SAN DIEGO, May 7, 2013 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. ("Apricus Bio" or the "Company") (Nasdaq:APRI) (www.apricusbio.com) announced today that John P. Mulhall, MD, Director of the Male Sexual and Reproductive Medicine Program at Memorial Sloan-Kettering Cancer Center, will present results from an analysis of existing Phase 3 data for Vitaros®, the Company's lead product candidate for the treatment of erectile dysfunction (ED), at the American Urological Association Annual Meeting which is taking place May 4-8, 2013 in San Diego, CA.
The abstract titled, "Vitaros® Efficacy and Safety in Viagra® Non-Responders with Longer Term Use," will be presented as a moderated poster (#1519) during a session titled "Sexual Function/Dysfunction/Andrology: Medical and Non-Surgical Therapy," taking place Tuesday, May 7, 2013 from 8-10 a.m. local time. Dr. Mulhall will give a short oral presentation, which will then be followed by a question and answer period.
This analysis evaluated the safety and efficacy of Vitaros® after 12 weeks, and longer term use, in men previously unresponsive to phosphodiesterase type 5 (PDE-5) inhibitors, such as Viagra® (n=325). Results showed that 200mcg and 300mcg doses of Vitaros® improved erections in this population and adverse events (AE) were mild to moderate, similar to those seen in the control group, and decreased with repeated exposure.
"PDE-5 inhibitors, while effective, address only a portion of the ED patient population. In the current treatment landscape, this leaves a large population of unresponsive or contraindicated patients with few or no alternatives," said Dr. John Mulhall, lead author and Director of the Male Sexual and Reproductive Medicine Program at Memorial Sloan-Kettering Cancer Center. "Vitaros® utilizes a novel mechanism of action that has demonstrated successful ED therapy without the side effects associated with current products, making it an effective and practical option for these patients."
Dr. Mulhall is also an Associate Editor for the Journal of Sexual Medicine and past President of the Sexual Medicine Society of North America.
Vitaros®, Apricus Bio's lead product candidate for the treatment of ED, is a topically-applied cream formulation of alprostadil, a vasodilator, which directly increases blood flow to the penis, causing an erection. Vitaros is approved in Canada and Apricus Bio has filed for regulatory approval in Europe. Alprostadil is a widely accepted alternative to the PDE5 inhibitors for difficult to treat patients, and Vitaros® is relatively safe and effective, and offers greater market opportunity due to its patient-friendly form versus both other alprostadil dosage forms and also relative to oral ED products. With a market affecting nearly 150 million men worldwide and representing approximately $2.6 billion in revenue – excluding the U.S. – Vitaros® represents a major market opportunity, particularly as a distinct product that addresses a significant underserved population.
About Apricus Biosciences, Inc.
Apricus Biosciences, Inc. (Nasdaq:APRI) is a pharmaceutical company that develops and markets innovative treatments that help large patient populations across numerous, large-market therapeutic classes including male and female sexual health. The Company has one approved product, Vitaros®, for the treatment of erectile dysfunction, which will be marketed in Canada by Abbott Laboratories, and Femprox®, a product candidate, for the treatment of female sexual arousal disorder, which successfully completed one approximately 400-patient Phase III study in China.
Apricus Bio's Forward-Looking Statement 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: its ability to achieve its development, commercialization and financial goals, its ability to further develop its products and product candidates including Vitaros® for erectile dysfunction and to have this product be effective in men who have previously tried PDE-5 inhibitors, the timing for a commercial launch of Vitaros® in any country, and its ability to have its products and product candidates approved by relevant regulatory authorities, and its ability to receive appropriate regulatory guidance on Femprox® from various regulatory authorities, to successfully conduct further clinical trials with this product and its ability to eventually commercialize Femprox®. 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.
Source:Apricus Biosciences, Inc.