The search for an effective treatment for low libido in women may seem a bit more complicated and confusing lately. In just one week, two independent studies focused on widely different therapeutic approaches announced completely opposite results.
One report on June 18 summarized the disappointing results of the much-heralded “pink pill” being developed by Boehringer Ingelheim of Germany. Clinical studies showed that their drug flibansersin, a type of antidepressant, failed to fully rev up chemicals in the brain known to be associated with sexual pleasure and response and didn’t help most women with low libido.
Based on the weak findings from the clinical trials that involved more than 1,500 women, an FDA advisory committee concluded that flibanserin should not be approved for treatment of hypoactive sexual desire disorder in women in the U.S.
More positive news about a new testosterone cream called LibiGel was released by the U.S. company BioSante Pharmaceuticals Inc. just a few days later. The company announced in a preliminary update from a large on-going clinical trial that LibiGel appears to be safe from serious side effects in women and has been cleared for continued clinical evaluation.
So far the data looks promising. Earlier studies indicate that LibiGel greatly increased the frequency of satisfying sexual experiences in postmenopausal women who received the treatment beyond that of similarly aged women who applied a cream with no testosterone (placebo treatment).
Currently, there is no FDA approved drug for the treatment of low sexual response in women also known as hyposexual desire disorder (HSDD). BioSante Pharmaceuticals hopes to change that.
“We believe LibiGel can be the first product to market for this unmet need,” states Michael Snabes, MD, PhD, BioSante’s vice president of clinical development in a Medical News report.
If all continues to go well in the current study, BioSante Pharmaceuticals Inc. will submit a new drug application (NDA) for LibiGel to the FDA sometime in 2011.