Rectiv
Generic name: nitroglycerin
Treatment for: Anal Fissure and Fistula
Cellegesic Granted Priority Review by FDA
FDA Decision on Approvability Now Expected in January 2005
SOUTH SAN FRANCISCO, Calif., October 14, 2004 -- Cellegy Pharmaceuticals, Inc.(NASDAQ:CLGY) announced today that its New Drug Application (NDA) covering the use of Cellegesic (nitroglycerin ointment, 0.4%), for the treatment of pain associated with chronic anal fissure has been granted a "Priority Review" by the U.S. Food and Drug Administration (FDA). Cellegy submitted the Cellegesic NDA on June 30, 2004. The Company has been advised that the FDA will decide on approvability of the NDA in early January 2005.
David Karlin, M.D., Cellegy's Vice President of Clinical Research, said, "The FDA may grant a priority review of an NDA for a product determined to provide a significant therapeutic or public health advance. Priority Reviews are completed in 6 months compared to 10 - 12 months for a standard review. The granting of a Priority Review for Cellegesic recognizes that there is no FDA-approved product on the market for the treatment of chronic anal fissure."
K. Michael Forrest, Cellegy's President and CEO, said, "We are delighted to receive this accelerated review designation for Cellegesic and look forward to interacting with the Agency during the final stages of review."
Three double blind, placebo-controlled, Phase 3 studies comprise the NDA submission. The third study was conducted according to a "Special Protocol Assessment" (SPA) procedure that was agreed upon by Cellegy and the FDA. An SPA is intended to provide assurance that if the pre-specified primary endpoint is achieved and no unexpected, untoward effects are seen, the FDA will approve the product for commercial sale.
About Cellegy
Cellegy Pharmaceuticals is a specialty biopharmaceutical company that develops and commercializes prescription drugs for the treatment of gastrointestinal disorders, women's health care conditions, including sexual dysfunction, and certain cancers.
The Company's most advanced product, Cellegesic (nitroglycerin ointment) branded "Rectogesic" outside the United States, is approved in the United Kingdom for the treatment of pain associated with chronic anal fissures. Discussions with potential partners are underway and a launch of Rectogesic is expected in the first half of 2005.
The Company is also pursuing the use of Cellegesic for the treatment of hemorrhoids, as well as dyspareunia, a painful condition that prevents or inhibits sexual intercourse in more than 5 million women in the United States. Currently, there is no effective treatment for dyspareunia.
Posted: October 2004
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- FDA Issues Approvable Letter to Cellegy Pharmaceuticals for Cellegesic - July 10, 2006
- Cellegy Reports Review by Advisory Committee April 2006 - January 9, 2006
- Cellegy Reports Status of Response Date for FDA Review - June 30, 2005
- Cellegy Reports New FDA Target Response Date of June 15 - May 5, 2005
- Cellegy Responds to FDA Inquiries Concerning Cellegesic - April 18, 2005
- FDA Issues Not Approvable Letter for Cellegesic - December 23, 2004
- NDA for Cellegesic is Accepted for Review by FDA - September 1, 2004
- Cellegy Submits NDA for Cellegesic to Treat Chronic Anal Fissure Pain - June 30, 2004
Rectiv (nitroglycerin) FDA Approval History
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