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May 01, 2006
 |  BioCentury  |  Product Development

Cellegesic splits its panel

A day short of four years after it withdrew its second NDA for Cellegesic nitroglycerin ointment to treat anal fissure pain, Cellegy Pharmaceuticals Inc. convinced half of the members of an advisory committee that FDA should approve the product. The other half said the company should go back to the clinic.

Much of last week's Cardiovascular and Renal Drugs Advisory Committee meeting was a rehearsal of the four years of squabbling between CLGY (South San Francisco, Calif.) and FDA over how the company should design and interpret its trials.

About 765,000 Americans suffer from anal fissures, tears in the epithelial layer lining the anal canal. In the most severe cases, the condition feels like "defecating glass" and the pain is completely debilitating, Jonathan Lund, a clinician at the University of Nottingham in the U.K., told the advisory committee.

Although it is not approved, nitroglycerin ointment is widely used in the U.S. to treat anal fissures. Pharmacists compounded about 84,000 batches from October 2003 to September 2004, according to CLGY. A survey conducted by the company found that 46% of nitroglycerin ointment samples obtained from 24 retail pharmacies did not meet U.S. Pharmacopeia criteria for potency and/or content uniformity.

CLGY started out to prove that Cellegesic promotes the healing of anal fissures. Its Phase III trial failed to demonstrate an effect on healing, but using a post hoc statistical analysis, the company found a significant improvement in pain compared to placebo.

The company conducted...

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