SAN DIEGO--(BUSINESS WIRE)--Apricus Biosciences (“Apricus Bio”) (Nasdaq: APRI), backed by a revenue-generating CRO business and seeking to leverage its multi-route NexACT® drug delivery technology and internal pipeline through out-licensing partnerships, announced today that the U.S. Food and Drug Administration (FDA) has provided guidance on the clinical requirements for assessing the approvability of RayVa for the treatment of Raynaud’s syndrome secondary to scleroderma. The Company met with FDA officials, including the Director of the Cardiovascular Division, in an effort to gain a clear and defined clinical path to support an application for the approval of RayVa. In the meeting, the FDA officials agreed with the Company on the clinical endpoints and agreed to receive a Phase 3 Special Protocol Assessment (“SPA”) clinical trial protocol for review. The Company is currently working to finalize and submit the Phase 3 SPA protocol, which the FDA will then have 30 days to review before human clinical studies are allowed to commence.
