Uplifting data for Rexahn’s Zoraxel
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Rexahn Pharmaceuticals announces positive preliminary Phase IIa data for its orally administered erectile dysfunction tablet Zoraxel. The double blind, randomized, placebo-controlled, dose ranging study found Zoraxel improves erectile function as measured by changes over the International Index of Erectile Function baseline score within the 8-week treatment period. Firm reports that Zoraxel, which is a centrally acting, dual enhancer of neurotransmitters in the brain, appears to lack the severe side effects - including priapism and severe hypotension - associated with standard of care phosphodiesterase (PDE-5) inhibitors. Rexahn will have an uphill battle against the widely known drugs, but believes "the future of ED treatment lies in compounds that act on the brain (central nervous system) and address the underlying condition," as opposed to PDE-5 agents that only target end organ function