MIAMI--(BUSINESS WIRE)--Veru Healthcare (NASDAQ:FHCO) today announced positive results from a Phase 4 clinical study of its proprietary product PREBOOST (topical 4% benzocaine wipes) for the management of premature ejaculation (PE). Data showed that PREBOOST wipes statistically and significantly improved both objective and subjective symptoms of PE when compared to placebo wipes. Results were selected for inclusion in the American Urological Association’s (AUA) Annual Meeting Press Conference, held this morning in Boston. The data will also be shared during a podium presentation on Tuesday, May 16, 2017.
“Premature ejaculation or PE is the most common sexual dysfunction, affecting one in four men, yet we have limited options that really help men manage it,” said study investigator and presenter Ridwan Shabsigh, MD, Chairman of Surgery, SBH Health System, Bronx and Professor of Clinical Urology at Weill-Cornell Medical School, New York. “These data represent the first ever placebo-controlled clinical study of medicines available in this class of products. This Phase 4 clinical study shows that over-the-counter PREBOOST benzocaine wipes allow men to delay ejaculation on average five minutes longer, which is exciting considering the negative impact PE can have on men and on their relationships.”
The Phase 4 double-blind, randomized, placebo-controlled clinical study met its primary endpoint of change in average Intravaginal Ejaculatory Latency Time (IELT) at two months, as well as secondary outcomes of change in questionnaire assessments including global rating of distress, medication assessment and Index of Premature Ejaculation (IPE). After treatment with PREBOOST, 82 percent of men were no longer considered to have PE while being treated and reported a statistically significant better sense of ejaculation control, confidence, satisfaction, sexual pleasure, increased length of intercourse and reduced frustration. Treatment was well tolerated and no transference of product was reported.
“We’re excited about these clinical data and what our product can do for men who have really had no options and desire a simple solution to PE,” said Mitchell Steiner, MD, President and Chief Executive Officer, Veru Healthcare. “These Phase 4 data represent the first clinical study ever to show clinical data of an OTC product for the management of premature ejaculation.”
The product was created and is being developed by company cofounder and practicing urologist Harry Fisch, MD, largely in response to a need he saw with his patients.
Study investigator Dr. Ridwan Shabsigh will present the full clinical results of Double-Blind, Randomized Controlled Trial of Topical 4% Benzocaine Wipes for Management of Premature Ejaculation, abstract PD69-02, during a podium presentation at the AUA annual meeting from 9:40 am – 9:50 am EST on Tuesday, May 16, Boston Convention and Exhibition Center, Room 159. Final results of the clinical study will also be presented.
The study enrolled 26 men aged 18 years or older in a heterosexual, monogamous relationship, with PE, defined as reported poor control over ejaculation, personal distress related to ejaculation and average intravaginal ejaculatory latency of two minutes or less on stopwatch measurement. Subjects were randomized 2:1 to treatment with benzocaine wipes or placebo wipes, with men in the placebo group crossed over to the treatment group one month after randomization.
The primary outcome measure for the study was change in IELT at two months, with secondary outcomes including change in questionnaire assessments of global rating of distress, medication assessment and Index of Premature Ejaculation (IPE). A Wilcoxon rank-sum test was utilized for all comparison outcomes.
The analysis was conducted in 26 men who were randomized (17 treatment, 9 placebo) and had complete follow-up data. Data showed that patients treated with benzocaine 4% wipes demonstrated a statistically significant improvement in IELT after the first month of treatment (2.75 minutes), with greater improvement after the second month (5.5 minutes), compared to placebo (1.8 minutes). Men in the treatment group also reported greater improvement in distress relating to intercourse, control of ejaculation and satisfaction with sexual intercourse over the study period.
Results showed that treatment was well tolerated. Two treated men experienced adverse events, including mild headache and back pain and mild irritation on the penis, which resolved spontaneously.
Funding for the study was provided by Veru Healthcare/The Female Health Company.
About Premature Ejaculation
According to the International Society for Sexual Medicine (ISSM), premature ejaculation (PE) is the most common sexual dysfunction in men, even more common than erectile dysfunction. The ISSM defines PE as persistent or recurrent ejaculation with minimal sexual stimulation before, on, or shortly after penetration and before the person wishes it to happen. Estimates of prevalence range significantly; however, most experts estimate the prevalence rate at 20-30 percent of men, as it can affect men of all ages. The condition is especially debilitating because many men who suffer from PE also report a significant impact on partners and relationships.
PREBOOST is a proprietary OTC male genital desensitizer used for the treatment of PE. The product is an individually packaged medicated wipe (benzocaine 4%) designed to be discreet and easy to carry. The medicine is applied topically to the penis and dries quickly, temporarily desensitizing the penis without numbing it. There are no prescription treatments approved by the U.S. Food and Drug Administration (FDA) for the treatment of premature ejaculation. Currently available over-the-counter sprays and gels create challenges with dosing and potential transference of product to the partner. PREBOOST is compliant with the relevant FDA monograph and is available for sale in the U.S. at www.PREBOOST.com.
About Veru Healthcare
Veru Healthcare/The Female Health Company is a pharmaceutical and a medical device company that develops and manufactures products for men’s and women’s health and oncology, including the FC2 Female Condom® now available by prescription in the U.S. The Female Health Company division exclusively markets the FC2® into global public health sector markets. For more information about the company and its products, visit https://veruhealthcare.com.