Innovus Pharma Initiates Pre-Clinical and Clinical Program Evaluating the Safety and Efficacy of Vesele® with Sildenafil (Viagra®)

Studies Aimed at Quantifying Nitric Oxide Production and Erectile Dysfunction International Score (IIEF)

SAN DIEGO--()--Innovus Pharmaceuticals, Inc. ("Innovus Pharma") (OTCQB Venture Market: INNV), an emerging commercial stage pharmaceutical company delivering over-the-counter medicines and consumer care products for men’s and women's health and respiratory diseases, announced today the initiation of a pre-clinical and clinical program intended to evaluate the safety and efficacy of the combination of its supplement Vesele® for promoting sexual health with sildenafil indicated for treating erectile dysfunction. Sildenafil in the U.S. is sold under the name Viagra® by Pfizer, Inc. (“Pfizer”).

Vesele® is a proprietary oral formulation of L-Arginine and L-Citrulline with the natural absorption enhancer Bioperine®. Vesele® was formulated to increase blood flow and nitric oxide production.

As previously reported, the Company performed a U.S. human clinical survey to evaluate erectile dysfunction and sexual satisfaction in men using Vesele® twice daily for up to four months with the following favorable results:

1. 49.5% increase in erection hardness;
2. 44.5% increase in erection maintenance;
3. 34.6% increase in desire for sexual activity; and
4. 34.1% increase in the ability to satisfy the partner.

“Due to the positive results obtained on the erection hardness and maintenance in the clinical use survey with Vesele® and the complimentary mechanism of action of Vesele® on nitric oxide and blood flow, we believe it is only natural to evaluate the effects of the combination of both products on erectile dysfunction endpoints,” said Innovus CEO Dr. Bassam Damaj.

The open label, single arm study is designed to assess the safety and effect of concomitant use of Vesele® and sildenafil in men diagnosed with erectile dysfunction. The treatment consists of oral administration of Vesele® twice daily (BID) for four weeks and sildenafil 100 mg taken concurrently once weekly. Safety will be evaluated by the number of subjects experiencing adverse events and changes in safety parameters that include physical examination, clinical lab tests, and concomitant medication usage. The IIEF (International Index of Erectile Function), a multi-dimensional, validated diagnostic tool will be used to assess erectile function and treatment outcomes.

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®. For more information on Vesele® please visit

Viagra® is a trademark owned by Pfizer.

About Innovus Pharmaceuticals, Inc.

Headquartered in San Diego, Innovus Pharma is an emerging commercial stage pharmaceutical company delivering over-the-counter medicines and consumer care products for men's and women's health and respiratory diseases. The Company generates revenues from its lead products (a) BTH® Testosterone Booster, (b) BTH® Human Growth Agent, (c) Zestra® for female arousal and (d) EjectDelay® for premature ejaculation and has an additional five marketed products in this space, including (e) Sensum+® to help with reduced penile sensitivity, (f) Zestra Glide®, (g)Vesele® for promoting sexual health, (h) RecalMax™ for promoting brain and cognitive health, (i) Androferti® (in the US and Canada) to support overall male reproductive health and sperm quality, (j) BTH Vision Formula, (k) BTH Blood Sugar, among others and eventually FlutiCare™ OTC for allergic rhinitis, if its ANDA is approved by the U.S. FDA.

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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, results from the above pre-clinical and clinical trial, projected revenues, projected online subscribers, estimated market for its products, and statements about achieving its other development, growth, 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.


Chesapeake Group
Kevin Holmes, 410-825-3930


Chesapeake Group
Kevin Holmes, 410-825-3930