March 1, 2006

An FDA advisory panel this spring will discuss Cellegy Pharmaceuticals' new drug application (NDA) for the pain-relief gel Cellegesic, which has a proposed indication of relieving pain associated with anal fissures.

The scheduled April 25 meeting of the agency's Cardiovascular and Renal Drugs Advisory Committee comes roughly five years after Cellegy first submitted its application for the drug.

In 2002, Cellegy announced it would conduct a third Phase III trial for Cellegesic (nitroglycerin ointment) to win FDA approval. The drugmaker filed its NDA for Cellegesic in June 2001, but withdrew it in April 2002 after the FDA raised concerns about the company's statistical analysis methods and whether Cellegy had specified all details of its methodology prior to the trial.

Cellegy received marketing approval for the product in the U.K. in 2004.

On April 26, the Cardiovascular and Renal Drugs Advisory Committee is scheduled to discuss the FDA's draft recommendations for relabeling antihypertensive drugs to respond to outcome claims. The discussion follows a June 15, 2005, meeting in which the panel discussed proposed versions of class labeling for antihypertensive drugs based on the proximity of the products' data to outcome trials.