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NetworkNewsBreaks – Apricus Biosciences, Inc. (APRI) Intends to Re-submit Vitaros NDA Following FDA Feedback; Shares Sink

Company: Apricus Biosciences, Inc. (APRI)
Category: News

Apricus Biosciences (NASDAQ: APRI) dropped 12% in mid-morning trade after announcing that it has received feedback from the FDA regarding the  previously announced Type B Meeting request to confirm Apricus’ strategy for addressing the deficiencies contained in the 2008 CRL.  The FDA’s feedback suggested additional analysis of existing clinical and non-clinical data, though it did not indicate that new clinical studies would be required for re-submission. Importantly, the FDA determined that Vitaros, under current regulations, is now considered a drug-device combination. Apricus said it believes there is “a viable regulatory pathway for resubmission of the Vitaros NDA in the U.S.” and that it intends to re-submit the NDA as soon as possible in 2017.

To view the full press release, visit: http://nnw.fm/5a6BE

About Apricus Biosciences, Inc.

Apricus Biosciences, Inc. (APRI) is a biopharmaceutical company advancing innovative medicines in urology and rheumatology. Apricus’ commercial product, Vitaros®, for the treatment of erectile dysfunction, is approved in Canada and certain countries in Europe, Latin America and the Middle East and is being commercialized in several countries in Europe. In September 2015, Apricus in-licensed the U.S. development and commercialization rights for Vitaros from Allergan. Apricus’ marketing partners for Vitaros include Recordati Ireland Ltd. (Recordati), Ferring International Center S.A. (Ferring Pharmaceuticals), Laboratoires Majorelle, Bracco S.p.A., Mylan NV and Elis Pharmaceuticals Ltd. Apricus currently has one active product candidate, RayVa™, its product candidate for the treatment of the circulatory disorder Raynaud’s phenomenon. For more information visit www.apricusbio.com

About NetworkNewsBreak

NetworkNewsBreak (NNB) provides a rapid summary of corporate news that caught the attention of NetworkNewsWire (NNW). NNB keeps you up-to-date on active US Public Companies complementary to NNW’s broader scope as a provider of news aggregation and syndication, enhanced press release services and a full array of social communication solutions. As a multifaceted financial news and distribution company with an extensive team of journalists and writers, NNW is uniquely positioned to best serve private and public companies who need to reach a wide audience of investors, consumers, journalists and the general public. NNW has an ever-growing distribution network of more than 5,000 key syndication outlets across the country. By cutting through the overload of information in today’s market, NNW brings its clients unparalleled visibility, recognition and brand awareness. NNW is where news, content and information converge.

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