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."
Note: BioSante will hold a conference call for investors today at 8:30 a.m. EST. To participate, dial toll-free (877) 407-9205. To access the live broadcast in listen-only mode, please visit: http://www.vcall.com/CEPage.asp ?ID=89677, which will be available until February 1, 2005.
The multicenter, randomized, double-blind, placebo-controlled study included 46 subjects. Treatment groups included 75 mcg, 150 mcg or 300 mcg of LibiGel once daily for three months, following an eight-week baseline period. Subjects in the control group received a placebo gel. At baseline, all subjects (surgically menopausal women age 39-60 distressed by low sexual desire and activity) were assessed on testosterone levels, sexual function, as well as other exploratory measures, including a global efficacy question to determine overall improvement in sexual desire. Sexual activity was recorded in a diary for the duration of the trial.
Increases from baseline in four-week sexual event rate were observed in all LibiGel dose groups during treatment. LibiGel at 150 mcg was shown to be the effective dose with an increase from baseline of five (5) satisfying sexual events at month three (the primary endpoint), compared to an increase of 1.6 for placebo; a statistical difference of 3.4 (p< 0.05). LibiGel was well tolerated during the three months of treatment, with an adverse event profile similar to placebo. No serious adverse events and no discontinuations due to adverse events occurred; notably, no hirsutism or acne was reported.