Boehringer Ingelheim Pharmaceuticals released data Monday from clinical trials of its Hypoactive Sexual Desire Disorder (HSDD) drug, filbanserin. HSDD is an under-diagnosed form of female sexual dysfunction marked by a persistent or recurring lack of sexual fantasy or desire for any form of sexual activity.
The trial findings, presented at the 12th Congress of the European Society for Sexual Medicine in Lyon, France, demonstrate the drug is effective in increasing sexual desire in females while decreasing distress associated with sexual activity. In the North American Phase III trial, pre-menopausal women taking 100mg of filbanserin enjoyed an increased frequency of sexually satisfying events coupled with improved sexual functioning, and less distress from sexual dysfunction and low sexual desire. Adverse events included somnolence, anxiety, and fatigue.
Comparisons have been made between filbanserin and Pfizer’s Viagra, the first male sexual dysfunction drug that launched to extraordinary profitability in 1998, and have caused some to refer to the drug as the ‘female Viagra’.
"HSDD is a complex condition that can cause distress, and negatively impact a woman's self-esteem," said Anita Clayton, one of the lead study authors, in the study’s press release. "With this data, we are making exciting progress in women's sexual health research, as flibanserin is the first in a class of drugs being studied for this condition in pre-menopausal women. This is an important milestone for an under-recognized condition for which there is no FDA-approved treatment."
Filbanserin was originally developed and tested with the goal of treating depression. But when the drug proved ineffective during clinical trials, researchers uncovered another unprecedented effect.
“Lo and behold, a signal suggested that women receiving therapy actually had an increase in feelings of sexual desire, and we then embarked on a bold trial program that culminates here,” said Peter Piliero executive director and medical leader of Medical Affairs at Boehringer Ingelheim.
Piliero refused to speculate on potential marketing difficulties facing the drug. “I think an important takeaway is that HSDD is a medical condition that’s been around for 30 years. It’s very well-defined, but I think maybe poorly recognized and poorly understood by both patients and physicians,” said Piliero.
Boeringer Ingelheim hopes the drug will be effective in treating other groups of women as well. “Just recently we have initiated studies to investigate filbanserin as a possible treatment option for what we call naturally occurring post-menopasual women with HSDD,” said Piliero.