BioSante Pharmaceuticals Inc announced that data from its placebo-controlled phase II study showed treatment with LibiGel, an investigational transdermal testosterone gel, significantly increased satisfying sexual activity in surgically menopausal women suffering from female sexual dysfunction (FSD).
The release says, study results showed an effective dose of LibiGel that significantly increased the number of satisfying sexual events by 238 per cent versus baseline (p<0.0001); this increase also was significant versus placebo (p<0.05). The effective dose of 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. No serious adverse events and no discontinuations due to adverse events occurred in any subject receiving LibiGel, indicating the safety and acceptability of LibiGel. The study was a double-blind, placebo-controlled study, conducted in the United States, that included 46 surgically menopausal women distressed by their low sexual desire and activity.
"The LibiGel data are very positive and point to the development of a safe and effective treatment for women with the low sexual desire component of FSD, also known as Hypoactive Sexual Desire Disorder (HSDD)," Dr. Leah M Lehman, vice president of clinical and regulatory affairs for BioSante said adding, "The study results indicate LibiGel is more effective than other testosterone products being developed, which may be a function of our formulation and dosing regimen."
"The LibiGel data are very exciting for physicians who treat menopausal women. We know there is a tremendous medical need to address women suffering with low sexual desire," said James A Simon, lead study investigator, clinical professor of Obstetrics and Gynecology at the George Washington University in Washington, DC and president of the North American Menopause Society. "Currently, there are no medications approved by the US Food and Drug Administration for the treatment of low sexual desire, so we're encouraged by such clinically significant improvements in sexual activity, resulting from treatment with LibiGel. We are hopeful that treatments like LibiGel will help women with low sexual desire regain a satisfying sex life," he added.
"Female sexual dysfunction is underserved by the pharmaceutical industry today. We are very pleased LibiGel may help successfully address this unmet medical need. Planning for phase III development of LibiGel is in progress, and we plan to initiate phase III trials early in 2005," said Stephen M Simes, president and chief executive officer of BioSante.
LibiGel is a gel formulation of bioidentical testosterone designed to be quickly absorbed through the skin after application on the arms, shoulders or abdomen, delivering testosterone to the bloodstream evenly over time and in a non-invasive and painless manner. Though generally characterized as a male hormone, testosterone also is present in women and its deficiency has been found to decrease libido or sex drive. Studies have further shown that testosterone therapy can increase bone density, raise energy levels and improve mood, in addition to boosting sexual desire and activity, the release added.
Study results will be presented by BioSante in an oral Podium Session on October 30, 2004 at the Annual Meeting of the International Society for the Study of Sexual Health in Women (ISSWSH) in Atlanta.
In addition to LibiGel, BioSante is developing Bio-T-Gel for treatment of men with testosterone deficiency and Bio-E-Gel for treatment of women with estrogen deficiency. The transdermal gel formulations used in the female gel products are licensed by BioSante from Antares Pharma Inc. The estrogen and testosterone markets in the United States alone account for approximately $2.5 billion in annual sales.