Cellegy Pharmaceuticals has announced receipt of a communication from the U.S. Food and Drug Administration in the form of a Not Approvable Letter for its product Cellegesic(TM) (nitroglycerin ointment).
Cellegesic was the subject of an NDA that was filed with the FDA for the treatment of pain associated with chronic anal fissure. In October the FDA granted the application a Priority Review status.
K. Michael Forrest, Cellegy's President and CEO, stated, "We believe that our third Phase 3 trial achieved the requirements for approval of Cellegesic as agreed with the FDA under the provisions of a Special Protocol Assessment. In addition, two previous Phase 3 trials included in the NDA were supportive of approval. The FDA reached a different conclusion and has raised several issues that were not part of the agreed upon approval criteria. We are evaluating the FDA's letter and will carefully consider all of our options."
"We are disappointed that the FDA chose to take this action on what we consider to be a safe and effective product that could provide relief to hundreds of thousands of people suffering from this very painful condition," said David A. Karlin, M.D., Cellegy's Vice President, Clinical Research.