The Female Health Company / Veru Healthcare Reports Interim Analysis Of Independent Placebo Controlled Clinical Study Of PREBOOST®, Its Proprietary Premature Ejaculation Medication

MIAMI, Nov. 17, 2016 (GLOBE NEWSWIRE) -- The Female Health Company / Veru Healthcare (NASDAQ:FHCO) today announced top line interim analysis of an independent, double-blind, randomized, controlled clinical study of the company's novel PREBOOST ® product (topical 4% benzocaine wipes) for the management of premature ejaculation (PE).  The scientific abstract that describes the full interim analysis results has been submitted to a major urological medical conference.  The company plans to launch PREBOOST ® in the US before year-end.

The independent clinical study was 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.  The clinical study was supported by Veru Healthcare.

The top line results of the interim analysis from 21 men show:
  • After two months, men treated with PREBOOST ® had statistically significant improvement in their ability to control ejaculation, with a mean increase in duration of almost four minutes, which was significantly greater than men on placebo.  After treatment with PREBOOST, 80% of men were no longer considered to have PE;
  • Men treated with PREBOOST ® reported a statistically significant better sense of ejaculation control, confidence, satisfaction, sexual pleasure, length of intercourse and reduced frustration;
  • PREBOOST ® was well tolerated and no transference was reported;
  • The interim clinical study met the primary endpoint of change in average intravaginal ejaculatory latency time (IELT) at two months and secondary outcomes of change in questionnaire assessments, such as global rating of distress, medication assessment, and Index of Premature Ejaculation (IPE).

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