Pre-menopausal women with HSDD report clinically meaningful improvement with flibanserin

Boehringer IngelheimMay 19 2010

Significantly more pre-menopausal women with hypoactive sexual desire disorder (HSDD) reported a clinically meaningful improvement in their condition with flibanserin 100mg compared with placebo, according to new research announced today. Flibanserin is an investigational, non-hormonal treatment being developed by Boehringer Ingelheim for pre-menopausal women with HSDD.

“Do you believe you experienced a meaningful benefit from the study medication?”

More than 1,300 women were included in the pre-specified, pooled Phase III study analysis, presented at The American Congress of Obstetricians and Gynaecologists (ACOG) annual clinical meeting. All of the women had HSDD - a medical condition characterised by a decrease in sexual desire associated with marked distress and/or interpersonal difficulties.

"We know that flibanserin is effective and well tolerated in a clinical setting, but it's important to understand too whether patients themselves see a benefit from treatment," said John Thorp, study investigator and Professor of Obstetrics and Gynaecology at the University of North Carolina Medical School. "These study results are very encouraging - not only did women report an improvement in their HSDD symptoms, but they felt the improvement was meaningful to them and their overall well-being."

The patients' perspective analysis builds on existing Phase III clinical trial data which demonstrate that flibanserin 100mg taken once daily at bedtime significantly increased sexual desire while significantly decreasing the distress associated with HSDD. This was reflected in a significant increase in the number of Satisfying Sexual Events (SSEs).

Significantly more women reported clinically meaningful improvements with flibanserin

Study participants evaluated their treatment based on two measures - overall improvement in their condition, and the question "Do you believe you experienced a meaningful benefit from the study medication?"

Of 1,338 participants questioned>

• over 50% more women reported feeling 'very much improved', 'much improved' or 'minimally improved' with flibanserin compared with placebo (318 vs. 206, p<0.0001)

Of 1,219 participants questioned>

• over 50% more women reported a meaningful benefit from treatment with flibanserin compared with placebo (240 vs. 158, p<0.0001).

Flibanserin was shown to increase sexual desire and reduce associated distress

A second pre-specified analysis of the Phase III study data presented at the meeting looked specifically at women who completed treatment to trial end.

Those who received flibanserin 100mg vs. placebo experienced statistically significantly:^*

• increased sexual desire, based on improvements in:
• e-diary sexual desire score (9.7 vs. 6.9, p<0.01)
• FSFI desire domain score (0.9 vs. 0.5, p<0.0001)
• reduced associated distress, based on improvements in:
• FSDS-R Item 13 score (-0.8 vs. -0.5, p<0.0001)
• FSDS-R total score (-9.3 vs. -5.0, p<0.0001)
• more satisfying sexual events (2.1 vs. 0.9, p<0.0001)
• improved overall sexual functioning, based on improvements in:
• FSFI total score (5.3 vs. 2.6, p<0.0001)

"Although HSDD affects thousands of women, it is often misunderstood or overlooked," said Paula Hall, a sexual and relationship psychotherapist from the UK. "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."