Rectiv

Treatment for Anal Fissure and Fistula

Update: Rectiv (nitroglycerin ointment) Now FDA Approved - June 21, 2011

FDA Issues Approvable Letter to Cellegy Pharmaceuticals for Cellegesic

HUNTINGDON VALLEY, Pa., July 10, 2006 -- Cellegy Pharmaceuticals, Inc. announced that it received late afternoon on Friday, July 7 a communication from the U.S. Food and Drug Administration in the form of an Approvable Letter for its product, Cellegesic (nitroglycerin ointment). The letter stated, however, that before the company's New Drug Application (NDA) may be approved and the product approved for marketing, Cellegy must conduct another clinical trial to demonstrate efficacy at a level deemed statistically significant by the agency. The letter indicated that the agency was requiring an additional study because it believed the results of the three trials conducted to date did not provide substantial evidence that the drug is effective, and provided a number of comments on the results previously presented by Cellegy and recommendations concerning the design and protocol of the additional required study. Cellegesic, for the treatment of anal fissures, was the subject of an FDA Not Approvable letter in December 2004. An amended NDA, containing new analyses, was resubmitted to the FDA in April 2005, which resulted in a review by the FDA's Cardio-Renal Advisory Committee in April 2006. As previously reported, the Advisory Committee's final vote was six members of the Committee for "Approval" of Cellegesic and six for "Approvable pending another study of effectiveness." There were no votes for "Not Approvable." Cellegesic has been under review at the FDA since then.

Richard C. Williams, Cellegy's Chairman and interim CEO, stated, "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. We are carefully considering all of our options and will be scheduling a meeting with the FDA."

Posted: July 2006

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