Innovus Pharma Files Product License Application For The Commercialization Of Its Seasonal Allergic Rhinitis Product In Canada
Published: Aug 24, 2017
The Company looks to add AllerVarx™ to its growing portfolio of approved drugs and products in Canada
SAN DIEGO--(BUSINESS WIRE)--Innovus Pharmaceuticals, Inc. ("Innovus Pharma" or the “Company”) (OTCQB Venture Market: INNV), an emerging commercial-stage pharmaceutical company, today announced the filing of a Natural Health Product License Application (“NHP”) in Canada for its product AllerVarx™, which is a clinically-proven, patented supplement, formulated to help reduce nasal and/or eye symptoms in subjects with seasonal allergic rhinitis. If accepted by Health Canada, AllerVarx™ will be available as an NHP and can be prescribed by physicians to help reduce nasal and/or eye symptoms for seasonal allergic rhinitis. The review process is approximately seven months in Canada assuming no additional information is requested by Health Canada.
“We are very excited about filing the NHP for our AllerVarx™ product in Canada”
“We are very excited about filing the NHP for our AllerVarx™ product in Canada,” said Dr. Bassam Damaj, the President and Chief Executive Officer of Innovus Pharma. “We look forward to adding this important product to our growing portfolio of approved drugs and products in Canada once it is approved by Health Canada for marketing and sales in that country.”
In addition to AllerVarx™, Innovus Pharma has previously announced the filing of a PLA for its drug Xyralid™ with Health Canada, the filing of the NHP to market its leading product Vesele® with that agency and is awaiting approval decision for its NHP application to market UriVarx™. If all of the above PLAs are approved, then the Company will have seven products for sale on the Canadian market including Zestra®, Zestra Glide® and Uxor™ (EjectDelay™), which are currently marketed by the Company’s distribution partner there, Orimed Pharma.
AllerVarx™ was studied in a published clinical trial assessing the reduction of both nasal and ocular symptoms in allergic patients, and daily consumption of anti-allergic drugs, over a period of 30 days. AllerVarx™ showed a reduction of approximately 70% in total symptom scores and a reduction of approximately 73% in the use of anti-allergic drugs. There were no side effects noted during the administration of AllerVarx™ and all the patients enrolled finished the study with good compliance.
The World Health Organization (“WHO”) classifies allergies as the fourth most important chronic disease in the world. Allergic Rhinitis (“AR”) is the most common form of non-infectious rhinitis, affecting between 10% and 30% of all adults in the United States, and as many as 40% of U.S. children. Epidemiological studies show that the prevalence of AR is expected to still be important in the next decades. The World Allergy Organization (“WAO”) has estimated that 400 million people in the world suffer from AR, which remains to a large extent underdiagnosed and undertreated.
AllerVarx™ is a patented formulation produced in bilayer tablets with a technology that allows a controlled release of the ingredients. The fast-release layer allows the rapid antihistaminic activity of Perilla. The sustained-release layer enhances Quercetin and Vitamin D3 bioavailability, thanks to its lipidic matrix, and exerts anti-allergic activity spread over time. For more information on the product please visit www.allervarx.com.
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 being a leader in developing and marketing new OTC and branded Abbreviated New Drug Application (“ANDA”) products. The Company is actively pursuing opportunities where existing prescription drugs have recently, or are expected to, change from prescription (or Rx) to OTC.
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.
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 AllerVarx™ product in Canada 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.