SAN DIEGO, May 15, 2014 (GLOBE NEWSWIRE) -- Innovus Pharmaceuticals, Inc., ("Innovus Pharma" or the "Company") www.innovuspharma.com (OTCBB:INNV) today announced that patient enrollment has begun in its EjectDelay™ post-marketing clinical study in Lebanon. The study is being run at the Lebanese-Canadian Hospital in Beirut, Lebanon.
EjectDelay's™ active ingredient is a proprietary fast absorbing and vanishing gel formulation with the active drug benzocaine at 7.5% designed to reduce transfer to the partner.
The study is a placebo-controlled, parallel, double-blind study for 12 weeks of treatment. The study will enroll a total of 50 patients. The primary endpoint of the study is the evaluation of the Intra-Vaginal Ejaculatory Time (I-ELT) achieved by the product in patients with premature ejaculation in this Middle Eastern population and the effect of the product on the female partner.
The Middle East and North Africa ("MENA") market is a large market for these two indications (premature ejaculation and reduced penile sensitivity) and the two studies, once successfully completed, will be the first controlled data to be reported in such a patient population.
"To our knowledge, EjectDelay™ is currently the only known benzocaine-based topical product clinically evaluated for premature ejaculation. We believe that this second study, if successful, will re-enforce our first clinical study, which has demonstrated the efficacy of the product in significantly delaying premature ejaculation and gives it the clinical edge to be recommended by many urologists for this indication," said Dr. Bassam Damaj, the President & Chief Executive Officer of the Company.
About EjectDelay™ and Premature Ejaculation
EjectDelay™ is an over-the-counter ("OTC") U.S. Food and Drug Administration-compliant proprietary topical treatment containing the drug benzocaine and indicated for delay of premature ejaculation. The drug typically works within minutes of application to the glans of the penis. In clinical trials, the application of benzocaine has been shown to delay premature ejaculation by several minutes. For more information visit www.ejectdelay.com.
Premature ejaculation ("PE") is the most common sexual dysfunction reported by men but is still under-diagnosed and under-treated. PE can happen at any age and its prevalence is consistent across all ages. In an article in The Journal of Sexual Medicine in 2007 Sex Med 2007, D.L. Patrick, D. Rowland and M. Rothman state, "Global studies consistently report that 20-30% of men experience PE worldwide. This means that PE is experienced at similar rates across the globe."
About Innovus Pharmaceuticals, Inc.
Headquartered in San Diego, Innovus Pharma is an emerging leader in the OTC male and female sexual dysfunction products. The Company generates revenues from its lead products Zestra® for female arousal, and EjectDelay™ for premature ejaculation, and has a total of four marketed products in this space including CIRCUMSerum™ (for sales outside the U.S. only) and Zestra® Glide.
For more information, go to www.innovuspharma.com.
INNOVUS PHARMA'S FORWARD-LOOKING Safe Harbor
Statements under the Private Securities Litigation Reform Act, as amended: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risks and uncertainties that may individually or mutually impact the matters herein described for a variety of reasons that are outside the control of the Company, including, but not limited to, receiving patent protection for any of its products, receiving approval or to be compliant with the requirements of any relevant regulatory authority relating to such products, to successfully commence a second clinical trial for and commercialize such products as EjectDelayTM and to achieve its other development, commercialization and financial objectives. Even if this clinical study with the Lebanese-Canadian Hospital is successful, there is no guarantee that the Company will be able to make money on its sales of both products. Readers are cautioned not to place undue reliance on these forward-looking statements as actual results could differ materially from the forward-looking statements contained herein. Readers are urged to read the risk factors set forth in the Company's most recent annual report on Form 10-K, subsequent quarterly reports filed on Form 10-Q and other filings made with the SEC. Copies of these reports are available from the SEC's website or without charge from the Company.