RayVa™ or alprostadil topical cream is being developed to treat the symptoms associated with Raynaud's Phenomenon secondary to systemic sclerosis. The active pharmaceutical ingredient in RayVa™ is alprostadil and, with DDAIP.HCl, allows local delivery of the vasodilator to the site of action.

What is Raynaud’s phenomenon?

First described in the 1800’s, it is the transient loss of blood flow to the extremities, however, the primary cause remains unexplained.

Raynaud’s phenomenon (RP) is fairly common with a reported prevalence up to 5% with a disproportionately higher number of women affected. Triggers for an Raynaud’s phenomenon attack include cold temperatures, caffeine, smoking or emotional stress. Attacks are the result of reduced blood flow to areas including fingers, toes, nose and ears. Depending upon the severity, the affected areas may turn pale or blue followed by redness once the blood flow is restored. Accompanying the changes in blood flow are pain and tingling sensations.

Raynaud’s phenomenon is described as either primary or secondary. Primary Raynaud’s is often first recognized in younger individuals that have a family history and the attacks tend to be mild. Individuals with secondary Raynaud’s are older and often have autoantibodies or connective tissue disease, including scleroderma, and their attacks are more intense and painful. Repeated episodes may be associated with ulceration and changes in the appearance of the affected areas. While the blood vessels appear normal in individuals with primary Raynaud’s, the blood vessels are narrowed and irregular with secondary Raynaud’s.

Individuals incorporate lifestyle changes including wearing gloves, smoking cessation and limiting stress to prevent triggering Raynaud’s phenomenon attacks. Currently, there are no approved treatments for Raynaud’s phenomenon in the United States for primary or secondary Raynaud’s.