SAN DIEGO, May 21, 2012 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. ("Apricus Bio" or the "Company") (Nasdaq:APRI) (http://www.apricusbio.com) announced today that the United States ("U.S.") Food and Drug Administration ("FDA") has granted the Company's request for a Type C meeting to obtain regulatory guidance from the agency for Femprox®, the Company's topical alprostadil cream for the treatment for female sexual arousal disorder (FSAD). The meeting is expected to take place in late July 2012 and the purpose of the meeting is to obtain feedback from the agency regarding the suitability of Femprox®'s clinical, preclinical, and quality control data to support a New Drug Approval ("NDA") in the U.S.
Apricus Bio expects to meet with the Reproductive and Urologic Products Division of the Office of New Drugs within the Center for Drug Evaluation & Research (CDER) within FDA. The Study Endpoints and Labeling Division within CDER also will be consulted as part of the meeting. Femprox® is a topically applied formulation of 0.4% alprostadil delivered using Dodecyl 2-(N, N dimethylamino)-propionate (DDAIP), Apricus Bio's proprietary drug delivery technology. The Company believes that Femprox® is further along in development than any other product for FSAD and is the only product candidate to have successfully completed a near 400 subject Phase III clinical trial, a trial which achieved statistical significance in both its primary and secondary endpoints.
"We look forward to working with the Reproductive and Urologic Products Division of the FDA, and gaining clarity regarding the development path forward for Femprox® in the U.S.," said Bassam Damaj, PhD, President and Chief Executive Officer of Apricus Bio. "We believe Femprox® is a unique treatment option for FSAD, not only because of its topical delivery, local mechanism of action, and its safety profile, but also because of the high response rate and safety profile seen in the clinical trials. Upon completion of this meeting we believe we will be one step closer to filing for this product in the U.S. and bringing a new treatment option to women suffering from FSAD."
Apricus Bio was recently granted a Pre-New Drug Submission (Pre-NDS) meeting for Femprox® with Health Canada which is expected to take place on July 17, 2012, and the Company is also working with its European agents to conduct similar meetings with various European health agencies.
About Femprox®
Femprox® is a 0.4% alprostadil cream intended for the treatment of FSAD. 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 Phase III study in China. To the Company's knowledge, no product is currently approved to treat FSAD, a persistent or recurring inability to attain, or maintain adequate sexual excitement, causing personal distress. Estimates of the FSAD market size put it on par with erectile dysfunction in males, and possibly larger.
Femprox® exerts a relaxant effect on vulvar and clitoral blood vessels in women, leading to increased blood flow. This leads to pelvic engorgement and enhanced secretion activity of the vulvar epithelium. The resultant increase in lubrication and sensory feedback due to pelvic engorgement is believed to produce a clinically significant increase in sexual arousal in women with FSAD. Femprox® enables a rapid permeation of blood deep into the target tissues thus enabling a new pharmacotherapy for the treatment of FSAD through increasing the blood flow to tissue.
About Apricus Biosciences, Inc.
Apricus Bio is a San Diego-based revenue-generating pharmaceutical company, with commercial products and a broad pipeline across numerous therapeutic classes.
Revenues and growth are driven from the sales of the Company's commercial products through its Apricus Pharmaceuticals USA, Inc. and NexMed (USA), Inc. subsidiaries and through out-licensing in certain territories of its product pipeline and NexACT® technology.
Apricus Bio's current NexACT® pipeline includes Vitaros®, approved in Canada for the treatment of erectile dysfunction, as well as compounds in development from pre-clinical through pre-registration currently focused on Sexual Dysfunction, Oncology, Dermatology, Autoimmune, Pain, Anti-Infectives, Diabetes and Consumer Healthcare.
Apricus Bio currently markets Totect® (dexrazoxane HCl), the only drug approved in the US for the treatment of anthracycline extravasation. The Company also plans to market in the U.S. or certain other countries the following products: (a) Granisol® (granisetron HCI) oral solution, the only FDA-approved, oral, ready-to-use liquid solution of granisetron, (b) Aquoral™, an FDA-cleared, prescription-only spray for the treatment of Xerostomia (the medical term for dry mouth due to a lack of saliva) and (c) NitroMist™ (nitroglycerin sublingual spray), an FDA-approved nitrate vasodilator indicated for acute relief of an attack or acute prophylaxis of angina pectoris (chest pain) due to coronary artery disease (narrowing of the blood vessels that supply blood to the heart).
The Company also expects to develop and/or acquire and then bring to market additional pharmaceutical products in areas of care that will benefit patient needs worldwide.
For further information on Apricus Bio, visit http://www.apricusbio.com, and for information on its subsidiary please visit http://www.nexmedusa.com. You can also receive information at http://twitter.com/apricusbio.
Apricus Bio's Forward-Looking Statement Safe Harbor
Statements under the Private Securities Litigation Reform Act, as amended: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risks and uncertainties that may individually or mutually impact the matters herein described for a variety of reasons that are outside the control of the Company, including, but not limited to, its ability to further develop its products and product candidates, to have its products and product candidates such as Femprox® receive patent protection and be approved by relevant regulatory authorities, to successfully commercialize such products as Totect® , Granisol® , Aquoral™ and NitroMist™ and Vitaros® for erectile dysfunction and NexACT® product candidates and drug delivery technology and to achieve its development, commercialization and financial goals. Readers are cautioned not to place undue reliance on these forward-looking statements as actual results could differ materially from the forward-looking statements contained herein. 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. Copies of these reports are available from the SEC's website or without charge from the Company.