CPhI MEA 2018

Industry Press Releases

Innovus Pharma Announces U.S. Food and Drug Administration Clearance of Its UriVarx® Urinary Tract Infection Test Strips

Friday, Jan 12, 2018

Innovus Pharmaceuticals, Inc., 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 U.S. Food and Drug Administration (“FDA”) has cleared its UriVarx® Urinary Tract Infection (“UTI”) test strips under the 510(k) filing of its manufacturing partner, ACON Laboratories, Inc. (“ACON”). Innovus Pharma will offer the recently cleared UriVarx® UTI test strips, which provide results in 2-minutes, to its customers who buy its UriVarx® product. The UTI test strips are complementary to the Company’s UriVarx® supplement currently on the market and clinically tested in patients with overactive bladder (“OAB”) and urinary incontinence (“UI”). The UTI test strips will also be offered separately by Innovus Pharma and are manufactured by ACON. Innovus Pharma currently is expected to launch the UTI strips in Q1 2018.

According to WebMD, UTIs are the most common bacterial infections in the United States. According to a study by the National Institutes of Health in 2007 (NIH publication 075512) by Griebling et al., the prevalence of UTI is found to be higher in women. Nearly 20% of UTIs are found in men. Patients with OAB and UI have a higher occurrence of UTI infections and early detection is key in better responses to treatments.

“We are very pleased that ACON has secured the FDA clearance of the UriVarx® UTI test strips,” stated Dr. Bassam Damaj, President and Chief Executive Officer of Innovus Pharma. “We look forward to launching the UriVarx® strips with our UriVarx® clinical supplement for bladder health to enable our customers to be able to use our FDA cleared UTI test strips to monitor ongoing bladder infections from the convenience of their homes. We expect the addition of the UTI strips to increase our clinical supplement sales and the average life cycle of our monthly product subscriptions,” he continued.

The Company recently announced the approval of UriVarx® by Health Canada and the signing of a commercial license agreement with Acerus Pharmaceuticals Corporation in Canada for the product.

About UriVarx® Clinical Supplement

UriVarx® is clinically published to reduce urinary urgency, accidents and both day and night frequency in OAB and UI patients.

UriVarx® has undergone two double blind and comparative trials in both male and female OAB and UI patients. The clinical results include:

Reduction of ~56% in Urge Incontinence;
Reduction of ~66% in Stress Incontinence;
Reduction of ~61% in Urinary Urgency;
Reduction of ~33% in Urinary Frequency meaning the total average urinary frequency was in the normal/ideal range after two months of use; and
Reduction of ~46% in Nocturia.

According to the U.S. National Association for Continence (“NAFC”), OAB is a medical term that describes various symptoms caused by involuntary bladder spasms, including urinary frequency, especially at night, and urgency with or without involuntary leakage. These symptoms may occur without obvious cause or be secondary to certain diseases of the nervous system. The NAFC estimates that nearly 25 million Americans suffer from some form of OAB or incontinence. The condition, with frequency and urgency only, affects men and women of all ages, although most are under age 65.

About the UriVarx® FDA Cleared UTI Test

The UriVarx® UTI test strips are FDA-cleared tests for the detection of leukocytes and nitrites to add in the screening of Urinary Tract Infection for self-testing. The test has undergone clinical trials and the results can be seen in two minutes.

According to a study by Grand View Research (April 2016), the market size for urinalysis tests in 2015 worldwide was $1.37 billion and in North America was $510 million of which UTI testing represented a large percentage of that market.

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.myvesele.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.

About ACON Laboratories, Inc.

ACON Laboratories Inc. is a privately-owned diagnostics and medical device company, which was founded in 1995, with its headquarters located in San Diego, California. ACON Laboratories, Inc. produces a broad range of medical diagnostic and healthcare products that are sold in over 130 countries worldwide. The company continues to expand its product lines through extensive research and development, with the goal of helping improve the health and well-being of patients around the world. ACON’s manufacturing facility is a US FDA registered manufacturer of rapid diagnostic and healthcare products.

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 and the accompanying UTI test strips in the United States if approved in that country, 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.

Contacts
Emerging Markets Consulting, LLC
James S. Painter III, 407 340 0226
jamespainter@emergingmarketsllc.com

 

Source: businesswire.com

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