Abstract Number: PD69-02 Title: Double-Blind, Randomized Controlled Trial of Topical 4% Benzocaine Wipes for Management of Premature Ejaculation: Interim Analysis Date/Time: Tuesday, May 16, 9:40 a.m. to 9:50 a.m. Location: BCEC, Room 159 Speaker: Ridwan Shabsigh, M.D., Professor of Urology at Weill Cornell Medical College, and President of the International Society of Men's HealthPress Program
Title: Double-Blind, Randomized Controlled Trial of Topical 4% Benzocaine Wipes for Management of Premature Ejaculation: Interim Analysis Date: Saturday, May 13, 11:30 a.m. to 12 p.m. Location: BCEC, Room 109A Moderator: Dr. Tobias Kohler Speakers: Harry Fisch, M.D., Urologist; Chief Corporate Officer of The Female Health Company / Veru Healthcare.The abstract is based on interim analysis of an independent clinical study conducted by Jed Kaminetsky, M.D., Medical Director at Manhattan Medical Research, Clinical Assistant Professor of Urology at New York University Medical Center, and practicing urologist with University Urology Associates; Michael Yang, Clinical Research Coordinator at Manhattan Medical Research and University Urology Associates; Michael Perelman. M.D., Clinical Professor Emeritus of Psychology in Psychiatry at Weill Cornell Medical College; and, Ridwan Shabsigh, M.D., Professor of Urology at Weill Cornell Medical College, and President of the International Society of Men's Health.
About Premature Ejaculation (PE):PE is defined by the International Society for Sexual Medicine as, persistent or recurrent ejaculation with minimal sexual stimulation before, on, or shortly after penetration and before the person wishes it. PE is the most common sexual dysfunction, even more common than erectile dysfunction, according to numerous epidemiological studies. It is a problem for couples and the most commonly observed sexual disorder in men below 40 years of age. PE is a self-reported diagnosis with a prevalence rate of 20-30 percent. The estimated prevalence of PE is 50 million men in the US and 60 million men in Europe. Total worldwide market for premature ejaculation drugs and consumer health care products is estimated to be greater than $500 million annually.About PREBOOST ® :PREBOOST ® is a new, proprietary OTC male genital desensitizer used for the treatment of PE. There are no prescription products for PE approved by the United States FDA. Off label use of antidepressants and PDE-5 inhibitors have been used with limited success because of inconsistent efficacy and unacceptable side effects. Psychological counseling and behavioral therapy are also used with mixed results. Of the consumer health products, the topical anesthetics are administered as sprays and gels. The drawbacks of these approaches include inconsistent dosing leading to too much anesthetic and transference of the anesthetics to the partner. PREBOOST ® is compliant with the FDA monograph and is approved in the United States. PREBOOST ® is the only individually packaged medicated wipe that contains a desensitizing agent (benzocaine 4.0%). The advantages are: 1) Convenient individually wrapped wipes so it is easier to carry and to be discreet, 2) The correct dose is delivered each time 3) The medicine is applied topically and dries quickly which prevents the potential for transference to partner, and 4) Benzocaine at 4.0% temporarily desensitizes, but does not numb the penis. PREBOOST is currently available in the US and can be purchased at www.PREBOOST.com. About The Female Health Company / Veru HealthcareThe Female Health Company / Veru Healthcare is a pharmaceutical and medical device company, with a focus on the development and commercialization of pharmaceuticals that qualify for the FDA's 505(b)(2) accelerated regulatory approval pathway as well as the 505(b)(1) pathway. The Company does business both as "Veru Healthcare" and as "The Female Health Company" and is organized as follows:
- Veru Healthcare manages the Pharmaceuticals Division, which develops and commercializes pharmaceutical products for men's and women's health and oncology.
- Veru Healthcare manages the Consumer Health / Medical Devices Division, which is focused on commercializing sexual healthcare products and devices for the consumer market, including the Company's FC2 Female Condom ® (now available by prescription) and PREBOOST ® medicated individual wipe, which is a male genital desensitizing drug product that helps in the prevention of premature ejaculation.
- The Female Health Company manages the Global Public Health Division, which is focused on the global public health sector FC2 business. This division markets the Company's Female Condom (FC2) to entities, including ministries of health, government health agencies, U.N. agencies, nonprofit organizations and commercial partners, that work to support and improve the lives, health and well-being of women around the world.
Contact:Kevin Gilbert: 312-366-2633