Zoraxel the Next ED Treatment?
Rexahn Pharmaceuticals, Inc., the manufacturer of a new potential erectile dysfunction drug called Zoraxel, has just applied for a Phase IIb protocol with the Food and Drug Administration (FDA) for clinical trials.
For these trials Rexahn has formed SAB (Urology Scientific Advisory Board) which will design and oversee the clinical trials. The members of this board consist of in no particular order:
• Patrick C. Walsh – Professor of Urology at the John Hopkins University
• Arthur L. Burnett, MD, MBA, FACS
• Culley C. Carson III, MD, FACS, Rhodes Distinguished Professor and Chief of Urology at the University of North Carolina
Data from Phase IIa reported that males treated with Zoraxel showed significant improvements in erectile function as well as quality of life measurements. The report also shows the treatments to be safe, and was well tolerated by the test subjects, with no serious adverse side affects. This past study was concluded in May of 2009. For these reasons Rexahn has decided to continue with Phase IIb.
Phase IIb will study the continued success on more than 200 male subjects aged 18 to 65 in a 12 week study on ED. The 12 week study will consist of a double blind, placebo controlled, randomized study. The study will also include quality of life study endpoints, the Sexual Encounter Profile survey (SEP), and the International Index of Erectile Function IIEF).
Rexahn Chief Executive Officer, Dr. Chang Ahn said “The progression of Zoraxel’s clinical program is very encouraging.” Rexahn believes the future of ED treatment is not by targeting the end organ erectile function, but rather the ED treatment lies in the modification of the central nervous system which in affect modifies the condition. “Zoraxel has the potential to be the first drug capable of this action and to establish a new standard of care for erectile dysfunction.”
Rexahn Pharmaceuticals currently has 3 promising first in class drugs in phase IIb clinical trials. Archexin , Serdaxin , and Zoraxel. Rexahn currently markets therapeutics for CNS Disorders, sexual dysfunction, cancer, and other unmet medical needs. For more information on this and it’s other research and development programs on nano medicines please visit www.rexahn.com.