LibiGel, a testosterone gel currently being studied to enhance sexual drive in women, is found to be improving body composition including bone mineral density in HIV infected women.
LibiGel, which is being developed by BioSante Pharmaceuticals, Inc is a low dose testosterone gel meant for the treatment for menopausal women with low sexual drive or hypoactive sexual desire disorder (HSDD).
A study using LibiGel in HIV infected women has come out with the finding that the testosterone gel is well-tolerated in HIV-infected women and resulted in significant improvement in body composition, bone mineral density (BMD), and quality of life indices.
Results of a randomized, placebo-controlled trial of testosterone in HIV-infected women are reported in a paper published in the May 15, 2009 issue of AIDS, the Journal of the International AIDS Society.
The 18-month study was conducted in 25 HIV-infected women belonging to the average age of 43-45 years old with free testosterone below the normal female range. The women were randomized to testosterone (300 micrograms per day delivered by patch) or identical placebo. The study was conducted at Massachusetts General Hospital (MGH) and Massachusetts Institute of Technology (MIT). The study was funded by the NIH (National Institutes of Health) and the Harvard Clinical Center For Research Resources.
“These newly published testosterone data are very exciting for many reasons,” said Stephen M. Simes, BioSante president and CEO.
BioSante is in late-stage development of LibiGel testosterone, at the same dosage employed in the published study, for the treatment of HSDD in menopausal women.
Mr Simes said BioSante was conducting three LibiGel Phase III clinical trials including the first large long-term cardiovascular and breast cancer safety study of testosterone in women.
The newly published data were positive for the new potential use of LibiGel in HIV-infected women. Women, whether HIV-infected or not, deserve the same options for therapy as men have had for many years, he said.
The phase III study using LibiGel is the first to investigate the effects of testosterone use over 18 months among HIV-infected women, and shows that testosterone is well tolerated over a long treatment period, according to the authors of the published paper.
The study also found testosterone had no significant effect on lipid levels, including high-density lipoprotein, and study-related adverse events were similar between the testosterone and placebo groups without significant differences in hirsutism (hair growth), hair pattern, acne or changes in menstrual pattern.
No testosterone subjects withdrew from the study due to adverse events. No serious study-related adverse events occurred during the randomized portion of the study.
Low androgen levels are common among HIV-infected women. Women with HIV are known to have reduced BMD, lean body mass, and reduced quality of life. Low androgen may contribute to such changes; yet no treatment strategies exist for women, and research investigating sex-specific treatment strategies in HIV-infected women has been limited, the authors commented.
However, treatment of hypogonadism is routine among HIV-infected men as it improves body composition, BMD, and depression.
LibiGel study data showed that testosterone treatment, at the same low daily dose being used in BioSante’s LibiGel studies, is well tolerated over 18 months and results in significant improvements in body composition, BMD and quality of life.
LibiGel: Libido booster for women
LibiGel is a gel formulation of testosterone, designed to be quickly absorbed through the skin. This once-daily application when applied on the upper arm, delivers testosterone to the bloodstream evenly over time and in a non-invasive and painless manner. The topical application of LibiGel has the added advantage of reduced skin reactions compared to other forms of transdermal delivery systems
On January 24, 2008, the US FDA notified BioSante that it had completed and reached agreement with BioSante on a Special Protocol Assessment (SPA) for BioSante’s Phase III safety and efficacy clinical trials of LibiGel in the treatment of HSDD.
Both Phase III safety and efficacy trials using LibiGel are underway and are double-blind, placebo-controlled trials that will enroll approximately 500 surgically menopausal women each for six-months of treatment.
In addition to the two Phase III safety and efficacy trials, BioSante is conducting one Phase III cardiovascular safety study of LibiGel. The safety study is a randomized, double-blind, placebo-controlled, multi-center, cardiovascular events driven study of between 2,400 and 3,100 women exposed to LibiGel or placebo for 12 months.
BioSante expects to be able to file the LibiGel NDA in 2010 for a potential approval and launch in 2011.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health, menopause, contraception and male hypogonadism. Apart from LibiGel BioSante’s lead products include Elestrin and Bio-T-Gel .
Elestrin (estradiol gel) is indicated for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, currently marketed in the U.S.
Bio-T-Gel, a testosterone gel for male hypogonadism, and an oral contraceptive in Phase II/III clinical development using BioSante patented technology.
The current market in the U.S. for estrogen and testosterone products is approximately $2.5 billion and for oral contraceptives approximately $3 billion. The company is also developing its calcium phosphate technology (CaP) for novel vaccines, drug delivery and aesthetic medicine (BioLook).