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. That would mean LibiGel could be on the market the following year once it meets all the safety, efficacy, and manufacturing standards set by the FDA.
The negative results from Boehringer Ingleheim’s recent flibanserin study will not affect the approval of BioSante’s LibiGel testosterone cream because the two treatments are very different medications. “The FDA Advisory Committee’s judgment on flibanserin has no impact on the clinical development program of LibiGel.” says Dr. Snabes.
In one important way the recent flibanserin report may end up having a positive influence in the area of women’s sexual health. In their summary, the FDA Advisory Committee acknowledged hyposexual desire syndrome as a significant medical issue for women and concluded that it deserves more research attention.
Additional Details about Testosterone and LibiGel:
Low levels of testosterone in various forms have been used for nearly a decade as “off label” treatments for low libido in women or what is now called hyposexual desire disorder.
Unlike flibanerin, that was tested in premenopausal women with an average age of 35 to 37 years old, testosterone has been primarily investigated as a possible treatment for low sexual desire in older naturally postmenopausal women or women who have undergone hysterectomies. Several short-term preliminary clinical trials have shown that delivery of low levels of testosterone through the skin using patches or creams improved sexual desire in postmenopausal women.
What isn’t clear is how effective and safe testosterone will be when administered to women over a long period of time. Researchers were especially interested in finding out if testosterone exposure would put women at a higher risk for heart disease or the development of cancer, particularly breast cancer.
The current clinical trials sponsored by BioSante Pharmaceuticals address this issue.
By the time the on-going LibiGel study ends in 2014, up to 4,000 postmenopausal women, some selected for the study because they have a high risk for cardiovascular problems, will use the testosterone or placebo gel every day for twelve months. They will be evaluated to see if the testosterone treatment increases the women’s reported number of satisfying sexual experiences per month compared to the gel without testosterone. The women will also be followed for up to a total of four years to determine how often heart problems or breast cancers develop.
Sources:
Biosante Pharmaceuticals Reports Positive LibiGel® Safety Data in Phase II Program,
Medical News Today, October 22, 2009.
http://www.medicalnewstoday.com/articles/168220.php
BioSante Pharmaceuticals Reports Positive LibiGel Safety Data in Phase III Clinical Program,” Drugs. Com, June 21, 2010.
http://www.drugs.com/clinical_trials/biosante-pharmaceuticals-reports-positive-libigel-safety-data-phase-iii-clinical-program-9670.html
BioSante Pharmaceuticals Says FDA Advisory Committee Recommendation Against Flibanserin has No Impact on LibiGel,” Drugs.com article, June 21, 2010.
http://www.drugs.com/nda/libigel_100621.html
Related EmpowHER Articles:
“Female Viagra Rejected by FDA Panel,” June 18, 2010.
https://www.empowher.com/female-sexual-challenges/content/female-viagra-rejected-fda-panel
“What is LibiGel?” Dr. Goldstein (VIDEO), February 24, 2010.
https://www.empowher.com/female-sexual-challenges/content/what-libigel-dr-goldstein-video
“BioSante Announces Presentation of LibiGel Safety Update at ENDO 2010,” June 18, 2010.
http://www.news-medical.net/news/20100618/BioSante-announces-presentation-of-LibiGel-safety-update-at-ENDO-2010.aspx
Contributed by: D. Jenkins, Ph.D.