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Innovus Pharmaceuticals Receives Approval for the Expanded Label Indication for its Zestra(R) Product in Canada for the Temporary Increase of Desire/Arousal in Women with Female Sexual Interest/Arousal Disorder

2014-10-24 06:00 ET - News Release


SAN DIEGO, CA / ACCESSWIRE / October 24, 2014 / Innovus Pharmaceuticals,
Inc., ("Innovus Pharma" or the "Company") www.innovuspharma.com (OTC: BB: INNV)
today announced that it has received approval from Health Canada for an
expanded label for its marketed Zestra(R) product. Zestra(R) is currently approved and marketed in
Canada for the indication of "Temporary Increase of Desire in Female Sexual
Desire Disorder Women ("FSDD")". The new indication approved is expanded to
that of "Temporary Increase of Desire/Arousal in Women with Female Sexual
Interest/Arousal Disorder" ("FSI/AD").

FSI/AD, is
a persistent or recurring inability to attain or maintain adequate sexual
excitement until the completion of a sexual activity. The diagnosis can
also refer to an inadequate lubrication-swelling response normally present
during arousal and sexual activity
causing personal distress. FSI/AD is a larger market that that of FSDD and published
papers on the FSI/AD market size such as Harris, Interactive Women's
Sexual Health Survey (2009) estimate it to be equal or larger than the
market for erectile dysfunction in males, and possibly larger with an estimated
over 20 million women suffering in the US and over 2 million women suffering in
Canada.

There are
no current prescription products approved in Canada or anywhere in the world
for this indication which makes Zestra(R) a very valuable product to treat such an
indication where it is approved.



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. by the Company and in Canada by the
Company's licensing partner, Orimed Pharma Inc., a subsidiary of Jamp Pharma, 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 Quantitative
Consumer Study, October 2009, 43% of women have sexual difficulties as compared
to ~31% of men who have erectile dysfunction (a market size close to $6B
worldwide).

"The
expanded label makes Zestra(R) the only product approved and marketed in Canada
for FSI/AD and makes the product the first-to-market for this large therapeutic
indication in this country", said Dr. Damaj, President & Chief Executive
Officer of the Company. "Our efforts to commercialize this product in
additional markets such as Europe are moving forward as the Company is
preparing for scientific guidance from the European Medicine Agency for filing
Zestra(R) as a Herbal-based
Medicine in Europe for the same indication," continued Dr. Damaj.

About
Innovus Pharmaceuticals, Inc.

Headquartered in San Diego,
Innovus Pharma is an emerging leader in the OTC male and female sexual
dysfunction products. The Company generates revenues from its lead products
Zestra(R) for female arousal, and EjectDelay(TM) for premature ejaculation, and has
a total of four marketed products in this space including Sensum+ (formerlyCIRCUMSerum(TM) (for sales outside the U.S. only) and Zestra(R) Glide.

For more
information, go to www.innovuspharma.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 relating to such products
such as Zestra(R) in Canada, to successfully commercialize such 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.
###
Innovus Pharma Contact:

Kevin Holmes
Chesapeake Group
info@chesapeakegp.com
T: 410-825-3930




SOURCE: Innovus Pharmaceuticals, Inc.

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