For your information.
New Gel Shown Effective For Treatment Of Impotence
LEXINGTON, Mass. -- June 25, 1997 - The results of a new study show SEPA/alprostadil topical gel is effective for the treatment of erectile dysfunction.
Kevin McVary, M.D., Professor of Urology, Northwestern University, Chicago, IL, conducted the in-clinic evaluation of the efficacy of a topical gel formulation of SEPA and alprostadil.
The study was a placebo-controlled, escalating dose-response design, comparing three dose levels of the gel (0.5-2.5 mg) to placebo in 48 men with clinically confirmed erectile dysfunction. Each patient received a single application of gel, and erectile responses were measured over a one and one-half hour period following dosing. Erectile scores were determined by the clinical investigator.
Mean maximum erectile responses in the drug treated groups were statistically greater than placebo. Of patients treated with topical SEPA/alprostadil, 67-75 percent responded with erections sufficient for vaginal intercourse, while 17 percent of the placebo treated group had a similar response. Treatment-induced responses began approximately 15-20 minutes after dosing, with maximal response at about 45-50 minutes.
No serious adverse events were reported in the study. Mean side effects reported by patients were mild to moderate, not related to the degree of erectile response and were not statistically different between placebo and SEPA/alprostadil treated patients. There were no differences between groups in mean age of patients, and erectile responses were not related to age.
MacroChem develops, licenses and markets products and technology for the transdermal delivery of agents for pharmaceutical and cosmetic applications. The company's patented technology, SEPA, an absorption enhancer for transdermal delivery, can effectively increase the passage of therapeutic agents through the skin, offering significant advantages over other methods of delivery. |
