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Trials show effectiveness for HSDD

Data from pivotal phase III trials show that Boehringer Ingelheim's investigational treatment for hypoactive sexual desire disorder is effective

Boehringer Ingelheim has revealed that data from pooled pivotal phase III clinical trials demonstrate that flibanserin, an investigational compound for the treatment of hypoactive sexual desire disorder (HSDD) in women, has significant benefits.

HSDD is a medical condition characterised by a decrease in sexual desire associated with marked distress and/or interpersonal difficulties.

Flibanserin 100mg taken once daily at bedtime significantly increased the number of satisfying sexual events (SSEs) and sexual desire while reducing the distress associated with HSDD, according to data.

The pivotal trial programme was presented at the 12th Congress of the European Society for Sexual Medicine in France and included an analysis of three pivotal phase III North American trials – DAISY, VIOLET and DAHLIA – and the pivotal phase III European data – ORCHID.

Both the North American and European trials were designed to study flibanserin for 24 weeks in a randomised, placebo-controlled setting and involved women with generalised HSDD who were treated with flibanserin 100mg or placebo. All the women in the studies were in stable, communicative, monogamous, heterosexual relationships for at least one year and were required to use a reliable form of contraception.

“Despite studies demonstrating that HSDD is a common form of female sexual dysfunction, there is no approved prescription treatment for pre-menopausal women suffering from the condition,” said Professor Rossella Nappi, director of the gynaecology, endocrinology and menopause unit at the Maugeri Foundation, University of Pavia, Italy and primary investigator of the European pivotal trial.

“Flibanserin is a novel, non-hormonal compound, that has been investigated as a treatment for pre-menopausal women with HSDD. Based on the clinical trial results presented at ESSM, it has the potential to help many women suffering from their lack of sexual desire,” she added.

In the North American pivotal trials, the co-primary endpoints were changes from a four-week baseline period to week 21 to 24 in the number of SSEs and sexual desire score as recorded daily by patients using an electronic diary. In the European pivotal trial the primary endpoint was changed from baseline compared to week 24 in the number of SSEs, which were also recorded daily electronically.





17th November 2009


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