Boehringer Ingelheim has posted interesting late-stage data for its female sexual dysfunctional drug flibanserin which suggests that the treatment increases satisfaction.
Data from two Phase III trials run in North America were presented at the American College of Obstetricians and Gynaecologists annual meeting in San Francisco. They demonstrate that a higher proportion of pre-menopausal women with hypoactive sexual desire disorder receiving flibanserin 100mg “reported both an improvement in their condition and a meaningful benefit from their treatment, compared to placebo”.
The analysis included 1,378 pre-menopausal women with HSDD who were evaluated about “bothersome decreased sexual desire” using a seven-point scale from 1 (very much improved) through 4 (no change) to 7 (very much worse). After 24 weeks, 48.3% of women receiving flibanserin and 30.3% on placebo reported feeling very much improved, much improved or minimally improved . In addition, more women on the Boehringer drug reported experiencing a meaningful benefit from the study medication (40.5% versus 25.2%).
Study investigator John Thorp of the University of North Carolina Medical School said the data “offer a unique perspective on the effects of flibanserin from the patient’s point of view”. Not only did the women feel an improvement “in their symptoms of low desire and associated distress when taking flibanserin, but they also reported that this change had a meaningful benefit to them”.
These latest findings add to data from other pivotal trials which have shown that flibanserin demonstrated statistically significant improved measures of sexual desire, overall sexual functioning, distress associated with the condition and the number of satisfying sexual events, compared with placebo.
Flibanserin, an oral treatment that was originally developed as an antidepressant, affects levels of serotonin and other chemicals in the brain but how it affects sex drive remains unclear. In mid-June, an advisory panel of the US Food and Drug Administration will vote on whether to recommend approval.
Given the nature of HSDD, it is unsurprising that flibanserin is being referred to in some media circles as ‘female Viagra’. However, Paula Hall, a sexual and relationship psychotherapist from the UK, said that although HSDD affects thousands of women, “it is often misunderstood or overlooked”. She added that in both of these study analyses, “we’re seeing very positive outcomes with flibanserin, which is really quite exciting and could hold hope for those suffering with this distressing condition.”
