Apricus Biosciences Confirms Clinical Strategy for Its Novel Treatment for Symptomatic Secondary Hypogonadism Fispemifene
SAN DIEGO, 2015-12-01 18:49 CET (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today reaffirmed its regulatory and clinical strategy for the development of fispemifene in response to the Complete Response Letter issued to Repros Therapeutics Inc. (RPRX) by the Food and Drug Administration (FDA). Apricus is developing fispemifene, a SERM (selective estrogen receptor modulator) for the treatment of sexual dysfunction in men with symptomatic secondary hypogonadism.
"Apricus has worked with the FDA to develop our clinical strategy for fispemifene," commented Barbara Troupin, M.D., Chief Medical Officer of Apricus. "For our ongoing Phase 2b study, we developed a protocol that addresses the FDA's suggestions for clearly defining the target patient population, designating clinical benefits which are both important and relevant to the target population, and using symptom-based endpoints aimed at assessing those specific benefits in this population. As a result, we believe we are well-positioned to bring a first-in-class SERM product to the U.S. market."
Apricus expects to report results from the Phase 2b fispemifene trial in the first quarter of 2016 and, if successful, will continue to work closely with the FDA to plan registration studies of fispemifene in 2016.
Phase 2b Trial Design
The Phase 2b proof-of-concept clinical trial is a randomized, double-blind, placebo-controlled, parallel arm, multi-center study in up to 160 hypogonadal men aged 18 to 64 who present with sexual dysfunction related to secondary hypogonadism, or low levels of testosterone. The study will evaluate the safety and tolerability of oral fispemifene, and will assess the effects of treatment on the sexual symptoms using patient reported outcome (PRO) endpoints. The study will also assess relevant pharmacodynamic and pharmacokinetic parameters to evaluate the ability of fispemifene to endogenously increase the serum testosterone level.
About Apricus Biosciences, Inc.
Apricus Biosciences, Inc. (APRI) is a biopharmaceutical company advancing innovative medicines in urology and rheumatology. Apricus recently completed enrollment in its 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 has completed a Phase 2a trial for RayVa™, its product candidate for the treatment of the circulatory disorder Raynaud's phenomenon, and plans to conduct additional clinical trials in patients with Raynaud's phenomenon secondary to scleroderma. 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 recently in-licensed the U.S. development and commercialization rights for Vitaros from Allergan. Apricus' marketing partners for Vitaros include Laboratoires Majorelle, Bracco S.p.A., Hexal AG (Sandoz), Takeda Pharmaceuticals International GmbH, Recordati Ireland Ltd. (Recordati S.p.A.), Ferring International Center S.A. (Ferring Pharmaceuticals) and Mylan NV. Apricus' second-generation room temperature Vitaros is currently 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: Apricus' development activities for fispemifene, including the Phase 2b protocol addressing the FDA's suggestions for such trial, a development pathway and Apricus' ability to move fispemifene into later stage clinical development, and the effects of Repros Therapeutics's complete response letter on such clinical development; the timing and results of the Phase 2b clinical trial to evaluate fispemifene for the treatment of symptomatic male secondary hypogonadism; the potential timing of a competitor's SERM product being approved by the FDA; and the potential timing of any new drug application, or NDA, submission by Apricus. Actual results could differ from those projected in any forward-looking statements due to a variety of reasons that are outside the control of Apricus, including, but not limited to: the timing and results of the ongoing Phase 2b clinical trial of fispemifene, Apricus' ability to receive feedback from the FDA on the development of fispemifene and, based on such feedback, further develop fispemifene for the treatment of symptomatic male secondary hypogonadism or other urological conditions, as well as the timing of such events; Apricus' ability to carry out further clinical studies for fispemifene, as well as the timing and success of the results of such studies; issues raised by the FDA in Repros Therapeutics;s complete response letter affecting the development of and regulatory approval for fispemifene; Apricus' ability to raise additional funding that it may need to continue to pursue its commercial and business development plans; and Apricus' ability to obtain the requisite governmental approval for fispemifene. 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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