Newswise — This August is Menopause Awareness Month, a good time for women to discuss with their doctors female sexual dysfunction, a real but often-overlooked medical condition. It may be surprising to learn that approximately forty million American women suffer from some type of female sexual dysfunction (FSD), which can arise from many causes, including increasing age, certain surgical procedures, the use of prescription pharmaceuticals, disease, or chemical imbalances.
The most common form of FSD is Hypoactive Sexual Desire Disorder (HSDD), sometimes referred to as low sex drive. In a study published in the July 14, 2008 edition of the prestigious medical journal, Archives of Internal Medicine, researchers found that the prevalence of low sexual desire ranged from 26.7% among pre-menopausal women, to 52% among post-menopausal women. Moreover, the incidence of HSDD was as high as 12.5% in surgically menopausal women. (This group of women has had their ovaries removed.)
HSDD has been treated with testosterone for many years, although the hormone has not been specifically approved for that use to date. Although testosterone is popularly thought of as a male hormone, it also is found in women. Researchers believe, and recent clinical trials support that testosterone levels, which fall with increasing age or the removal of the ovaries, may influence a woman's sexual desire.
One treatment option in development, LibiGel® by BioSante Pharmaceuticals, Inc. (Nasdaq: BPAX) is designed to restore testosterone levels in post-menopausal women to levels that are considered normal to maintain a healthy libido. LibiGel® is applied once daily using a metered dose bottle that administers a pea-sized amount of gel to be rubbed into the upper arm, delivering the required therapy to the bloodstream evenly over twenty-four hours. The gel is quick drying, non-invasive, and painless leaving no trace of residue with virtually no site irritation.
After nearly a decade of research and development and tests involving three thousand women, Pfizer, creators of the blockbuster male erectile dysfunction drug, Viagra, discontinued its own attempt at a female sexual dysfunction drug in February 2004 following clinical trial failures. According to a February 28, 2004 article in the New York Times, while Pfizer's drug, a compound named R-13, was able to create "the outward signs of arousal in many women, that seems to have little effect on a woman's willingness, or desire, to have sex." By comparison, in a Phase II clinical trial, LibiGel® increased the number of satisfying "sexual events" by 238%.
Currently undergoing Phase III testing, LibiGel® likely will become the first FDA-approved treatment specifically indicated for HSDD in menopausal women, if safety and efficacy endpoints are met and the FDA approves the drug.
For those covering this news, BioSante Pharmaceuticals makes available Dr. Sheryl A. Kingsberg, clinical psychologist and associate professor in the Departments of Reproductive Biology and Psychiatry at Case Western Reserve University School of Medicine.
Topics for discussion include:"¢ How might physicians better initiate discussions about female sexual dysfunction with post-menopausal patients?"¢ What are some of the causes of female sexual dysfunction in post-menopausal women?"¢ What are some of the negative effects of a sudden drop in female sexual desire?"¢ How does testosterone, popularly thought of as a male hormone, influence female sexual desire?"¢ Why did Pfizer abandon its decade-long attempt at a female sexual dysfunction drug?"¢ How does BioSante's LibiGel ® address Hypoactive Sexual Desire Disorder and when might it be available to post-menopausal patients?
About Sheryl A. Kingsberg, PhDDr. Kingsberg is a clinical psychologist and associate professor in the Departments of Reproductive Biology and Psychiatry at Case Western Reserve University School of Medicine. She is also the chief of the Division of Behavioral Medicine in the Department of Obstetrics/Gynecology at MacDonald Women's Hospital.
Dr. Kingsberg has authored numerous peer-reviewed manuscripts as well as several book chapters on topics including menopause and sexuality, sexual aversion disorder, the treatment of psychogenic erectile dysfunction, oocyte donation, and infertility. She sits on the editorial boards for the journals Menopause and the International Journal of Impotence Research. Her main research interests are in sexual medicine and the psychological aspects of infertility and menopause.
Dr. Kingsberg discloses that she has received funding from BioSante, Boehringer Ingelheim, Eli Lilly, and Procter and Gamble.
About BioSante Pharmaceuticals, Inc. (Nasdaq: BPAX)BioSante is a specialty pharmaceutical company focused on developing products for female sexual health, menopause, contraception and male hypogonadism. BioSante's lead products include LibiGel® (transdermal testosterone gel) in Phase III clinical development by BioSante under a U.S. Food and Drug Administration (FDA) SPA (Special Protocol Assessment) for the treatment of female sexual dysfunction (FSD), and Elestrin™ (estradiol gel) developed through FDA approval by BioSante, indicated for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, currently marketed in the U.S. Also in development are Bio-T-Gel™, a testosterone gel for male hypogonadism, and an oral contraceptive in Phase II 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 also is developing its calcium phosphate technology (CaP) for novel vaccines, drug delivery and aesthetic medicine (BioLook™). Additional information is available online at: http://www.biosantepharma.com.
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