INNV Innovus Pharma Files Its Product License Appl
Post# of 94265
Posted On: 10/29/2013 6:44:00 AM
INNV Innovus Pharma Files Its Product License Application for Commercialization of EjectDelay(TM) for Premature Ejaculation in Can...
Innovus Pharmaceuticals, Inc., ("Innovus Pharma" or the "Company") www.innovuspharma.com (OTCBB:INNV), today announced that the Company filed its Product License Application with Health Canada to market its premature ejaculation topical treatment EjectDelayTM. EjectDelayTM has the active drug Benzocaine and works by blocking the sodium channels of the nerves and therefore temporarily desensitizing the glans of the penis allowing longer ejaculatory time. If accepted by Health Canada, EjectDelayTM will be available as a 7.5% strength in 2oz over-the-counter gel and will not require a prescription. The product is not expected to be reimbursed by the Canadian government, therefore, the Company will be able to set the retail price through its potential commercial partners.
The approval process is approximately four months in Canada, assuming that no additional information is requested by Health Canada.
"If approved by Health Canada for commercialization, Canada would be the second country where the drug is approved and is yet another milestone for the Company," said Dr. Bassam Damaj, President and Chief Executive Officer of Innovus Pharma. "Our goal to make the product available on a worldwide basis," continued Dr. Damaj.
In addition, the Company is in the process of getting regulatory guidance from the relevant health authorities in Europe, the Middle East, and Latin America in order to file for market authorization for the product in these territories.
About EjectDelayTM and Premature Ejaculation
EjectDelayTM is an over-the-counter ("OTC") U.S. Food and Drug Administration compliant proprietary topical treatment containing the drug benzocaine and indicated for delay of premature ejaculation. The drug typically works within minutes of application to the glans of the penis. In clinical trials, the application of benzocaine has been shown to delay premature ejaculation by several minutes. For more information visit www.ejectdelay.com.
Premature ejaculation ("PE") is the most common sexual dysfunction reported by men but is still under-diagnosed and under-treated. PE can happen at any age and its prevalence is consistent across all ages. In an article in The Journal of Sexual Medicine in 2007 Sex Med 2007, D.L. Patrick, D. Rowland and M. Rothman state, "Global studies consistently report that 20-30% of men experience PE worldwide. This means that PE is experienced at similar rates across the globe."
About Innovus Pharmaceuticals, Inc.
Innovus Pharma, headquartered in La Jolla, California, is an emerging pharmaceuticals company that delivers innovative and uniquely presented and packaged health solutions through its over-the-counter medicines and consumer and health products.
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, to successfully commercialize such products as EjectDelayTM and to achieve its other development, commercialization and financial 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.
CONTACT: Innovus Pharma Contact:
Kevin Holmes
Chesapeake Group
info@chesapeakegp.com
T: 410-825-3930
Innovus Pharmaceuticals, Inc., ("Innovus Pharma" or the "Company") www.innovuspharma.com (OTCBB:INNV), today announced that the Company filed its Product License Application with Health Canada to market its premature ejaculation topical treatment EjectDelayTM. EjectDelayTM has the active drug Benzocaine and works by blocking the sodium channels of the nerves and therefore temporarily desensitizing the glans of the penis allowing longer ejaculatory time. If accepted by Health Canada, EjectDelayTM will be available as a 7.5% strength in 2oz over-the-counter gel and will not require a prescription. The product is not expected to be reimbursed by the Canadian government, therefore, the Company will be able to set the retail price through its potential commercial partners.
The approval process is approximately four months in Canada, assuming that no additional information is requested by Health Canada.
"If approved by Health Canada for commercialization, Canada would be the second country where the drug is approved and is yet another milestone for the Company," said Dr. Bassam Damaj, President and Chief Executive Officer of Innovus Pharma. "Our goal to make the product available on a worldwide basis," continued Dr. Damaj.
In addition, the Company is in the process of getting regulatory guidance from the relevant health authorities in Europe, the Middle East, and Latin America in order to file for market authorization for the product in these territories.
About EjectDelayTM and Premature Ejaculation
EjectDelayTM is an over-the-counter ("OTC") U.S. Food and Drug Administration compliant proprietary topical treatment containing the drug benzocaine and indicated for delay of premature ejaculation. The drug typically works within minutes of application to the glans of the penis. In clinical trials, the application of benzocaine has been shown to delay premature ejaculation by several minutes. For more information visit www.ejectdelay.com.
Premature ejaculation ("PE") is the most common sexual dysfunction reported by men but is still under-diagnosed and under-treated. PE can happen at any age and its prevalence is consistent across all ages. In an article in The Journal of Sexual Medicine in 2007 Sex Med 2007, D.L. Patrick, D. Rowland and M. Rothman state, "Global studies consistently report that 20-30% of men experience PE worldwide. This means that PE is experienced at similar rates across the globe."
About Innovus Pharmaceuticals, Inc.
Innovus Pharma, headquartered in La Jolla, California, is an emerging pharmaceuticals company that delivers innovative and uniquely presented and packaged health solutions through its over-the-counter medicines and consumer and health products.
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, to successfully commercialize such products as EjectDelayTM and to achieve its other development, commercialization and financial 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.
CONTACT: Innovus Pharma Contact:
Kevin Holmes
Chesapeake Group
info@chesapeakegp.com
T: 410-825-3930
(0)
(0)