Navigation Links
Pivotal data for the investigational treatment PSD502 for primary premature ejaculation
Date:5/31/2010

SAN FRANCISCO, CA/ATLANTA, GA, June 1, 2010 - Shionogi Pharma, Inc., a U.S.-based group company of Shionogi & Co., Ltd., today presented data summarizing the results of two pivotal studies of the investigational new drug PSD502, a topical metered dose spray being developed for the treatment of primary premature ejaculation (PE). These data were presented at the 2010 American Urological Association (AUA) Annual Meeting in San Francisco.

Evaluating a combined total of 556 (randomized) and 536 (treated) men with primary PE in the United States, Canada and Europe over a three-month period, with more than 23,000 exposures to PSD502 recorded, the data demonstrated that men who were treated with PSD502 five minutes before intercourse by applying PSD502 via a topical metered dose spray had a time to ejaculation 5.5 times longer than those who used a placebo spray with the actual average measurement in minutes for drug and placebo.

A co-primary endpoint also looked at ejaculatory control and satisfaction. Point differences of 6.1 and 5.3 were observed between the PSD502 group and placebo in ejaculatory control and satisfaction domains, respectively (p<0.0001 for all).

"Combined results from the PSD502 pivotal studies are very exciting and this is a significant milestone," said Ira D. Sharlip, MD, clinical trial investigator and clinical professor of urology at the University of California, San Francisco.

The exact incidence of PE is not known, as a widely accepted definition of PE has only recently become available. Depending on the definition used, ranges from 5% to more than 30% incidence of PE or ejaculatory control issues have been reported in the literature. For example, according to a large national study, approximately 30% of men suffer from ejaculatory control issues, including climaxing too early, while data from the National Health and Social Life Survey (NHSLS) states the prevalence as 21% in men ages 18 to 59 in the United States.

Pivotal Study Details

Men selected from 70 centers in the United States, Canada and Europe with primary PE and an Intravaginal Ejaculatory Latency Time (IELT) of less than one minute were randomly placed in one of two groups, two-thirds in the PSD502 group and one-third in the placebo group. Participants were instructed to apply PSD502 or placebo to the glans penis five minutes before intercourse. Efficacy was assessed from changes in IELT and in the domains of the Index of Premature Ejaculation (IPE), a patient reported outcome questionnaire, over a period of three months.

The baseline IELT in both study groups was less than 0.6 minutes which increased 5.5 fold and 1.6 fold in the PSD502 and placebo groups, respectively (p<0.0001), resulting in a mean IELT of 3.3 minutes in the PSD502 group. There were greater improvements in all domain scores of the IPE in the PSD502 group compared to placebo resulting in 6.1, 5.3 and 2.6 point differences between PSD502 and placebo in ejaculatory control, satisfaction and distress domains respectively (p<0.0001 for all).

In the PSD502 group, 6.1% of patients reported treatment-related adverse events versus 0.6% in the placebo group. There was one treatment-related adverse event greater than or equal to 3% (loss of erection; 3.1%). Almost 7 percent (6.7%) of partners reported adverse events compared to 1.7% in the placebo group. The most commonly reported adverse event in partners was vulvovaginal burning sensation (5%).

About Premature Ejaculation (PE)

For years, experts debated about the definition of premature ejaculation. In 2008, the International Society for Sexual Medicine presented an evidence-based definition of PE as agreed upon by a consensus of the world's leading sexual health experts: 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. Currently, there are no prescription therapies approved by the U.S. Food and Drug Administration to treat premature ejaculation.

About PSD502

PSD502 is a proprietary formulation of the two marketed drugs lidocaine and prilocaine dispensed as a topical metered dose spray that is currently under investigation for the treatment of primary premature ejaculation. PSD502 works primarily on non-keratinized skin on the mucosa of the glans penis.


'/>"/>

Contact: Dave Schemelia
dschemelia@healthstarpr.com
609-468-9325
HealthStar PR
Source:Eurekalert

Related medicine news :

1. Carfilzomib Safety Data From Ongoing Phase 2b Pivotal Trial in Relapsed and Refractory Multiple Myeloma Show Promising Safety and Tolerability
2. Dr. Jay Calvert MD Announces Details on New Patent-Protected Investigational Breast Implants
3. Cardiome Announces Investigational Candidate, Vernakalant, Meets Primary Endpoint in European Comparator Study
4. BHR Pharma Files Investigational New Drug Application, Receives Orphan Drug Designation, for Traumatic Brain Injury Treatment
5. Scott & White Healthcare researchers studying investigational agent that targets breast cancer
6. Steroids May Be Overrated in Treatment of COPD
7. Experimental stem cell treatment arrests acute lung injury in mice, study shows
8. Entest BioMedical Enters into LOI with Advanced Light Devices to Develop Laser Platform for Stem Cell / Laser COPD Treatment
9. New study shows effectiveness of MEND program in prevention and treatment of pediatric obesity
10. New York City Surgeon Develops All-Natural Treatment for Wrinkles and Scars
11. Novelty lures rats from cocaine-paired settings, hinting at new treatments for recovering addicts
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/2/2016)... ... May 02, 2016 , ... MedaCheck, a leading medication ... outcomes, has announced its partnership with GrandView Health Services. , With decades of ... counter and prescription drug pharmacy services to thousands of residents. Serving Indiana, Ohio, ...
(Date:5/2/2016)... TN (PRWEB) , ... May 02, 2016 , ... ... and behavioral health services, today announced the opening of Twin Lakes Recovery Center. ... will be Summit’s first in the state. The residential facility is set ...
(Date:5/1/2016)... (PRWEB) , ... May 01, 2016 , ... Women's Excellence ... Essential Oils and taught by Patti Dolan, a Young Living Gold Member. , The ... 6:30pm - 7:15pm followed by a small intro to the Oils that can benefit ...
(Date:4/30/2016)... (PRWEB) , ... May 01, 2016 , ... Serenity Recovery, ... to rehabilitation, has produced a new video that focuses on one of the more ... recent sessions and clips from interviews with a participating patients and the Yoga class ...
(Date:4/30/2016)... , ... April 30, 2016 , ... ... Boise, President and CEO of EMED, today signed a multifaceted agreement which will ... and the Northern Caribbean University Department of Natural and Applied Sciences, Allied Health ...
Breaking Medicine News(10 mins):
(Date:4/28/2016)... April 28, 2016  Marking its one year ... and ovarian cancer risk test, Color Genomics ... genes that highly impact the most common hereditary ... the Color Test analyzes hereditary cancer risks for ... uterine cancers. The Color Test is physician ordered ...
(Date:4/28/2016)... YORK , April 28, 2016 ... online consumer insights on healthcare, announced today that it ... their report Cool Vendor in Life Sciences, 2016, ... April 15, 2016.  The report focuses on life-science- oriented ... gain insight from patients and doctors, confirm medication ingestion, ...
(Date:4/28/2016)... April 28, 2016 Oramed Pharmaceuticals Inc. ... pharmaceutical company focused on the development of oral drug delivery ... upcoming PIONEERS 2016 conference, presented by Joseph Gunnar ... New York . Nadav Kidron , ... conference. Presentation Details:   PIONEERS ...
Breaking Medicine Technology: