Apricus Biosciences Inc. (APRI) announced that U.S. Food and Drug Administration 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 or 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 or NDA in the U.S.
Apricus Bio said it 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, the company said.
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.
Apricus Bio said it 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.
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