Apricus Biosciences Announces Poster Presentation of Femprox(R) Phase III Clinical Data at American Urological Association Annual Meeting


SAN DIEGO, May 4, 2012 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. ("Apricus Bio" or the "Company") (Nasdaq:APRI) (http://www.apricusbio.com) announced today a poster titled, "Updated analyses of randomized, double-blind, Phase 3 study of Femprox®, an alprostadil cream with a novel transdermal delivery technology for the treatment of female sexual arousal disorder (FSAD)," will be presented as a moderated poster (#1498) at the American Urological Association Annual Meeting which is being held May 19-23, 2012 in Atlanta, GA.

The poster presentation will discuss an updated analysis of the 400-women Phase III clinical trial conducted by the Company to provide further evidence of the statistically significant efficacy and safety profile of Apricus Bio's investigational drug, Femprox® (topical alprostadil 0.4 % cream), for the treatment of FSAD in pre- and post-menopausal women.

The data will be presented by Dr. Irwin Goldstein, Director of Sexual Medicine at the Alvarado Hospital in San Diego, and a member of Apricus Bio's Femprox® Clinical Advisory Board. Dr. Goldstein will present the data during the session titled: "Sexual Function/Dysfunction/Andrology: Medical and Non-Surgical Therapy," taking place Tuesday, May 22 from 8-10 a.m. local time. Dr. Goldstein will give a short oral presentation which will be followed by a question and answer period. Dr. Goldstein is the Editor of The Journal of Sexual Medicine, a member of numerous sexual medicine societies, the author or co-author of approximately 260 peer-reviewed papers, and an expert in the area of women's sexual health.

About Femprox®

Femprox® is an alprostadil-based cream intended for the treatment of FSAD. Apricus Bio has completed nine clinical studies to date, including one, 98-patient Phase II study in the U.S. and a 400-patient Phase III study in China.

It is the Company's understanding that no product is currently approved for FSAD in the U.S., a persistent or recurring inability to attain, or maintain adequate sexual excitement, causing personal distress.

Femprox® exerts a local, relaxant effect on vulvar and clitoral blood vessels in women, leading to increased blood flow. The resultant increase in lubrication and sensory feedback is believed to produce a clinically significant increase in sexual arousal in women with FSAD.

About Apricus Biosciences, Inc.

Apricus Bio is a San Diego-based revenue-generating pharmaceutical company, with commercial products and a broad pipeline across numerous therapeutic classes.

Revenues and growth are driven from the sales of the Company's commercial products through its Apricus Pharmaceuticals USA, Inc. and NexMed (USA), Inc. subsidiaries and through out-licensing in certain territories of its product pipeline and NexACT® technology.

Apricus Bio's current NexACT® pipeline includes Vitaros®, approved in Canada for the treatment of erectile dysfunction, as well as compounds in development from pre-clinical through pre-registration currently focused on Sexual Dysfunction, Oncology, Dermatology, Autoimmune, Pain, Anti-Infectives, Diabetes and Consumer Healthcare.

Apricus Bio currently markets Totect® (dexrazoxane HCl), the only drug approved in the US for the treatment of anthracycline extravasation. The Company also plans to market in the U.S. or certain other countries the following products: (a) Granisol® (granisetron HCI) oral solution, the only FDA-approved, oral, ready-to-use liquid solution of granisetron, (b) Aquoral™, an FDA-cleared, prescription-only spray for the treatment of Xerostomia (the medical term for dry mouth due to a lack of saliva) and (c) NitroMist® (nitroglycerin sublingual spray), an FDA-approved nitrate vasodilator indicated for acute relief of an attack or acute prophylaxis of angina pectoris (chest pain) due to coronary artery disease (narrowing of the blood vessels that supply blood to the heart).

The Company also expects to develop and/or acquire and then bring to market additional pharmaceutical products in areas of care that will benefit patient needs worldwide.

For further information on Apricus Bio, visit http://www.apricusbio.com, and for information on its subsidiary please visit http://www.nexmedusa.com. You can also receive information at http://twitter.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 further develop its products and product candidates, to have its products and product candidates such as Femprox® receive patent protection and be approved by relevant regulatory authorities, to successfully commercialize such products as Totect® , Granisol® , Aquoral™ and NitroMist™ and Vitaros® for erectile dysfunction and NexACT® product candidates and drug delivery technology and to achieve its 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.



            

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