Published: June 17, 2008
LibiGel Phase III Clinical Development Plan to be Presented at BIO International Meeting
Newswise - Female sexual dysfunction (FSD) can arise from many causes, including relationship problems, the use of prescription pharmaceuticals, disease, or chemical imbalances. Hypoactive Sexual Desire Disorder (HSDD), the biggest component of FSD, has been treated successfully and safely with testosterone for many years, albeit to date not approved for that use.
LibiGel® is a 1% testosterone gel that women apply, once a day, on their upper arm. The pea-sized volume of gel is rapidly absorbed by the skin, from where it delivers a steady dose of testosterone to the blood over 24 hours. In a Phase II clinical trial, LibiGel® increased the number of satisfying sexual events by 238%.
Although testosterone is thought of as a male hormone, it also is found in women at levels that vary with age. Researchers believe that testosterone levels, which fall with increasing age, may control a woman's sexual desire. For example, a woman in her 40's has about half the level of blood testosterone than a woman in her 20's.
The incidence of HSDD also increases with age and after certain surgical procedures. Approximately 14% of premenopausal women between the ages of 20 and 49 reported symptoms of HSDD, compared with 26% of women who had had their ovaries surgically removed. Similarly, the incidence of HSDD rises to 9% for "naturally" menopausal women. LibiGel® is designed to restore testosterone levels in post-menopausal women to levels that are considered normal to maintain a healthy libido.
Stephen M. Simes, president and CEO of BioSante Pharmaceuticals (NASDAQ:BPAX), will make two presentations at the Biotechnology Industry Organization (BIO) International Meeting and Exhibition, at the San Diego Convention Center in San Diego, California.
On Tuesday, June 17, 2008 at 3:45 PM PDT, Mr. Simes will discuss the LibiGel clinical development plan and recent market research results on the size of the potential market for LibiGel in treating female sexual dysfunction.
On June 18, 2008 from 10-11 AM PDT, Mr. Simes will present the poster he co-authored titled: "LibiGel® Treatment of Women with Hypoactive Sexual Desire Disorder (HSDD): A Clear Path to Approval." Mr. Simes will describe the protocols for three ongoing Phase III clinical trials of LibiGel. Two of the trials will include 500 women each - 250 in the placebo group and an equal number in the LibiGel® group. Study subjects will range from 30 to 65 years of age, will have undergone a hysterectomy and surgical removal of their ovaries before natural menopause, and currently will be on estrogen therapy. The primary endpoints of the trials will be the change in satisfying sexual events and sexual desire. These two trials are being conducted under a "Special Protocol Assessment (SPA)," an agreement between BioSante and FDA that the trials as designed will support the eventual approval of LibiGel.
The third study BioSante is conducting is a cardiovascular safety study, in post-menopausal women with HSDD, at the request of the FDA. The FDA's request is in line with the call for more safety data from the Endocrine Society, a medical specialty society that focuses on endocrine and metabolic diseases.
For the Phase III safety study, BioSante expects to enroll and test approximately three thousand post-menopausal women between the ages of 50 and 80 years and who have at least one cardiovascular risk factor. The primary safety outcome for this trial is the effect of treatment on the incidence of cardiovascular events, including cardiovascular-related death, heart attack, and stroke. The incidence of invasive breast cancer is a co-primary safety endpoint, and investigators also will look for benign breast masses and non-invasive breast cancers. Patients will be assessed for hirsutism, acne, and voice or skin reactions, as well as blood testosterone levels during each study visit.
HSDD is characterized by low libido and a general lack of interest in sex. If safety and efficacy endpoints are met and the FDA approves the drug, LibiGel® will become the first FDA-approved treatment specifically indicated for HSDD in menopausal women. BioSante plans on submitting a New Drug Application (NDA) in 2010 and anticipates FDA approval some time during 2010 or 2011.
Source: BioSante Pharmaceuticals
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