Innovus Pharma Files Its Product License Application In Canada For The Commercialization Of Its Drug Xyralid
Published: Jul 31, 2017
Xyralid™, a Lidocaine-based Cream for the Relief of Pain and Symptoms Caused by Hemorrhoids, will be Targeting over 1.2 Million Patients in Canada
SAN DIEGO--(BUSINESS WIRE)--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 the filing by it of a Product License Application (“PLA”) in Canada for its drug Xyralid™, which is a clinically-proven, lidocaine-based cream for the relief of pain and symptoms caused by hemorrhoids. If accepted by Health Canada, Xyralid™ will be available as an over-the-counter (“OTC”) or behind the counter, fast-acting, hemorrhoid cream and will not require a prescription. The review process is approximately four months in Canada assuming no additional information is requested by Health Canada.
“We are very excited about filing the PLA for our Xyralid™ drug in Canada,” said Dr. Bassam Damaj, the President and Chief Executive Officer of Innovus Pharma. “If approved by Health Canada, Xyralid™ will be our fourth product on the Canadian market including Zestra®, Zestra Glide® and Uxor™ (EjectDelay™) marketed by Orimed Pharma.”
In addition to Xyralid™, Innovus Pharma announced on May 18, 2017 the filing of the PLA to market its leading product Vesele® for sexual dysfunction with Health Canada.
Hemorrhoids, also called “piles”, are swollen and inflamed veins in the anus and lower rectum. Hemorrhoids may result from straining during bowel movements or from the increased pressure on these veins during pregnancy, among other causes. Hemorrhoids may be located inside the rectum (internal hemorrhoids) or they may develop under the skin around the anus (external hemorrhoids). There are over 1.2 million hemorrhoid sufferers in Canada making it a very large market1.
Xyralid™ is an FDA-OTC monograph compliant, fast-acting and powerful hemorrhoid anesthetic cream. It contains the active ingredient drug, lidocaine, which provides fast relief for the pain and symptoms caused by hemorrhoids.
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 Xyralid™ drug 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.
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