Press Releases
November 16, 2004
Xanodyne Announces Fast Track Status of its Drug to Treat Heavy Menstrual Bleeding
FOR IMMEDIATE RELEASE
Florence, KY – November 16, 2004 – Xanodyne Pharmaceuticals, Inc. announced today that its product to treat heavy menstrual bleeding, known as XP12B, was granted Fast Track Product status by FDA. The Fast Track program at FDA is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions, and that demonstrate the potential to address unmet medical needs.
“Heavy menstrual bleeding is a significant problem and its treatment represents an unmet need for millions of women in the United States,” said William Nuerge, CEO of Xanodyne. “There are currently no pharmaceutical products approved in the U.S. for the treatment of this condition. We look forward to bringing this first-in-class product to the market to address the healthcare needs of women. This project was identified and developed in-house, and its recent granting of Fast Track status is a testament to the quality of the Xanodyne product development team.”
“XP12B is a significant project for furthering our objective to develop innovative products for women’s health,” explained Jim Young, PhD, Vice President of Product Development and Professional Services. “We are pleased that this project received Fast Track status and anticipate moving rapidly through our Phase 3 program which has already begun.”
Margery L. Gass, MD, Professor of Obstetrics and Gynecology, University of Cincinnati said, “I am pleased that Xanodyne is developing this important medical therapy for menorrhagia (heavy menstrual bleeding). Upon approval of the product, physicians and patients will have a new therapeutic option for treating this condition.”
Xanodyne Pharmaceuticals, Inc. is a privately owned, fully integrated, branded specialty pharmaceutical company focusing on innovative products in the therapeutic areas of women’s health, urology and pain management. The company, located in the greater Cincinnati area, has a nationwide sales force and currently markets numerous pharmaceutical products including Amicar®, DexAlone®, Duet® by StuartNatal®, Duet® DHA by StuartNatal®, Hycet™, Lucidex®, Stuart Prenatal®, and Urimax®. Xanodyne also has a number of novel new products under development.
For more information, visit the Xanodyne website at www.xanodyne.com.
CONTACT:
James L. Young, Ph.D.
Xanodyne Pharmaceuticals
859-371-6383