Innovus Pharmaceuticals Announces Successful Top Line Clinical Results From Sensum+(R) in Diabetic and Non-Diabetic Circumcised Men With Low Penile Sensitivity

Results Reported Show Close to 200% Increase in Penile Sensitivity

SAN DIEGO, CA--(Marketwired - Nov 19, 2015) - Innovus Pharmaceuticals, Inc. ("Innovus Pharma" or the "Company") (OTCQB: INNV), a company focusing on the commercialization of over-the-counter ("OTC") and consumer products for men's and women's health, vitality and respiratory diseases, today announced the Company's top line results from its Sensum+® human survey use clinical trial in circumcised men with low penile sensitivity.

Results from the study showed statistically significant increase in all endpoints measured including:

1. 197% in penile sensitivity 
2. 60% reduction in time for Masturbation Ejaculatory Latency Time (MELT) in diabetic men 
3. Over 300% increase in satisfaction 
4. Close to 275% increase in Partner's Satisfaction

Endpoint   Baseline   Sensum+®   P Value
Penile Sensitivity   2.571 ± 0.3431, N=14   5.071 ± 0.3847, N=14   < 0.0001
Masturbation Ejaculatory Latency Time (MELT, seconds); Mixed   1408 ± 117.3 N=6   946.8 ± 114.1 N=6   0.0182
Masturbation Ejaculatory Latency Time (MELT, seconds); Diabetic   1483 ± 167.7 N=4   986.3 ± 175.8 N=4   0.0869
Ejaculatory Time (M/IELT); Mixed   1079 ± 110.2 N=8   833.9 ± 102.8 N=8   0.1257
Sex Life Satisfaction   1.231 ± 0.1216 N=13   4.154 ± 0.2963 N=13   < 0.0001
Partner's Satisfaction   1.231 ± 0.1216 N=13   3.385 ± 0.3497 N=13   < 0.0001

About the INNV-RPS1001-M Use Survey Trial

The clinical use survey study was developed to assess the effect of Sensum+® on penile sensitivity after 3 weeks of twice daily treatment

  • Country: Mexico
  • Number of patients: 14 patients (Age: 23-69)
  • Duration: 5 weeks including 1 week of baseline survey and 1 week post treatment period (exit survey)
  • Application: To the head and shaft of the penis twice a day for 3 weeks
  • Each person received three dispensers of Sensum+® and was asked to apply 1-2 pump (~ 150 mg-300mg cream) to the head and shaft of the penis twice daily and abstain from all sexual activities during the first week of treatment.
  • Each survey included questions on previous history of reduced penile sensitivity (RPS), and the effect of Sensum+® on:
    • Penile sensitivity
    • Masturbation Ejaculatory Latency Time (MELT)
    • Intra-Vaginal Ejaculatory Latency Time (IELT)
    • Sex life satisfaction and partner's satisfaction

Pursuant to these clinical trials, the data indicate that Sensum+® was very well tolerated with no serious adverse events reported.

Sensum+® is a proprietary topical formulation specifically designed to increase penile sensitivity.

"We are thrilled about these results from the Sensum+® human use survey trial which we believe confirms that activity of the product and increase its commercial potential," said Dr. Bassam Damaj, President & CEO of the Innovus Pharma. "Reduced penile sensitivity is a major concern to men and it is estimated to affect millions around the world," continued Dr. Damaj.

About Sensum+® and Reduced Penile Sensitivity (RPS)

Sensum+® is a patented blend of essential oils and natural botanicals including rose oil, sweet almond oil, cinnamon bark oil, and other extracts. The main ingredient of Sensum+® (cinnamon oil) works by activating the Transient Receptor Potential A1 (TRPA-1) channels responsible for the heat and cold sensation of the skin and results in an increase of sensation that current users welcome and appreciate. The safety and efficacy of Sensum+® was evaluated in 2 post marketing survey studies in circumcised and non-circumcised men. A total of 382 men used Sensum+® twice daily for fourteen consecutive days followed by once daily for 8 weeks and as needed thereafter.

Reduced penile sensitivity is a major problem associated with many diseases such as hernia surgery, the use of anti-depressants, circumcision, multiple sclerosis and others. There are no approved products to treat RPS.

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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 Sensum+®, to successfully commercialize such products in Canada and in other countries and regions, 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.

Contact Information:

Reuven Rubinson
Vice President of Finance