Innovus Pharmaceutical's Release Results Indicating Vesele® Achieves 58% Increase in Sexual Desire in Women
41% Average Increase in all Five Endpoints Evaluated
SAN DIEGO, CA, June 18, 2015 (Newswire.com) - 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, announced today that the Company’s top line results from its Vesele® U.S. human survey clinical use trial in women with low female sexual dysfunction accompanying endpoints including: 1/ desire; 2/ Lubrication; 3/frequency of sexual intercourse; and 4/ ability to be aroused. Endpoints assessed in this study were designed to assess Hypoactive Sexual Desire Disorder (“HSDD”).
In the study, the Company reported that 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.
About the VES-002 Use Survey Trial.
· Method: Scores were assessed at initiation of trial, midpoint and conclusion. A five‐ point satisfaction scale was used. Satisfaction was summarized by combining scores from the users’ Mostly Satisfied, Satisfied, and Very Satisfied responses. Dissatisfaction was summarized using results from Dissatisfied and Very Dissatisfied responses.
· Subjects: 40 patients completed the study in the United States.
· Age: Over 50% of participants who completed the trial were between the ages of 40‐59. Over 70% who completed the study were age 40 and older. This was true at the baseline of the study as well.
· Regimen: two capsules twice a day for a total of 16 weeks.
Pursuant to these results, the Company believes that the data indicate that Vesele® was very well tolerated with no serious adverse events reported. The only minor events reported by the clinical trial patients were dry mouth, which was resolved by their drinking 62oz of water daily and sleep disturbance if taken late afternoon.
Vesele® is a proprietary oral formulation of arginine and citrulline with the natural absorption enhancer Bioperine®. Vesele® was formulated to increase blood flow and nitric oxide production.
“We are thrilled about these results from the Vesele® study and the magnitude of the responses achieved by the users” said Dr. Bassam Damaj, President & Chief Executive Officer of Innovus Pharma. “To our knowledge, there are no approved products in the U.S. for HSDD. The closest product, we believe, is in late stage development by Sprout Pharmaceuticals and it is awaiting FDA approval. Hence, we believe the market is open for Vesele® to be successful in the U.S. for this indication,” continued Dr. Damaj.
About Vesele®
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.
For more information, go to www.innovuspharma.com, www.zestra.com; www.ejectdelay.com; www.myvesele.com; www.sensumplus.com; www.myadroferti.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, to successfully commercialize Vesele® and other products 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.
Contact:
Kevin Holmes
Chesapeake Group
Tel: 410.825-3930
