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news.Boehringer Ingelheim Pharmaceuticals has released data from pivotal Phase III clinical trials which showed that a higher proportion of pre-menopausal women with hypoactive sexual desire disorder (HSDD) receiving Flibanserin 100mg reported an improvement in their condition compared to placebo.
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The findings, presented by Boehringer Ingelheim Pharmaceuticals at the 58th Annual Clinical Meeting of the American College of Obstetricians and Gynecologists in San Francisco, include data from a pre-specified pooled analysis of two pivotal North American trials (Daisy and Violet) assessing flibanserin 100mg in pre-menopausal women suffering from HSDD.
Boehringer Ingelheim Pharmaceuticals said that these findings add to data from the primary and secondary endpoint analysis of flibanserin pivotal trials. According to the pre-specified pooled analysis of women who completed 24 weeks of treatment, Flibanserin 100mg showed improved measures of sexual desire, overall sexual functioning, distress associated with low sexual desire, and the number of satisfying sexual events (SSE), compared with placebo.
John Thorp, professor of obstetrics and gynecology at University of North Carolina Medical School and study investigator said: “These new data offer a perspective on the effects of flibanserin 100mg from the patient’s point of view.
“Not only did pre-menopausal women with HSDD report feeling 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.”
Peter Piliero, executive director of medical affairs at Boehringer Ingelheim Pharmaceuticals, said: “We are committed to advancing Flibanserin’s development to help understand and find a treatment for women affected by this distressing medical condition.”