Apricus Biosciences, Inc. (NASDAQ:APRI) Files An 8-K Other EventsItem 8.01Other Events.
On February 15, 2018, Apricus Biosciences, Inc. (the “Company”) was notified by the U.S. Food and Drug Administration (“FDA”) that the FDA has issued a complete response letter (“CRL”) for the New Drug Application (“NDA”) of Vitaros™ (alprostadil, DDAIP.HCl), a topical cream for the treatment of erectile dysfunction. The CRL indicates that the FDA cannot approve the NDA for Vitaros in its present form, identifying deficiencies related to Chemistry, Manufacturing and Control (CMC) and certain safety concerns specific to the 2.5% concentration of DDAIP.HCl contained in the current formulation. The Company is evaluating the deficiencies identified in the CRL and potential path forward.
Forward Looking Statements
This report contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act, as amended. Statements in this report that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things: the timing of any clinical and non-clinical studies to address the FDA’s concerns and whether the results of such studies would be sufficient to overcome the deficiencies raised in the CRL; the timing of any interaction with Allergan; and the timing and results of the Company’s evaluation on the path forward for the company. Actual results could differ from those projected in any forward-looking statements due to a variety of reasons that are outside of the Company’s control, including, but not limited to: the Company’s financial position and need for additional capital to fund its operations, which may be adversely impacted if the Company is unable to maintain the continued listing of its common stock on the Nasdaq stock market; the Company’s ability to address any conditions for approvability of Vitaros raised by the FDA in the CRL; the risks of any additional adverse safety or other data arising from the sales and use of Vitaros in certain countries in Europe and elsewhere; competition in the ED market; and other risks identified by the Company in its reports filed with the Securities and Exchange Commission (SEC). These forward-looking statements are made as of the date of this report, and the Company 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 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.
About Apricus Biosciences, Inc. (NASDAQ:APRI)
Apricus Biosciences, Inc. is a pharmaceutical company, which develops pharmaceutical products. The Company primarily focuses on the development and commercialization of products and product candidates in the areas of urology and rheumatology. The Company’s drug delivery technology is a permeation enhancer called NexACT. The Company has over two product candidates in Phase II development, fispemifene for the treatment of symptomatic male secondary hypogonadism and RayVa for the treatment of Raynaud’s phenomenon, secondary to scleroderma. The Company has a commercial product, Vitaros for the treatment of erectile dysfunction (ED), which is in development in the United States, approved in Canada and marketed throughout Europe.