By Kim Coghill

Washington Editor

Cellegy Pharmaceuticals Inc. has filed a new drug application asking the FDA to begin reviewing existing data on Anogesic (nitroglycerin ointment) for the treatment of pain associated with chronic anal fissures.

Richard Juelis, chief financial officer of South San Francisco-based Cellegy, said the company has just completed enrollment for the 200-patient Phase III trial and anticipates results around the end of the third quarter. Data will be submitted in a supplemental application toward the end of the year.

The company chose to submit existing data in hopes that the FDA will get a head start on the review process. Juelis said that although it is not likely that Anogesic will receive accelerated approval, the company hopes the FDA will begin looking at the application by the end of the year.

Anogesic is not an unfamiliar product to the FDA. In 1999, Anogesic failed to meet its primary endpoint of complete healing of anal fissures in a Phase III study in 304 patients. However, the data showed positive results in reducing pain, the secondary endpoint. (See BioWorld Today, Dec. 17, 1999.)

¿Unfortunately in that trial, pain was the secondary endpoint and the FDA won¿t accept your results from the secondary endpoint,¿ Juelis said. ¿They told us pain is fine, but you are going to have to do a second confirmatory trial with pain as your primary endpoint for approvability. So we¿ve basically flipped the endpoints.¿

The eight-week Phase III trial scheduled to end in September is a double-blind, placebo-controlled study requiring patients to use the product each day. Participants will complete a daily self-assessment of their pain using techniques approved by the company.

Other than the Anogesic trial, Cellegy is conducting a Phase III clinical trial of Tostrex, a testosterone gel for the treatment of male hypogonadism. The trial is expected to be complete by the end of the first quarter 2002.

Cellegy is conducting a Phase II trial using Anogesic to treat hemorrhoids, and is expanding a Phase I/II dose-ranging trial for Tostrelle, a testosterone gel for the treatment of sexual dysfunction in women.

Cellegy recently raised about $15.4 million through a private placement of 2.7 million shares. (See BioWorld Today, June 11, 2001.)

Cellegy¿s stock (NASDAQ:CLGY) closed Tuesday at $7.40, up 59 cents.