BioSante Pharmaceuticals today announced the presentation of new Phase II clinical data on LibiGel™ (transdermal testosterone gel) at the International Society for the Study of Women's Sexual Health (ISSWSH) Annual Meeting in Atlanta.
Results show the ability of LibiGel to significantly increase the number of satisfying sexual events experienced by surgically menopausal women with female sexual dysfunction (FSD).
BioSante's Phase II study assessed the safety and efficacy of LibiGel in the treatment of surgically menopausal women with FSD. Results showed that LibiGel 150 mcg per day significantly increased the number of satisfying sexual events by 238 percent versus baseline (from 2.1 events per month at baseline to 7.1 events during month three; p<0.0001); this increase also was significant versus placebo (a LibiGel increase of 5.0 sexual events versus a placebo increase of 1.6 events; p<0.05). LibiGel produced testosterone blood levels within the normal range for pre-menopausal women and had a safety profile similar to that observed in the placebo group, with no serious adverse events observed. Notably, there was minimal application site irritation reported; in contrast, during previous trials with a transdermal testosterone patch delivery system, approximately 30 percent of subjects reported such reactions.
Approximately 43 percent of American women suffer from FSD, according to a study published in the Journal of the American Medical Association. Currently, there is no FDA-approved pharmaceutical treatment for this condition.
"These impressive results support the potential of LibiGel in helping to safely and effectively improve sexual activity in menopausal women," said James A. Simon, M.D., Clinical Professor of Obstetrics and Gynecology, George Washington University, Washington, D.C.; Medical Director, Women's Health Research Center, Laurel, Maryland and lead investigator of the study. "These study data show the ability of LibiGel to increase women's sexual functioning and enjoyment, and provide a valuable alternative for testosterone delivery in the treatment of female sexual dysfunction."
"We believe the efficacy of LibiGel, combined with its convenience of application and safety profile, will provide an important new treatment option for this under-served population of women," said Dr. Leah M. Lehman, vice president of clinical and regulatory affairs of BioSante. "We plan to initiate Phase III clinical development of LibiGel early in 2005."