BioSante posts additional positive LibiGel pK results

Additional results from a pharmacokinetic study by BioSante Pharmaceuticals (NASDAQ:BPAX) of its principal LibiGel testosterone gel indicate that it increases levels of free testosterone (the active testosterone component) in the serum of postmenopausal women to within the normal ranges for younger, premenopausal women.

LibiGel is in development for the treatment of female sexual dysfunction, specifically, hypoactive sexual desire disorder (HSDD) in postmenopausal women, for which there is no FDA-approved product.

The pK study was conducted in 24 surgically postmenopausal subjects in three contiguous 21 day periods for a total of 63 days, in the absence of estrogen therapy (study period 1), with a concomitant transdermal estradiol patch (study period 2) and finally with concomitant oral estrogen (study period 3). LibiGel was dosed at 0.22 gm daily, the same dose as the two LibiGel pivotal safety and efficacy trials and safety study.

The levels of free testosterone in the LibiGel pK study were similar to those seen in the BioSante LibiGel Phase 2 efficacy trial, which ranged from 2.8 pg/ml to 3.6 pg/ml. These levels also were similar to those reported in the two pivotal testosterone patch (Intrinsa) studies, which showed efficacy in treating HSDD in estrogen-treated surgically menopausal women, which were 4.0 pg/ml at 12 weeks and 3.1 pg/ml at week 24 and 4.0 pg/ml at week 24, respectively.

Free testosterone returned to baseline levels within 24 hours after the last dose of LibiGel, indicating effective elimination after dosing is discontinued. The pK study was conducted as part of the FDA-requested studies to be submitted in the LibiGel new drug application (NDA) which is anticipated in the fourth quarter of 2012.