LibiGel: Topical Testosterone Gel
• Sexual Health
This press release will likely appear in many newspapers as breaking news from the frontiers of research into women's sexual wellbeing. But press releases aren't the same thing as a peer-reviewed article in The New England Journal of Medicine.
A sample of 46 while typical of much sponsored research isn't much of a sample. More to the point what may help women who've had menopausal conditions induced by surgery probably won't do women who are biologically intact a bit of good.
I fear many women suffering from sexual dysfunction will get their hopes up and not understand the specific limitations of the new product.
LibiGel(TM) utilizes Antares Pharma's propriety advanced transdermal delivery (ATD(TM)) gel technology designed to allow delivery of hormones and other products across the skin. The LibiGel(TM) study was a double-blind placebo controlled study in 46 surgically menopausal women. The effective dose of LibiGel(TM) produced testosterone blood levels within the normal physiological range for pre-menopausal women and the safety profile was similar to that of the placebo product.
By incorporating Antares Pharma's ATD(TM) gel technology, LibiGel(TM) is quickly absorbed through the skin after application on the arms, shoulders or abdomen, evenly delivering testosterone to the bloodstream in a non-invasive and painless manner. Although generally characterized as a male hormone, testosterone is also present in women, and its deficiency has been found to decrease libido (sex drive). Additional information on the study will be presented at the October 30, 2004 Annual Meeting of Sexual Health in Women in Atlanta. Phase III studies are expected to start in early 2005.
Antares Pharma will receive milestone payments at certain stages of development and royalties from end sales of LibiGel(TM) in North America. Additionally, Antares Pharma has rights to the clinical data generated for further licensing of testosterone for the treatment of FSD in other territories, including Europe and Japan.