You may remember that we have written about Libigel - a potential new treatment for hypoactive sexual desire disorder in women. Previous phase III trials for Libigel, showed that the treatment increased the number of sexual events that were considered satisfying, increased feelings of sexual desire and also lessened any stress linked to low levels of desire. However, the results of the placebo in the double blind trial also gleaned positive results that were higher than expected and since there was not much of a disparity between the outcomes from both the drug and the placebo, Libigel did not fair too well in terms of efficacy.
This time around, the pharmaceutical company responsible for the drug, Biosante Pharmaceuticals, is addressing this issue in the hope that they will be able to demonstrate that Libigel’s effects will far outweigh the effects of the placebo. Simultaneously, the pharmaceutical company will continue with its phase III cardiovascular and breast cancer risk trials. This study is the largest of its kind assessing the safety of the use of testosterone in women.
The efficacy trial has not yet commenced as Biosante Pharmaceuticals is currently designing the study and they will also apply for Food and Drug Administration (FDA) for a Special Protocol Assessment (SPA) before they begin. The efficacy endpoints will be the same as in the previous trial.
There is clearly an unmet demand for pharmaceutical products in this area of medicine but we are not entirely sure how Libigel will be different from Intrinsa (other than the mode of application.)