Innovus Pharma Announces the Publication of a Successful Clinical Trial in Overactive Bladder and Urine Incontinence Patients for its UriVarx® Product

Innovus Pharmaceuticals, Inc. ("Innovus Pharma" or the "Company”) (OTCQB Venture Market: INNV), an emerging commercial-stage pharmaceutical company that delivers safe, innovative and effective over-the-counter medicine and consumer care products to improve men’s and women's health and respiratory diseases, today announced that the human clinical trial for the patented formulation in its product UriVarx® product for bladder health was published in the peer reviewed journal, BMC Complementary and Alternative Medicine (Schoendorfer et al. BMC Complementary and Alternative Medicine (2018) 18:42). The study was conducted by the team of Dr. Niikee Schoendorfer in Australia in collaboration with the Company’s UriVarx® licensing partner Seipel Group, Ltd. The outcome of this study demonstrated both statistical significance and clinical relevance in reducing symptoms of Overactive Bladder ("OAB”), urinary frequency and/or urgency and incontinence.

In this study, one hundred and fifty participants (59% female, aged; mean ± SD; 63.5 ± 13.1 years) took part. At week 8, urinary day frequency was significantly lower (OR 0.01; 95%CI 0.01 to 0.02; p < 0.001) in response to treatment (mean ± SD; 7.69 ± 2.15/day) compared to placebo (10.95 ± 2.47/day). Similarly, episodes of nocturia were significantly fewer (OR 0.03; 95%CI 0.02 to 0.05) after 8 weeks of treatment (2.16 ± 1.49/night) versus placebo (3.14 ± 1.36/night). Symptoms of urgency (OR 0.02; 95%CI 0.01 to 0.03), and total incontinence (OR 0.03; 95% CI 0.01 to 0.06) were also lower (all p < 0.01) in the treatment group. Significant improvements in quality of life were reported after treatment in comparison to placebo. No significant side effects were observed resulting in withdrawal from treatment.

"We are very happy with the publication of the strong clinical data on the patented formulation in our best-selling product, UriVarx® for bladder health” stated Dr. Bassam Damaj, President and Chief Executive Officer of Innovus Pharma. "The publication of the clinical trial gives a tremendous boost to the clinical credibility of this product and we hope will translate into increased sales of this product from consumers who want a product for this disease indication that is scientifically sound and clinically-tested,” he continued.

About Innovus Pharmaceuticals, Inc.

Headquartered in San Diego, Innovus Pharma is an emerging OTC consumer goods and specialty pharmaceutical company engaged in the commercialization, licensing and development of safe and effective non-prescription medicine and consumer care products to improve men’s and women’s health and vitality and respiratory diseases. Innovus Pharma delivers innovative and uniquely presented and packaged health solutions through its (a) OTC medicines and consumer and health products, which we market directly, (b) commercial partners to primary care physicians, urologists, gynecologists and therapists, and (c) directly to consumers through our on-line channels, retailers and wholesalers. The Company is dedicated to be a leader in developing and marketing new OTC and branded Abbreviated New Drug Application ("ANDA”) products, men’s and women’s health supplements, related diagnostics and medical devices. The Company is actively pursuing opportunities where existing prescription drugs have recently, or are expected to, change from prescription (or Rx) to OTC, as well as related products.

For more information, go to www.innovuspharma.com; www.zestra.com; www.ejectdelay.com; www.vesele.com; www.urivarx.com; www.sensumplus.com; www.myandroferti.com; www.beyondhumantestosterone.com; www.getbeyondhuman.com; www.trybeyondhuman.com; www.recalmax.com; www.prostagorx.com; www.fluticare.com; www.allervarx.com; and www.apeaz.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, projected revenues from the UriVarx® product, estimated market for its products, and statements about achieving its other development, growth, 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 filing on Form S-1, 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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