Zoraxel is a developmental stage drug for sexual dysfunction that directly modulates the sexual activity control center in the brain. Zoraxel enhances the action of serotonin and dopamine, brain signaling molecules that play a key role in three phases of male sexual activity: arousal, erection and release. Zoraxel is the first erectile dysfunction (ED) therapeutic to affect all three of these phases. Unlike PDE-5 inhibitors (Viagra, Cialis and other ED drugs) that only address blood flow issues and thus peripherally acting, Zoraxel is centrally acting in the brain affecting all three functions of male sexual activity. Roughly half the patients who suffer from sexual dysfunction do not respond to Viagra.
· Advance clinical development of Zoraxel for sexual dysfunction. In the first half of 2010, Rexahn expects to submit a protocol to the FDA for a Zoraxel Phase IIb clinical study for male sexual dysfunction. In May 2009, Rexahn announced data from a Phase IIa clinical study demonstrating Zoraxel’s potential as an effective, new treatment of erectile dysfunction (ED) and as a safer alternative to currently marketed drugs for ED. The double blind, randomized, placebo-controlled, dose ranging study found that human subjects treated with Zoraxel showed improved erectile function and quality of life during the 8-week treatment period.