Healthcare Industry News: estradiol gel
News Release - March 19, 2008
BioSante Pharmaceuticals Initiates Third LibiGel(R) Phase III Trial in the Treatment of Female Sexual Dysfunction under an SPALINCOLNSHIRE, Ill.--(HSMN NewsFeed)--BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX ) announced today that it has initiated a new Phase III safety and efficacy trial of LibiGel® (transdermal testosterone gel) in the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD). This is the second of two safety and efficacy trials to be conducted under conditions set forth in a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). The double-blind, placebo-controlled Phase III trial will enroll approximately 500 surgically menopausal women for a six-month clinical trial. BioSante also is enrolling women in an ongoing Phase III safety study of LibiGel, and another Phase III safety and efficacy trial under the same SPA.
The SPA 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.
“The LibiGel Phase III clinical program now is fully underway. As of today, we have initiated two LibiGel Phase III safety and efficacy trials and one Phase III cardiovascular safety study,” said Stephen M. Simes, BioSante’s president & CEO. “We are implementing the clearly defined, reasonable, feasible and affordable development path as outlined in our agreement with the FDA that may 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 the treatment of FSD in menopausal women in the U.S.”
“In addition to being a major milestone for LibiGel and BioSante, the SPA is a significant development for the entire FSD category,” Simes added. “The SPA with the FDA confirms FDA’s position that FSD is a true diagnosable condition that women experience; that there are clinical endpoints that can be studied, measured and evaluated; and that FSD is a condition which deserves therapeutic options for treatment.”
The primary endpoints in the two LibiGel safety and efficacy clinical trials are an increase in the number of satisfying sexual events and sexual desire with a secondary endpoint of a decrease in sexual distress. These SPA trials use BioSante’s validated instruments to measure these clinical endpoints.
In addition to the two LibiGel Phase III safety and efficacy trials, BioSante is enrolling women in 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.
LibiGel is a gel formulation of testosterone designed to be quickly absorbed through the skin after application of a pea-sized dose of gel 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 products primarily for transdermal administration of estradiol and testosterone. 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, marketed in the U.S. by Nycomed US, 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.
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The statements regarding BioSante contained in this news release that are not historical in nature, particularly those that utilize terminology such as “will,” ”potential”, “could,” “can,” ”intends,” “continue,” “plans,” “expects” or comparable terminology, are forward-looking statements. Examples of forward-looking statements in this news release include statements regarding the expected timing of the initiation of clinical trials and the submission of regulatory applications. Forward-looking statements are based on current expectations and assumptions, and entail various risks and uncertainties that could cause actual results to differ materially from those expressed in such forward-looking statements. Important factors known to BioSante that could cause actual results to differ materially from those expressed in such forward-looking statements include the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance, the success of clinical testing, and other factors identified and discussed from time to time in BioSante's filings with the Securities and Exchange Commission, including those factors discussed in BioSante's most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q, which discussions also are incorporated herein by reference. All forward-looking statements speak only as of the date of this news release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Source: BioSante Pharmaceuticals
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