SAN DIEGO, Calif., Aug. 19, 2015 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. ("Apricus" or the "Company") (Nasdaq:APRI) (http://www.apricusbio.com) announced today that it re-affirms its intent to seek a global development partner for Femprox®, the Company's topical alprostadil cream for the treatment of female sexual interest/arousal disorder ("FSIAD"). Femprox is a topically applied formulation of 0.4% alprostadil delivered using Dodecyl 2-(N, N dimethylamino)-propionate (DDAIP), Apricus' proprietary drug delivery technology. The Company has completed a near 400 subject proof-of-concept clinical trial on Femprox, which achieved statistical significance in both its primary and secondary endpoints.
"Given the recent FDA approval of Sprout Pharmaceuticals, Inc.'s flibanserin for female sexual dysfunction, Apricus now believes that a potential regulatory path exists in the U.S. for Femprox," said Richard Pascoe, Apricus' Chief Executive Officer. "We will immediately initiate a disciplined partnering process to identify potential licensees for the global development and commercialization rights for Femprox with the goal of maximizing our return on investment for the potential benefit of shareholders."
Femprox® is a 0.4% alprostadil cream intended for the treatment of FSIAD. To date, Apricus Bio has completed nine clinical studies with Femprox, including one, 98-subject Phase II study in the U.S. and a near 400-subject proof-of-concept study in China. 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 an increase in sexual arousal in women with FSIAD.
About Apricus Biosciences, Inc.
Apricus Biosciences, Inc. (Nasdaq:APRI) is a biopharmaceutical company advancing innovative medicines in urology and rheumatology. Apricus has initiated a Phase 2b trial for fispemifene, a selective estrogen receptor modulator for the treatment of symptomatic male secondary hypogonadism, and plans to conduct additional studies in other urological conditions. Apricus recently completed enrollment in a Phase 2a trial for RayVa™, its product candidate for the treatment of the circulatory disorder Raynaud's phenomenon. Apricus' lead commercial product, Vitaros®, for the treatment of erectile dysfunction, is approved in Europe and Canada and is being commercialized in several countries in Europe. Apricus' marketing partners for Vitaros include Mylan NV, Takeda Pharmaceuticals International GmbH, Hexal AG (Sandoz), Recordati Ireland Ltd. (Recordati S.p.A.), Bracco S.p.A. and Laboratoires Majorelle. Apricus' second-generation room temperature Vitaros is under development.
For further information on Apricus, visit http://www.apricusbio.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act, as amended. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things: references to the timing and success of any development plan and the regulatory pathway for Femprox® and Apricus' intent to partner with a third-party to develop Femprox. Actual results could differ from those projected in any forward-looking statements due to a variety of reasons that are outside of Apricus' control, including, but not limited to: Apricus' ability to partner with a third-party to develop Femprox on favorable terms, or at all; potential changes in regulatory approval requirements; dependence on any partner for key development activities, and the potential that a partner will have limited resources or otherwise not prioritize Femprox relative to its other development priorities; and the results of any additional clinical trials on Femprox or other drug candidates targeting FSIAD. These forward-looking statements are made as of the date of this press release, and Apricus assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements. Readers are urged to read the risk factors set forth in Apricus' 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 at www.sec.gov or without charge from Apricus.
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