Vitaros U.S. NDA Re-Submission on Track for Third Quarter 2017
SAN DIEGO, May 04, 2017 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today reported that the Vitaros drug-device combination human factor testing study required by the Food and Drug Administration (FDA) is underway.
“In November of 2016, the FDA designated Vitaros as a drug-device combination and required Apricus to provide additional information regarding the proper use of the applicator in the planned NDA re-submission,” stated Richard W. Pascoe, Chief Executive Officer. “We have since confirmed the necessary regulatory requirements for a drug-device combination product and have initiated the required human factors study which we believe is in accordance with the FDA guidance. We expect this study will be completed in the second quarter of this year and the results will be incorporated into our planned Vitaros NDA re-submission, which remains on track for the third quarter of this year.”
About Apricus Biosciences, Inc.
Apricus Biosciences, Inc. (APRI) is a biopharmaceutical company advancing innovative medicines in urology and rheumatology. Apricus has two product candidates currently in development. Vitaros is a product candidate in the United States for the treatment of erectile dysfunction, which is in-licensed from Warner Chilcott Company, Inc., now a subsidiary of Allergan plc (Allergan). RayVa is our product candidate in Phase 2 development for the treatment of the circulatory disorder Raynaud’s phenomenon, secondary to scleroderma, for which Apricus owns worldwide rights.
For further information on Apricus, visit http://www.apricusbio.com.
Vitaros™ is Apricus’ trademark in the United States, which is pending registration and subject to the agreement with Allergan. Vitaros® is a registered trademark of Ferring International Center S.A. in certain countries outside of the United States. RayVa™ is Apricus’ trademark, which is registered in certain countries throughout the world and pending registration in the United States.
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: the timing of the completion of the drug-device combination human factor study; the ability of the drug-device combination study to provide results which can be incorporated into Apricus’ planned Vitaros NDA resubmission; and the timing of regulatory submission and approval of Vitaros in the United States, if any. 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 protocol for the drug-device combination human factor study may not be in compliance with the FDA guidance; the study may produce negative results; Apricus’ may not be able to obtain FDA and other requisite governmental approval for Vitaros; Apricus’ ability to further develop Vitaros, such as delivery device improvements, may be limited or unsuccessful; Apricus’ ability to carry out further clinical studies for Vitaros, if required, as well as the timing and success of the results of such studies; Apricus’ ability to raise additional funding that it may need to continue to pursue its commercial and business development plans; and market conditions. 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.
The Trout Group