Innovus Pharma Files For The Female Sexual Interest/Arousal Disorder (FSI/AD) Expanded Label Indication For Its Zestra® Product In Canada
5/13/2014 11:46:37 AM
SAN DIEGO, May 13, 2014 (GLOBE NEWSWIRE) -- Innovus Pharmaceuticals, Inc., ("Innovus Pharma" or the "Company") www.innovuspharma.com (OTCBB:INNV) today announced that it filed on the 8th of May 2014 for the "Female Sexual Interest/Arousal Disorder (FSI/AD)" expanded label indication for its marketed Zestra® product with Health Canada. Zestra® is currently approved and marketed in Canada for the indication of "Temporary Increase of Desire in Female Sexual Desire Disorder Women (FSDD)". The review process for the new label indication is 120 days from filing.
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. 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.
Zestra® 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® is commercialized in the U.S. and Canada and has sold millions of units since its launch in 2007.
"The expanded label if approved will make Zestra® the only product approved and marketed in Canada for FSI/AD and will make the product the first-to-market for this large therapeutic indication", said Dr. Damaj, President & Chief Executive Officer of the Company.
Our efforts to commercialize the products in additional markets such as Europe are moving forward as the Company is preparing for scientific guidance from the European Medicine Agency for the regulatory status path of the product in Europe 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® for female arousal, and EjectDelay™ for premature ejaculation, and has a total of four marketed products in this space including CIRCUMSerum™ (for sales outside the U.S. only) and Zestra® 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®, 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.
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