SAN DIEGO, Oct. 10, 2011 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. ("Apricus Bio" or the "Company") (Nasdaq:APRI) (http://www.apricusbio.com) announced today that the submission of an abstract entitled, "Integrated Efficacy Results of Two Phase 3 Clinical Trials for Male Erectile Dysfunction using Vitaros®, a Topical Alprostadil Cream with Subgroup Analyses," was accepted as a moderated poster (#114) at the upcoming Sexual Medicine Society of Northern America ("SMSNA") conference taking place in Las Vegas, November 10 - 13, 2011. This is the second Apricus Bio abstract accepted by the SMSNA for presentation at this key industry conference. On October 6, 2011, Apricus Bio announced that its abstract related to the Company's Femprox® clinical data for Female Sexual Arousal Disorder, had been accepted as a moderated poster.
Dr. Stephen Auerbach, a member of the Company's Vitaros® Clinical Advisory Board and Medical Director, California Professional Research, Newport Beach, California, will present the poster with a short oral presentation and question and answer session on Saturday November 12, 2011 during the Medical Pharmacology session, scheduled to take place from 2:30 pm to 4:00 pm PST.
The poster presentation will discuss additional subgroup analyses on a combined dataset from two pivotal Phase 3 clinical trials in 1,732 patients suffering from erectile dysfunction ("ED"). The data further demonstrates the efficacy and safety of Vitaros® as an easy-to-administer, topical first-line treatment option for all ED patients, independent of age, body mass index ("BMI") and risk factors, such as cardiovascular disease and diabetes.
Apricus Bio received marketing approval for Vitaros® as a first-line treatment for ED from Health Canada in November 2010 for sales of the product in that country. In April 2011, the Company filed a marketing application in the European Union, under the Decentralized Procedure ("DCP"), for Vitaros® for the treatment of ED, with the Netherlands as its Reference Member State. Under the DCP, approval in a Reference Member State means that a drug may be sold in all of the European Union countries that were filed with the DCP as Concerned Member States. In July 2011, Apricus Bio filed for regulatory approval with Swissmedic, the Swiss Agency for Therapeutic Products for marketing of Vitaros® in that country. Preparations for filing in certain Latin American countries are ongoing.
About Vitaros® and the ED Market
The current leading drugs for erectile dysfunction are Viagra®, Cialis® and Levitra®, which are taken in pill form and work by inhibiting an enzyme called PDE5.
There is still a need for new, safe and effective treatments, however, especially for those patients who cannot or do not respond well to oral medication. Vitaros® differs from Viagra®, Cialis® and Levitra® in two ways. Instead of a pill, Vitaros® is applied directly to the penis as a cream. The topical application helps to reduce side effects and offers men who do not do well with the existing drugs a patient-friendly alternative.
Second, Vitaros® operates by a different biochemical mechanism than oral ED medications. It contains a previously marketed ED drug known by the chemical name of alprostadil. When absorbed through the skin, alprostadil directly boosts blood flow, thereby causing an erection within minutes, which the Company believes is much faster than the results from the currently marketed oral treatments.
Alprostadil is currently marketed as an injectable drug or as a suppository inserted into the urethra. The key innovation behind Vitaros® is combining alprostadil with Apricus Bio's NexACT® delivery technology, which allows the drug to pass through the skin and makes the treatment much easier to apply.
Viagra® is a registered trademark of Pfizer, Inc.; Cialis® is a registered trademark of Lilly, USA; Levitra®, is a registered trademark of Bayer A.G.; and Vitaros® is a registered trademark in Canada held by Apricus Bio, and in the U.S. held by Warner Chilcott Company.
About Apricus Biosciences, Inc.
Apricus Bio, a San Diego-based, revenue-generating, biopharmaceutical company, has leveraged the flexibility of its clinically-validated NexACT® drug delivery technology to enable multi-route administration of new and improved compounds across numerous therapeutic classes.
Revenues and growth are driven from out-licensing of this technology for the development and commercialization of such compounds to pharmaceutical and biotechnology companies worldwide. In addition, the Company is seeking to monetize its existing Rx Division product pipeline, including its first product, Vitaros®, approved in Canada for the treatment of erectile dysfunction, which is currently expected to be available on the Canadian market in 2011, as well as compounds in development from pre-clinical through Phase III, currently focused on Sexual Dysfunction, Oncology, Dermatology, Autoimmune, Pain, Anti-Infectives, Diabetes and Cosmeceuticals among others.
The Company is also developing its Consumer Healthcare Division by developing a number of drugs that utilize the Company's NexACT® technology to comply with the FDA's over-the-counter ("OTC") requirements, be cleared as 510(k) topical creams that are considered to be medical devices or approved as Abbreviated New Drug Applications ("ANDAs") as generic drugs. The Company will also seek to market such drugs through these similar procedures in foreign countries.
For further information on Apricus Bio, visit http://www.apricusbio.com and for information on its subsidiary please visit www.nexmedusa.com. Information may also be found at http://twitter.com/apricusbio, and http://facebook.com/apricusbio.
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 receive issued patents on its NexACT® technology and products such as Vitaros®, develop such patented technology into product candidates, have its Rx Division products and product candidates approved by relevant regulatory authorities and its Consumer Healthcare Division products either approved or cleared by relevant regulatory authorities or be in compliance with appropriate regulatory requirements, to successfully manufacture and commercialize such Rx Division products along with its Consumer Healthcare Division products and product candidates and to achieve its other development, commercialization and financial goals. 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.