San Diego, CA, (UPTICK Newswire – July 1, 2015) –Innovus Pharmaceuticals, Inc., (“Innovus Pharma” or the “Company) www.innovuspharma.com (OTCQB: INNV) a company focusing on the commercialization of over-the-counter (“OTC”) and consumer products for men’s and women’s health, vitality and respiratory diseases, applauds the June 4thU. S. Food and Drug Administration’s (“FDA”) Advisory Committee’s recommendation for the approval offlibanserinas an important step forward in women’s health, as the decision addresses the important need for the women living with hypoactive sexual desire disorder (“HSDD”), to have an approved treatment option.
HSDD, is a subset of Female Sexual Dysfunction (FSD) along with Female Sexual Interest/Arousal Disorder (FSI/AD) is a medical condition marked by a lack of sexual thoughts and desire for sexual activity and cannot be accounted for by another medical physical or psychiatric condition or a substance-like medication. It is estimated that one in 10 women may have the signs of HSDD at some point in their life, and as such HSDD represents a major opportunity to address a tremendous medical need with therapies like flibanserin and consumer care products such as the Company’s product Vesele®, shlown in a use survey study in the US to help women cope with some aspects of this condition. In this survey study the use of Vesele® use resulted in the following:
1. 58% increase desire;
2. 40% increase in lubrication;
3. 34.2% increase in the frequency of sexual intercourse;
4. 45.9% increase in the ability to be aroused; and
5. 41% increase in overall satisfaction.
Innovus Pharma currently markets Vesele® and another of its products, Zestra®,as a hormone-free essential oil blend clinically validated in two U.S. placebo controlled double-blind trials in 278 women suffering from Female Sexual Interest/Arousal Disorder (“FSI/AD”), the largest subset of women with Female Sexual Dysfunction (FSD). The two clinical trials are published in the Journal ofSex & Marital Therapy established that Zestra® significantly improves a woman’s desire, arousal and sexual satisfaction: 70% of women reported improved sexual satisfaction over multiple uses of the product.
The Company believes that Zestra® is the only OTC natural product clinically proven in two U.S. double-blind, placebo controlled trials in 276 women to increase arousal, desire and reduce pain during sexual intercourse. Zestra® is currently commercialized in the U.S. and the United Kingdom by the Company and in Canada by the Company’s licensing partner,Orimed Pharma Inc., a subsidiary of Jamp Pharma, in Morocco and the United Arab Emirates (“UAE”) by Sothema Laboratories and has sold millions of units since its launch in 2007. According to Laumann, E.O. et al.,“Sexual Dysfunction in the United States: Prevalence and Predictors”, JAMA, Feb. 10, 1999. vol. 281, No. 6.537-542 and deKadt,“Zestra® Quantitative Consumer Study”, October 2009, 43% of women have sexual difficulties as compared to ~31% of men who have erectile dysfunction (a market size close to $6B worldwide).
Vesele® is a proprietary, novel oral dietary supplement to maximize nitric oxide’s beneficial effects on sexual function and brain health. Vesele® contains a patented formulation of L-Arginine and L-Citrulline, in combination with the natural absorption enhancer Bioperine®.
About Innovus Pharmaceuticals, Inc.
Headquartered in San Diego, Innovus Pharma is an emerging leader in OTC and consumer products for men’s and women’s health and vitality. The Company generates revenues from its lead products Zestra® for female arousal and EjectDelay® for premature ejaculation and has a total of five marketed products in this space, including Sensum+® for the indication of reduced penile sensitivity, (for sales outside the U.S. only), Zestra Glide®, Vesele® for promoting sexual and cognitive health, Androferti® (in the US and Canada) to support overall male reproductive health and sperm quality and hopefully, eventually from FlutiCare™ OTC for Allergic Rhinitis for which an ANDA has been submitted to the U.S. Food and Drug Administration.
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, receivingapproval or to be compliant with the requirements of any relevant regulatory authority, to successfully commercialize its products such as Vesele® and Zestra® and to achieve its other development, commercialization, financial and staffing objectives.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.
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