BioSante presents validation records for LibiGel

As per FDA published guidance for patient reported outcome (PRO) studies, the pivotal efficacy studies of LibiGel require the use of validated methods to measure sexual events and sexual desire, the primary patient reported endpoints. BioSante has completed validation studies of a patient diary to measure the number of satisfying sexual events and level of sexual desire.

BioSante worked with FDA’s division of reproductive and urologic products and followed the FDA’s guidance document on validation of PRO instruments in completing studies to assure the accuracy, completeness and discriminatory validity of the patient diary. The BioSante inventory of sexual events and desire (ISED) was able to differentiate between women with hypoactive sexual desire disorder (HSDD) and women without FSD in a highly statistically significant manner in the categories of sexually satisfying events and sexual desire (p less than 0.001).

The Phase III efficacy trials of LibiGel in the treatment of FSD, one of which has been initiated, are double-blind, placebo-controlled trials that will enroll up to approximately 500 surgically menopausal women each for a six-month clinical trial. The efficacy trial already initiated is being conducted under a Phase III protocol reviewed by and on file with the FDA and in which written FDA comments have been received and incorporated. BioSante hopes to initiate the second Phase III efficacy trial by early 2008.

In addition to two Phase III efficacy trials, BioSante will conduct one Phase III cardiovascular safety study. The safety study will be 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. A new drug application can be filed and reviewed by FDA, possibly leading to approval of LibiGel, at that time. After NDA submission and potential approval, BioSante will continue to follow the women enrolled in the study for an additional four years.

Stephen Simes, president and CEO of BioSante, said: “We are pleased with these results. Patient reported outcome tools are difficult to validate and these results allow us to confidently move forward with the pivotal efficacy studies for the development and potential approval of LibiGel in the treatment of female sexual dysfunction, an underserved market in the US since no pharmaceutical product is approved for its treatment. BioSante is committed to the development of LibiGel for FSD which may ultimately be the first product approved by the FDA for this treatment in the US.”