INNV Innovus Pharma Selects Lebanese-Canadian Hospital for Its Post-Marketing Clinical Trials for CIRCUMserum(TM) and EjectDelay(T...
Innovus Pharmaceuticals, Inc., ("Innovus Pharma" or the "Company") www.innovuspharma.com (OTCBB:INNV) today announced that the Company selected the Lebanese-Canadian Hospital in Beirut, Lebanon for its two post-marketing trials for CIRCUMserum™ to alleviate reduced penile sensitivity and EjectDelay™ for premature ejaculation.
CIRCUMserum™ includes the active medicinal ingredient cinnamon oil (cinnamaldehyde) 0.75% and works by activating the transient receptor potential channel A1 (TRPA1) channels leading to exciting the nociceptive responsive nerve endings to increase penile sensitivity without affecting the thickness of the skin. EjectDelay's™ active ingredient is a proprietary fast absorbing and vanishing gel formulation with the active drug benzocaine at 7.5% designed to reduce transfer to the partner.
The two studies will be placebo-controlled, parallel, double-blind studies for 12 weeks of treatment. Both studies will enroll a total of 36 patients each. The EjectDelay™ study will evaluate the Intra-Vaginal Ejaculatory Time (I-ELT) achieved by the product in patients with premature ejaculation and the effect on the partner and will be the only study done in this population on benzocaine based topical products for this indication. The CIRCUMserum™ study will evaluate the effect of the product on increasing penile sensitivity and reduction of the time to ejaculation in men who needs between 15-20 min to ejaculate during sexual intercourse.
The Middle East and North Africa ("MENA") market is a large market for these two indications (premature ejaculation and reduced penile sensitivity) and the two studies, once successfully completed, will be the first controlled data to be reported in such a patient population.
"We are committed to provide the two products with strong clinical data to support the marketing of the two products in all markets," said Dr. Bassam Damaj, President and Chief Executive Officer of Innovus Pharma. "We are seeing a great interest from large pharmaceutical companies for the two products and the clinical data will help us and our partners in our commercial launches in the different markets around the world," continued Dr. Damaj.
About EjectDelay™ and Premature Ejaculation
EjectDelay™ 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 CIRCUMserum™ and Reduced Penile Sensitivity
Innovus Pharma acquired ex-US rights to CIRCUMserum™ from Centric Research Institute ("CRI") in early 2013. Reduced Penile Sensitivity ("RPS") refers to the condition of decreased sensation in the penis during sexual activity. Subjects with RPS report difficulty in stimulating the penis, maintaining erection, and/or achieving orgasm. The duration of intercourse is typically prolonged due to delayed orgasm.
Normal ejaculation is quantified and diagnosed by the time it takes a man to ejaculate from penetrating the vagina. Normal men will ejaculate between 4-8 minutes following penetration of the vagina. Loss of sensation in the penis will cause men to ejaculate after longer than 15 minutes and may take up to 30 minutes, with some never being able to ejaculate.
CIRCUMserum™ is an all-natural cream with the active medicinal excipient cinnamon oil (cinnamaldehyde) at 0.75%. CIRCUMserum™ activates the TRPA1 channels, leading to exciting the nociceptive responsive nerve endings to increase penile sensitivity without affecting the thickness of the skin. For more information visit www.circumserum.com.
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 CIRCUMserumTM and to achieve its other development, commercialization and financial objectives. Even if this clinical study with the Lebanese-Canadian Hospital is successful, there is no guarantee that the Company will be able to make money on its sales of both products. 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 selected the Lebanese-Canadian Hospital in Beirut, Lebanon for its two post-marketing trials for CIRCUMserum™ to alleviate reduced penile sensitivity and EjectDelay™ for premature ejaculation.
CIRCUMserum™ includes the active medicinal ingredient cinnamon oil (cinnamaldehyde) 0.75% and works by activating the transient receptor potential channel A1 (TRPA1) channels leading to exciting the nociceptive responsive nerve endings to increase penile sensitivity without affecting the thickness of the skin. EjectDelay's™ active ingredient is a proprietary fast absorbing and vanishing gel formulation with the active drug benzocaine at 7.5% designed to reduce transfer to the partner.
The two studies will be placebo-controlled, parallel, double-blind studies for 12 weeks of treatment. Both studies will enroll a total of 36 patients each. The EjectDelay™ study will evaluate the Intra-Vaginal Ejaculatory Time (I-ELT) achieved by the product in patients with premature ejaculation and the effect on the partner and will be the only study done in this population on benzocaine based topical products for this indication. The CIRCUMserum™ study will evaluate the effect of the product on increasing penile sensitivity and reduction of the time to ejaculation in men who needs between 15-20 min to ejaculate during sexual intercourse.
The Middle East and North Africa ("MENA") market is a large market for these two indications (premature ejaculation and reduced penile sensitivity) and the two studies, once successfully completed, will be the first controlled data to be reported in such a patient population.
"We are committed to provide the two products with strong clinical data to support the marketing of the two products in all markets," said Dr. Bassam Damaj, President and Chief Executive Officer of Innovus Pharma. "We are seeing a great interest from large pharmaceutical companies for the two products and the clinical data will help us and our partners in our commercial launches in the different markets around the world," continued Dr. Damaj.
About EjectDelay™ and Premature Ejaculation
EjectDelay™ 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 CIRCUMserum™ and Reduced Penile Sensitivity
Innovus Pharma acquired ex-US rights to CIRCUMserum™ from Centric Research Institute ("CRI") in early 2013. Reduced Penile Sensitivity ("RPS") refers to the condition of decreased sensation in the penis during sexual activity. Subjects with RPS report difficulty in stimulating the penis, maintaining erection, and/or achieving orgasm. The duration of intercourse is typically prolonged due to delayed orgasm.
Normal ejaculation is quantified and diagnosed by the time it takes a man to ejaculate from penetrating the vagina. Normal men will ejaculate between 4-8 minutes following penetration of the vagina. Loss of sensation in the penis will cause men to ejaculate after longer than 15 minutes and may take up to 30 minutes, with some never being able to ejaculate.
CIRCUMserum™ is an all-natural cream with the active medicinal excipient cinnamon oil (cinnamaldehyde) at 0.75%. CIRCUMserum™ activates the TRPA1 channels, leading to exciting the nociceptive responsive nerve endings to increase penile sensitivity without affecting the thickness of the skin. For more information visit www.circumserum.com.
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 CIRCUMserumTM and to achieve its other development, commercialization and financial objectives. Even if this clinical study with the Lebanese-Canadian Hospital is successful, there is no guarantee that the Company will be able to make money on its sales of both products. 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
