Canada and Europe.

The Phase III study was a multi-centre, randomised, double blind, placebo-controlled efficacy study that recruited a total of 540 patients across the two studies.

Patients were treated for a 12-week period with an optional open-label phase of up to nine months.

Analyses of the data show that PSD502 produced a highly clinically and statistically significant increase from baseline in all co-primary study endpoints.

PSD502 increased the intra-vaginal ejaculation latency time (IELT) at least six-fold with PSD502 when compared to baseline.

Patients took PSD502, took an average of 2.6 minutes to reach ejaculation, compared with 0.8 minute for those given a placebo.

There was a five-point difference between PSD502 and placebo in the IPE domains for ejaculatory control and sexual satisfaction, where a two-point difference is considered clinically significant.

There was a 2.5-point difference between PSD502 and placebo in the IPE domain for Distress  where a two-point difference is considered clinically significant.

As a secondary endpoint, partner satisfaction was also found to be considerably greater with PSD502 than placebo.

The incidence of serious adverse events and overall side effects was similar in the PSD502 and placebo group. Overall, PSD502 was well tolerated and there were no systemic adverse events. As previously reported, a very low incidence of mild penile numbing was observed.

“These are highly clinically significant results that show PSD502 is likely to be of considerable benefit to both patient and partner. Particularly pleasing is the ability to take the product on demand,” commented Dr. Ira Sharlip, Clinical Professor of Urology at the University of California at San Francisco and Past-President of the International Society of Sexual Medicine in a company statement.

The rapid onset of action of just five minutes is one of its most attractive characteristics which could be helpful in a big way for men suffering from premature ejaculation, Dr Sharlip added.

Premature ejaculation affects between 25% and 30% of men in the USA and Europe.

There is no effective therapy for premature ejaculation.One current treatment for premature ejaculation consists of topical creams with desensitizing agents which dull the penile skin and delay ejaculation. These creams require use of a condom and/or washing the cream away before intercourse and they may reduce sexual pleasure.

The previously announced Phase III study was conducted entirely in Europe, and its successful outcome was reported in November 2008.

Data from the two studies will be combined for submission for regulatory approval in the USA and Europe.

If approved, the drug would be the first prescription treatment in the United States for premature ejaculation.

Johnson & Johnson said in February that it won approval in Sweden and Finland for the first prescription pill to treat. However, US FDA rejected the drug three years later.

It aims to treat a sexual dysfunction affecting as many as a third of American men aged 18 to 59 years, Shionogi’s Sciele Pharma Inc. unit said in a statement.

In May 2007, Plethora signed an exclusive license agreement with Sciele Pharma, Inc.,  to market PSD502 for premature ejaculation in the USA.In May 2009 Sciele acquired global rights to the product.

Sciele plans to submit the treatment for regulatory review in the first half of 2010.

Sciele Pharma, Inc., a Shionogi Company, is a pharmaceutical company specializing in sales, marketing and development of branded prescription products focused on the therapeutic areas of Cardiovascular, Diabetes, Women’s Health and Pediatrics.

Headquartered in Atlanta, Georgia, Sciele’s  cardiovascular and diabetes products treat patients with high cholesterol, hypertension, high triglycerides, unstable angina and Type 2 diabetes; its Women’s Health products are designed to improve the health and well-being of women and mothers and their babies; and its Pediatrics products treat allergies, asthma, coughs and colds, and attention deficit and hyperactivity disorder (ADHD).

Shionogi & Co., Ltd., headquartered in Osaka, Japan, is a major research-driven pharmaceutical company dedicated to placing the highest value on patients. Shionogi’s Research and Development currently targets three therapeutic areas: Infectious Diseases, Pain, and Metabolic Syndrome.

Plethora is focused on the development and marketing of products for the treatment of urological disorders. Plethora has products in clinical development for the treatment of overactive bladder (PSD506), stress urinary incontinence (PSD503), interstitial cystitis (PSD597), gynaecological pain (PSD508), erectile dysfunction (PSD510) and premature ejaculation (PSD502). Plethora is headquartered in the UK.