The Veru prostate cancer pipeline includes VERU-111, VERU-100, and Zuclomiphene citrate. is an oncology and urology biopharmaceutical company with a focus on developing novel medicines for the management of prostate cancer. Results showed that treatment was well tolerated. 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. 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) 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). 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 PREBOOST Clinical 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 Time (IELT) of two minutes or less on stopwatch measurement. The advantages are: 1) Convenient individually wrapped wipes so it is easier to carry and to be discreet, 2) The correct dose is provided each time and 3) The medicine is applied topically and dries quickly which lowers the potential for transference to a partner. PREBOOST is compliant with the FDA monograph and is an individually packaged medicated wipe that contains a desensitizing agent (benzocaine 4.0%). The drawbacks of many of these approaches include inconsistent dosing leading to too much anesthetic and transference of the anesthetics to the partner. Of the consumer health products, the topical anesthetics are administered as sprays and gels. Psychological counseling and behavioral therapy are also used with mixed results. Off-label use of antidepressants and PDE-5 inhibitors have been used with limited success because of inconsistent efficacy and unacceptable side effects. There are no prescription products for PE approved by the U.S. PREBOOST is a proprietary OTC male genital desensitizer used for the treatment of PE. The condition is especially debilitating because many men who suffer from PE also report a significant impact on partners and relationships.Ībout PREBOOST ® / Roman Swipes (4% benzocaine wipes) 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 and it is the most commonly observed sexual disorder in men below 40 years of age. 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. “We value our association with the leading men’s digital health clinic and our ability to increase patient access to this important medical product.”Īccording to the International Society for Sexual Medicine (ISSM), PE is the most common sexual dysfunction in men, even more common than erectile dysfunction. “We are pleased to extend our mutually successful partnership with Roman to provide a compelling, convenient and clinically-backed treatment for the many men who suffer from premature ejaculation,” said Mitchell Steiner, MD, Chairman, President and Chief Executive Officer of Veru Inc. This multi-million unit extension agreement extends the current three-year agreement for three more years. Roman successfully introduced Roman Swipes in mid-2018, which has seen rapid growth since its introduction. Roman has established itself as a leader in men’s digital health treatment, that brings the care of leading medical experts to the privacy of one's home. digital health distribution of the Company’s PREBOOST ®(4% benzocaine wipes) for the prevention of premature ejaculation (PE) under the Roman Swipes brand name. (NASDAQ: VERU), an oncology and urology biopharmaceutical company with a focus on developing novel medicines for the management of prostate cancer and which uses profits from its sexual health business to help fund its biopharmaceutical clinical development programs, today announced that it has signed a three-year multi-million unit extension agreement with Roman, the digital men's health clinic, for Roman’s exclusive U.S. Roman Swipes Seeing Rapid Growth through Leading Men’s Digital Health Clinic. Three-Year Multi-Million Unit Extension Agreement –
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