Cellegy Pharmaceuticals Inc announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has approved Cellegesic (nitroglycerin ointment) (Rectogesic-outside the US) in the United Kingdom for the treatment of pain associated with chronic anal fissures.

The MHRA has also agreed to act as a Reference Member State for regulatory filings of the product in other European Community Member States, a process that generally takes about six to nine months from the time formal approval is granted in the Reference Member State, an official release said.

Cellegy's regulatory filing provided data demonstrating that Rectogesic produced a statistically significant reduction in pain versus placebo when given twice daily over an eight-week treatment period (p<0.0001) and was able to achieve its effect much more quickly than the placebo (p<0.02). The most prevalent side effect was mild to moderate headache.

K Michael Forrest, Cellegy's president and CEO said, "We are delighted to achieve this important regulatory milestone in the UK, the first major country to approve the product in Europe. Cellegy is currently in licensing discussions with potential commercial partners for the product in Europe and is also seeking a partner in Japan. We expect to complete the European selection process quickly and have taken all the manufacturing steps necessary to support a product launch in the UK as early as January 2005. In addition, since the MHRA has agreed to sponsor regulatory filings in other European Member States, this product will shortly thereafter be available to fissure sufferers throughout Europe, adding to availability in Australia, New Zealand and South Korea."

Forrest continued, "In the United States, an NDA for Cellegesic has been submitted and accepted for review by the US Food and Drug Administration. The latest date for the FDA's decision on approvability is May 1, 2005. The Company plans to commercialize Cellegesic with its own sales force in the United States, assuming approval by the FDA."

An anal fissure is a painful tear in the lining of the anal canal and is associated with increased pressure in the anal canal and a decrease in blood supply. Chronic fissures often are treated with a surgical procedure that involves cutting the internal anal sphincter to decrease pressure in the anal canal.