BioSante Pharmaceuticals, Inc. (BPAX) Wednesday said LibiGel did not meet the co-primary or secondary endpoints in two pivotal Phase III efficacy trials in the treatment of hypoactive sexual desire disorder in postmenopausal women. The trials were conducted according to an FDA-agreed special protocol assessment agreement.
LibiGel is in development for the treatment of female sexual dysfunction, specifically, hypoactive sexual desire disorder or HSDD in postmenopausal women, for which there is no FDA-approved product.
The co-primary endpoints of both LibiGel efficacy trials were the change in the total number of days with a satisfying sexual event from baseline, and the change in mean sexual desire from baseline. The secondary endpoint for both trials was the change in sexual distress from baseline.
Subjects in the first trial, called BLOOM-1, who were treated with LibiGel showed an increase of 1.47 days with a satisfying sexual event compared to baseline, while those receiving placebo gel showed an increase of 1.26 days with a satisfying sexual event compared to baseline.
Subjects in BLOOM-2 who were treated with LibiGel showed an increase of 1.0 day with a satisfying sexual event compared to baseline, while those receiving placebo gel showed an increase of 1.28 days with a satisfying sexual event compared to baseline.
Although there were no statistical differences in the endpoints, BioSante said all results were in the appropriate directions. The LibiGel groups in both trials showed an increase in free testosterone levels compared to baseline and placebo.
The trials demonstrated that LibiGel was generally well tolerated with a safety profile that appeared to be comparable to placebo.
The two completed Phase III efficacy trials were randomized, double-blind, placebo-controlled trials which enrolled 597 and 575 surgically menopausal women, respectively, for six-months of therapy.
BioSante continues to conduct the Phase III LibiGel safety study, a cardiovascular events and breast cancer study that has completed enrollment of 3,656 women and has accrued over 5,100 women-years of exposure, to date. The study is designed for a total of five years; however, BioSante could use the safety study data as part of a New Drug Application (NDA) submission after the last subject enrolled has completed 12 months of exposure to LibiGel or placebo.
Stephen Simes, Lincolnshire, Illinois-based BioSante's president & CEO, said," We will continue to analyze the efficacy trial data fully and determine plans for our next steps in the LibiGel development plan, and provide an update at a later time."
BPAX closed Wednesday's regular trade at $2.12, down $0.40 or 15.87%, on the Nasdaq. In the after-hours, the stock gained $0.01 or 0.47%. Over the past year, the stock traded in a range of $1.47 - $4.02.
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