Cellegy Pharmaceuticals, Inc., has initiated a second Phase III clinical trial to provide confirmatory evidence that Anogesic (nitroglycerin ointment) reduces the average daily pain associated with anal fissures.
Initiation of this trial follows review by the US FDA of the study protocol and the results of a recently completed Phase III trial.
In the recently completed 304-patient clinical trial, the rate of decrease in average pain in the most effective, higher-dose of Anogesic was significantly greater than placebo (p value less than 0.0002). In this confirmatory Phase III trial, 165 patients will be treated for a period of eight weeks.
The primary endpoint of the trial is pain reduction; the secondary endpoint is complete healing of the fissure.
“Pain is the complaint that most often causes anal fissure patients to request a surgical procedure called a sphincterotomy,” said David Beck, M.D., a prominent colorectal surgeon at the Ochsner Clinic in New Orleans and an investigator in both Phase III studies.
“Nitroglycerin has shown effectiveness in controlling fissure pain and is acknowledged to be potentially effective in the healing of fissures. Anogesic, if approved, should become an important first-line treatment for this debilitating condition.”
In addition to the Anogesic anal fissures trial, Cellegy is conducting two clinical trials using Anogesic to treat haemorrhoids, a related condition that afflicts over 9 million people in the U.S. alone.
Cellegy is also developing other prescription products, including two unique transdermal testosterone gels.
The first product, Tostrex, is for the treatment of male hypogonadism, a condition that can result in decreased energy and libido in men, generally over the age of 40. Tostrex will enter Phase III clinical testing during this quarter.
The second product, Tostrelle, for the treatment of decreased sexual energy in postmenopausal women, is undergoing a Phase I/II dose ranging study.
Cellegy has also developed a line of high performance cosmeceutical products, which have been shown in clinical tests to produce significant improvements in the appearance of photodamaged and wrinkled skin.