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Article: Cellegy Resurrects Cellegesic, Set To Begin Third Phase III.
- Article from:
- BIOWORLD Today
- Article date:
- November 4, 2009
CopyrightCOPYRIGHT 2009 A Thomson Healthcare Company. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Staff Writer
Rising from the ashes of a new drug application withdrawal, Cellegy Pharmaceuticals Inc. is resurrecting the development of Cellegesic, its drug for chronic anal fissures.
In April, Cellegy withdrew its NDA after the FDA advised it that approval was unlikely, causing the company's stock to plummet more than 50 percent on the day the news was released.
But following a series of meetings with the FDA, South San Francisco-based Cellegy is progressing with an additional Phase III trial in an attempt to obtain approval for the nitroglycerin ointment designed to treat pain caused by chronic anal fissures. The trial is structured to test ...