SAN DIEGO, CA / ACCESSWIRE / July 1, 2015 / Innovus Pharmaceuticals, Inc., ("Innovus Pharma" or the "Company") www.innovuspharma.com (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 4th U. S. Food and Drug Administration's ("FDA") Advisory Committee's recommendation for the approval of flibanserinas 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(R), 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(R) 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(R) and another of its products, Zestra(R),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 of Sex & Marital Therapy established that Zestra(R) significantly improves a woman's desire, arousal and sexual satisfaction: 70% of women reported improved sexual satisfaction over multiple uses of the product.
About Zestra(R)
The Company believes that Zestra(R) 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(R) 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(R) Quantitative Consumer Study," October 2009, 43% of women have sexual difficulties as compared to about 31% of men who have ED (a market size close to $6B worldwide).