Heart Health Articles

Apricus Bio Receives FDA Guidance On Phase 3 Study Design For RayVa™ Treatment For Raynaud's Syndrome, Secondary To Scleroderma

April 17, 2017

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 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.

Raynaud's syndrome is a disorder in which the fingers or toes (digits) suddenly experience decreased blood circulation, and is characterized by color changes of the skin of the digits upon exposure to cold or emotional stress. Patients with Raynaud's syndrome secondary to scleroderma typically have more severe complications, including digital ulcers. The prevalence of Raynaud's syndrome in the general U.S. population is estimated to vary from 4-15%. Females are seven times more likely to develop the condition than men. For most patients, Raynaud's syndrome is an inconvenience. However, chronic recurrent cases of Raynaud's syndrome can result in atrophy of the skin, subcutaneous tissues and muscle. In rare cases, it can cause ulceration and ischemic gangrene.

Commenting on today's news, Bassam Damaj, Ph.D., President and Chief Executive Officer of Apricus Bio, stated, "We are currently in the process of completing and submitting the final protocol for this trial. We believe that our success in obtaining approval to submit a Phase 3 SPA protocol to the agency further demonstrates the favorable safety profile of NexACT as observed in our clinical trials conducted to date. We now look forward to pursuing and commencing discussions for potential development partners for RayVa in the months to come with the objective of finding a development partner who will help to fund the expected costs of the RayVa study."

Apricus Biosciences