- A Phase 2a study assessing the safety, tolerability and pharmacodynamics of Apricus Biosciences' (APRI +2.6%) RayVa (alprostadil topical cream) in scleroderma patients with Raynaud's disease showed no significant issues in any dosing cohort.
-
Scleroderma is an autoimmune disorder characterized by hardening of the skin. Raynaud's is a condition characterized by numbness in the fingers and toes caused by the narrowing of smaller arteries that supply blood to the skin. Scleroderma affects ~100K Americans. About 90% also suffer from Raynaud's.
- The 35-subject, randomized, double-blind, placebo-controlled trial was based on an experimental design wherein participants were exposed to a cold challenge to assess changes in blood flow and skin temperature as a result of vasoconstriction, characteristic of Raynaud's. Each was then exposed to placebo or one of thee doses of RayVa.
- A Phase 2 trial assessing RayVa's efficacy in an at-home dosing setting is planned for 2016.