Apricus Biosciences Granted Regulatory Meeting With FDA for Femprox(R) for the Treatment of Female Sexual Arousal Disorder
Apricus Biosciences (Nasdaq: APRI) 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.
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