Boehringer Ingelheim has posted new late-stage data from their clinical trials into their libido-boosting drug Flibanserin, which they are currently waiting for the European Medicines Agency and the Food and Drugs Agency to approve.
The findings from the Phase III trials were presented at the annual meeting of the American College of Obtetricians and Gynaecologists showed that a high proportion of the women taking Flibanserin at the 100 mg dose reported that, compared with the placebo, there was a significant improvement in their condition.
The study involved 1,378 women who are pre-menopausal who used a 7-point scale to assess the severity of their Hypoactive Sexual Desire Disorder (HSDD) and whether the medication made a difference to their libido.
After 24 weeks, 48.3% of the women said that they felt their condition was very much improved, compared with 30.3% taking the placebo. This counts as a statistically significant difference, which the FDA and other regulators consider alongside other matters when deciding whether or not to approve a new medication.
The panel from the FDA is set to vote in mid-June as to whether or not to grant approval. If they do, Flibanserin will become the first oral medication to be approved for the treatment of HSDD in pre-menopausal women. We do not yet have a target date for the European Medicines Agency.
Currently there is some confusion about low libido with women, with some doctors arguing that the medicalisation of the condition will lead to psychological reasons for sexual problems being overlooked. However, others think that the drug is a huge step forward and will encourage doctors and patients to discuss the problem more openly.