RectivTreatment for Anal Fissure and Fistula
Update: Rectiv (nitroglycerin ointment) Now FDA Approved - June 21, 2011
Cellegy Reports New FDA Target Response Date of June 15
New Date Part of Continued Review by FDA of Cellegesic NDA
BRISBANE, Calif., May 05, 2005 -- Cellegy Pharmaceuticals, Inc. today announced that it has received a letter from the U.S. Food and Drug Administration indicating that the FDA is reviewing the Company's recently submitted amended New Drug Application (NDA) for Cellegesic (0.4% nitroglycerin ointment), for the treatment of pain associated with chronic anal fissure. The Company expects the agency to respond after its review by the FDA's target date of June 15, 2005.
As part of an ongoing dialog with the FDA following receipt of a Not Approvable letter in December 2004, the Company submitted a written response in April 2005 containing new analyses of data from its three Cellegesic Phase 3 trials.
The FDA's most recent letter indicated that under the Agency's procedural rules, the Company's resubmission is being accepted by the agency as a "complete, Class 1" response to the Agency's Not Approvable letter. A "Class 1 resubmission" is a resubmission that includes a minor re-analysis of data previously submitted to the application.
"We are very pleased with this action and look forward to the response by the FDA by June 15, 2005," said Richard C. Williams, Chairman and interim Chief Executive Officer of the Company.
Cellegy Pharmaceuticals is a specialty biopharmaceutical company that develops and commercializes prescription drugs for the treatment of women's health care conditions, including reduction in the transmission of HIV and sexual dysfunction, gastrointestinal disorders and certain cancers.
In October 2004, Cellegy acquired Biosyn, Inc., a privately held biopharmaceutical company in Huntingdon Valley, Pennsylvania. The addition of Biosyn, a leader in the development of novel microbicide gel products for contraception and the reduction in transmission of HIV in women, expands Cellegy's near term product pipeline and complements Cellegy's women's health care focus. Cellegy believes that Savvy (C31G vaginal gel), currently undergoing Phase 3 clinical studies in the United States and Africa, is one of the most clinically advanced products in development for the reduction in transmission of HIV.
Cellegesic, branded Rectogesic outside the United States, is approved in the United Kingdom for the treatment of pain associated with chronic anal fissures. Launch of Rectogesic in the United Kingdom through ProStrakan Group Limited, Cellegy's corporate partner, is expected in the first half of 2005. A similar formulation of Rectogesic is currently being sold in Australia, New Zealand, Singapore and South Korea. Fortigel branded Tostrex outside the United States, for the treatment of male hypogonadism, was approved by the Medical Products Agency (MPA) in Sweden in December 2004. ProStrakan will also distribute Tostrex in Sweden and the European Union. Approvals of Rectogesic and Tostrex by the other member states of the European Union will be pursued by Cellegy and ProStrakan through the Mutual Recognition Procedure.
Cellegy is developing two transdermal testosterone gel products: Fortigel, a testosterone replacement therapy for male hypogonadism and Tostrelle (testosterone gel) for the treatment of female sexual dysfunction in postmenopausal women.
Posted: May 2005
- ProStrakan Receives FDA Approval for Rectiv for the Treatment of Moderate to Severe Pain Associated With Chronic Anal Fissures - June 22, 2011
- 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 Responds to FDA Inquiries Concerning Cellegesic - April 18, 2005
- FDA Issues Not Approvable Letter for Cellegesic - December 23, 2004
- Cellegesic Granted Priority Review by FDA - October 14, 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