SAN DIEGO, June 21, 2013 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. ("Apricus Bio" or the "Company") (Nasdaq:APRI) (www.apricusbio.com) announced today that it will present a poster with results of an analysis of existing Phase 3 data for Vitaros®, the Company's lead product candidate for the treatment of erectile dysfunction (ED), at the International Symposium on Prostate, Androgens and Men's Sexual Health. The Symposium is being convened jointly by the European Society of Sexual Medicine ("ESSM") and the International Society for Sexual Medicine ("ISSM"), and is taking place June 21-23, 2013 in Berlin, Germany.
The poster, titled "Comparison of Vitaros® Efficacy and Safety with Short-term and Longer Term Use," (Poster #35) authored by John P. Mulhall, M.D., Director of the Male Sexual and Reproductive Medicine Program at Memorial Sloan-Kettering Cancer Center, is scheduled to be on display June 21-22, 2013 from 9:00 AM to 5:00 PM local time.
"Vitaros® addresses a large population of ED patients who cannot or do not respond well to existing medications due to the systemic effects of PDE5 inhibitors, such as Viagra," said Rich Pascoe, Chief Executive Officer of Apricus Bio. "With its innovative, on-demand topical administration, and rapid onset in as little as five minutes, Vitaros® can safely improve erectile function in these patients with both short and longer term use."
This additional analysis of the Phase 3 data looked at the efficacy and safety of Vitaros® for short-term use (12 weeks; n=1,727) compared to longer-term use (n=1,161). The results found that, following 12 weeks of treatment, a statistically significant improvement in erectile function (EF) score was observed for the Vitaros® treatment group (1.6 for the 100 mcg dose group, 2.5 for the 200 mcg dose group, and 2.4 for the 300 mcg dose group) compared to the placebo group (-0.7) (p<0.001). A significantly greater proportion of patients receiving all dose levels of Vitaros® (100 mcg, 200 mcg, 300 mcg) reported improvement (up to 51%) in their erections compared to placebo.
With longer-term exposure, nearly all of the subjects (100%, 100%, and 88.2% in each of the 100mcg, 200mcg, and 300mcg dose groups respectively) had an improvement in EF score, and greater than 90% of the patients reported improvements in their erections. Compared to the end of the 12-week treatment, the mean IIEF score continued to improve for men choosing the 300 mcg dose level. The increased efficacy and the longer term safety evaluated in ED patients repeatedly exposed to Vitaros® illustrated that efficacy does not diminish with longer term use.
The majority of adverse events (AEs) were transient, and mild or moderate in intensity, and the incidence of AE reports decreased with repeated exposure. Relative to 12-week Vitaros® administration, longer term use of Vitaros® resulted in consistent, dose-dependent overall improvement in EF and fewer reports of transient urogenital adverse events.
The Company received approval effective May 31, 2013 of Vitaros® in Europe as a first line treatment for erectile dysfunction. The Company is currently working independently, as well as with its commercialization partners, Sandoz, Takeda, and Bracco, to obtain national phase approvals in France, Germany, Italy, UK, Ireland, Spain, The Netherlands, Sweden, Belgium and Luxembourg in order to make Vitaros® ready to launch in each of these territories across Europe. Vitaros® is also approved in Canada.
Vitaros® is a topically-applied cream formulation of alprostadil, a vasodilator, combined with our proprietary permeation enhancer DDAIP.HCL, which directly increases blood flow to the penis, causing an erection. Alprostadil is a widely accepted alternative to the PDE-5 inhibitors for difficult to treat patients, and Vitaros®, which was determined to be safe and effective by the European Health Authorities and previously by Health Canada, offers greater market opportunity due to its patient-friendly form versus other alprostadil dosage forms and also relative to oral ED products. With a market affecting nearly 150 million men worldwide and representing approximately $1 billion in revenue in Europe, Vitaros® represents a major market opportunity, particularly as a distinct product that addresses a significant underserved population.
About Apricus Biosciences, Inc.
Apricus Biosciences, Inc. (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 is now approved in Europe and Canada and will be commercialized by Apricus Bio's marketing partners which include, Abbott Canada, Takeda Pharmaceuticals International GmbH, Sandoz, and Bracco SpA. Femprox®, the Company's product candidate for the treatment of female sexual arousal disorder, has successfully completed a nearly 400-subject proof-of-concept study.
For further information on Apricus Bio, visit http://www.apricusbio.com.
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 product Vitaros® for erectile dysfunction , and product candidate Femprox® for Female Sexual Arousal Disorder among others; to have its product and product candidates receive additional patent protection and be approved by relevant regulatory authorities in Europe, the United States and Canada and in other countries; to successfully commercialize such product and product candidates and other NexACT® product candidates and drug delivery technology; to sell its oncology supportive care business or assets to a third party or parties; to cease funding to its French subsidiaries and to have such subsidiaries reorganize or liquidate successfully; 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.
Source:Apricus Biosciences, Inc.