BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) announced today that it successfully has completed and reached agreement with the U.S. Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) process for its Phase III safety and efficacy clinical trials for LibiGel (transdermal testosterone gel) in the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD).
The SPA process and agreement affirms that the FDA agrees that the LibiGel Phase III clinical trial design, clinical endpoints, sample size, planned conduct and statistical analyses are acceptable to support regulatory approval. Further, it provides assurance that these agreed measures will serve as the basis for regulatory review and the decision by the FDA to approve a new drug application (NDA) for LibiGel.
“In addition to being a major milestone for BioSante, the SPA is a significant development for the entire FSD category,” said Stephen M. Simes, BioSante’s president & CEO. “This action by the FDA confirms FDA’s position that FSD and HSDD are true diagnosable conditions that women experience, with measurable endpoints that can be evaluated and which deserve therapeutic options.”
“With this SPA and meeting minutes received from FDA, we now have a clearly defined, reasonable, feasible and affordable LibiGel development path that can lead to the approval of LibiGel. Since no pharmaceutical product is approved for the treatment of FSD or HSDD in the U.S., LibiGel, if approved by the FDA, will address a truly unserved market. BioSante is committed to the development of LibiGel which ultimately could be the first product approved by the FDA for this treatment in the U.S.”
The SPA agreement covers the pivotal Phase III safety and efficacy trials of LibiGel in the treatment of FSD, one of which already has been initiated. The Phase III safety and efficacy trials are double-blind, placebo-controlled trials each of which will enroll approximately 500 surgically menopausal women for six-months of treatment. The primary endpoints in the LibiGel clinical trials are an increase in the number of satisfying sexual events and sexual desire and a secondary endpoint of a decrease in sexual distress. These SPA trials use BioSante’s validated instruments to measure the clinical endpoints. BioSante intends to initiate the second LibiGel Phase III safety and efficacy trial in early 2008.
In addition to the two LibiGel Phase III safety and efficacy trials, BioSante recently has initiated a 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. At the end of the 12 months, BioSante intends to submit a LibiGel NDA for review and possible approval by FDA. BioSante will continue to follow the women enrolled in the safety study for an additional four years after the NDA submission and possible approval of LibiGel.
The LibiGel safety study is tracking a composite of cardiovascular events including cardiovascular death, myocardial infarction and stroke in women with FSD who are 50 years of age or older and have at least one of a number of cardiovascular risk factors such as hypertension and diabetes. BioSante announced initiation of this Phase III safety study on January 7, 2008. The objective of the safety study is to show the relative safety of testosterone compared to placebo in the number of cardiovascular events. The incidence of breast cancer also is being tracked throughout the study.
As previously announced by BioSante, treatment with LibiGel in a Phase II clinical trial significantly increased satisfying sexual events in surgically menopausal women suffering from FSD. The Phase II trial results showed LibiGel significantly increased the number of satisfying sexual events by 238 percent versus baseline (p<0.0001); this increase also was significant versus placebo (p<0.05). In this study, 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. In addition, no serious adverse events and no discontinuations due to adverse events occurred in any subject receiving LibiGel. The Phase II clinical trial was a double-blind, placebo-controlled trial, conducted in the United States, in surgically menopausal women distressed by their low sexual desire and activity.
About LibiGel®
LibiGel is a gel formulation of testosterone designed to be quickly absorbed through the skin after application on the upper arm, 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. In addition, studies have shown that testosterone therapy can increase bone density, raise energy levels and improve mood, in addition to boosting sexual desire and activity.
According to a study published in the Journal of the American Medical Association, 43 percent of American women (about 40 million) experience some degree of impaired sexual function. Among the more than 1,400 women surveyed, 32 percent lacked interest in sex and 26 percent could not experience orgasm. According to IMS data, 1.4 million testosterone prescriptions were written off-label for women by U.S. physicians in 2006. The majority of women with FSD are postmenopausal, experiencing FSD due to hormonal changes following menopause, whether natural or surgical.
About BioSante Pharmaceuticals, Inc.
BioSante is developing a pipeline of hormone therapy products to treat both men and women. These hormone therapy products are gel formulations for transdermal administration that deliver estradiol and testosterone. BioSante's lead products include LibiGel® (transdermal testosterone gel) in Phase III clinical development by BioSante for the treatment of female sexual dysfunction (FSD) and Elestrin™ (estradiol gel) developed through U.S. Food and Drug Administration (FDA) approval by BioSante indicated for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, marketed in the U.S. by Bradley Pharmaceuticals, Inc., BioSante's licensee. 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 $3.0 billion. The company also is developing its calcium phosphate nanotechnology (CaP) for novel vaccines, drug delivery, and aesthetic medicine (BioLook™). Additional information is available online at: www.biosantepharma.com.