Drugmaker Auxilium Pharmaceuticals Inc. said Wednesday a midstage study of its drug candidate Xiaflex for the treatment of Peyronie's disease showed statistically significant improvements.
The Malvern, Pa. company expects to meet with the Food and Drug Administration in the second quarter of 2010 to discuss a late-stage study that could start later next year.
Peyronie's disease involves the development of plaque or scar tissue in the shaft of the penis that causes pain and forces it to arc or bend when erect.
Auxilium said a study involving 145 patients showed that the drug was well tolerated and found a statistically significant change compared to a placebo in improvement in penile curvature.
Auxilium also is studying Xiaflex as a treatment for Dupuytren's contracture, a condition related to diabetes that causes the tendons of the hand to shorten, making the fingers curve inward.
The company's shares fell $1.16, or 3.6 percent, to $31.34 at the start of trading Wednesday.