FDA requests extra Cellegesic trial

US biopharmaceutical firm Cellegy Pharmaceuticals says that the Food and Drug Administration has issued an approvable letter in relation to its product Cellegesic (nitroglycerin ointment), which is intended for use in the treatment of the pain associated with chronic anal fissures. The FDA's letter requires that the Pennsylvania-headquartered firm conduct an additional clinical trial that demonstrates the product's efficacy at a statistically-significant level, which the agency believes has not been shown by the trials that form part of the current New Drug Application under its consideration.

Last year, Cellegesic was the subject of an FDA non-approvable letter (Marketletter January 3 & 10, 2005), after the agency raised questions about the results of several Phase III studies used by the original approval application. The firm submitted an amended NDA that contained new analysis to US regulators in April 2005, resulting in the product's review by the FDA's Cardio-Renal Advisory Committee in April of this year.

Cellergy's chairman and interim chief executive, Richard Williams, responding to the FDA's decision, said: "we believe that we achieved the requirements for Cellegesic to be approved. The FDA reached a different conclusion that the product was approvable, but requires another trial to demonstrate efficacy." He added that the firm was considering all available options and would schedule a meeting with the FDA in the near future.