Over 40% Increase in all Six Endpoints Evaluated
SAN DIEGO, CA – (Eastside Business Newswire – June 20, 2015) – Innovus Pharmaceuticals, Inc., www.innovuspharma.com 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, recently announced that the Company’s top line results from its Vesele U.S.human survey use clinical trial in people with low erectile dysfunction accompanying endpoints including: 1/ erection hardness; 2/ erection maintenance; 3/frequency of sexual encounters; and 4/ desire for sexual encounters.
Vesele use resulted in the following:
- 5% increase in erection hardness
- 5% increase in erection maintenance
- 6% increase in desire for sexual activity
- 1% increase the ability to satisfy the partner
- 44% increase in overall satisfaction
About the VES-001 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 Mostly Satisfied, Satisfied, and Very Satisfied. Dissatisfaction was summarized using results from Dissatisfied and Very Dissatisfied.
- Subjects: 72 patients completed the trial in the United States.
- Age: Over 50% of participants who completed the trial were between the ages of 40‐ Over 70% were age 40 and older. This was true at baseline as well
- Regimen: two capsules twice a day for a total of 16 weeks
Pursuant to these clinical trials, the data indicate that Vesele was very well tolerated with no serious adverse events reported. The only minor events reported were dry mouth which resolved by 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 trial which we believe confirms that activity of the product and increase its commercial potential” said Dr. Bassam Damaj, President & CEO of the Innovus Pharma. “Erection hardness and maintenance is one of the main complaints of PDE5 drugs approved for erectile dysfunction and we see Vesele® as a great product to help with these complaints. Erectile dysfunction is a $5 billion dollar worldwide market that Innovus can tap into”, continued Dr. Damaj.
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 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.