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

Innovus Pharmaceuticals (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 www.myvesele.com.
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.
For more information, go to www.innovuspharma.com,
www.zestra.com;
www.ejectdelay.com;
www.myvesele.com;
www.sensumplus.com;
www.myandroferti.com;
www.beyondhumantestosterone.com;
www.getbeyondhuman.com;
www.trybeyondhuman.com;
www.recalmax.com;
www.urivarx.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, 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.