LibiGel®
LibiGel® is a gel formulation of testosterone, designed to be quickly absorbed through the skin after a once-daily application on the upper arm, delivering 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 (i.e. patches).
The concept behind the LibiGel® development program is intriguing – to develop a product to treat women who suffer from female sexual dysfunction for which there is no clinically tested, FDA approved product, and do this with a drug that will be shown to be safe and effective, and affordable, both to develop and for women to use. The LibiGel development program has been designed to show that LibiGel can safely improve women's sexual desire and the frequency of satisfying sexual events and decrease personal distress associated with low sexual desire in women with hypoactive sexual desire disorder (HSDD). LibiGel could be the first FDA approved product to treat FSD, specifically HSDD in menopausal women.
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 to increasing sexual desire and activity and decreasing sexual distress, studies have shown that testosterone therapy can increase bone density, raise energy levels and improve mood. The goal of testosterone treatment of women complaining of HSDD is to increase the serum testosterone towards the normal range of premenopausal women in an effort to alleviate the symptoms of this disorder.
Development / Regulatory Status
Results of Phase II
Treatment with LibiGel in BioSante's 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% versus baseline (p<0.0001);>
Progress and Plans in Phase III
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. This action confirms FDA's position that FSD and HSDD are true conditions that women experience with measurable endpoints that can be evaluated and which deserve therapeutic options. The SPA process and agreement affirms that the FDA agrees that the LibiGel Phase III safety and efficacy 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. Both Phase III safety and efficacy trials are underway and are double-blind, placebo-controlled trials that will enroll approximately 500 surgically menopausal women each for six-months of treatment.
The last issue beyond efficacy has been the question of safety of testosterone therapy in women, even though there are no data to indicate that low dose testosterone causes any serious adverse events in women. BioSante agrees with the FDA's efforts to ensure the safety of drugs in development and on the market, and has worked with the FDA to develop a program for LibiGel that is scientifically sound, affordable and realistic. BioSante is in agreement with the FDA for a clearly defined LibiGel development path that can lead to the approval of LibiGel for the treatment of FSD. Therefore, in addition to the two Phase III safety and efficacy trials described above, BioSante is conducting one Phase III cardiovascular safety study of LibiGel, which also is underway. 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 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. 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 is also being tracked throughout the study.
Clearly, it will be the safety trial that drives the NDA timeline. BioSante believes it will take approximately 12 months to enroll the women in this multi-national cardiovascular-events-driven safety trial. Therefore, BioSante expects to be able to submit the LibiGel NDA for a potential approval and launch in 2011.
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