Female Viagra Flibanserin works better for women with low sexual desire: Boehringer

Flibanserin, an experimental female Viagra to stimulate sexual desire, has been found effective in more women with low sexual libido in new studies by Boehringer Ingelheim.

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.

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, he added.

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.

Of 1,219 participants questioned over 50% more women reported a meaningful benefit from treatment with flibanserin compared with placebo).

Flibanserin was shown to increase sexual desire and reduce associated distress.

In both studies, data from two 24-week randomised, placebo-controlled Phase III North American trials (VIOLET and DAISY) were pooled in a pre-specified analysis.

In the first analysis, study participants were asked to evaluate the overall improvement in their condition (bothersome decreased sexual desire) using the Patient’s Global Impression of Improvement (PGI-I) measure, which is rated on a 7-point scale from 1 (very much improved) through 4 (no change) to 7 (very much worse)

The second analysis specifically evaluated those women who completed 24 weeks’ treatment. Co-primary endpoints were change from baseline to study end in the number of satisfying sexual events (SSE).

Sexually satisfying events (SSE) measures the number of sexual events (defined as sexual intercourse, oral sex, masturbation or genital stimulation by the partner), and whether the event was satisfying for the woman (i.e. gratifying, fulfilling, satisfactory and/or successful), irrespective of whether women had an orgasm or whether the event was satisfying for the partner.

Flibanserin is a 5-HT1A agonist and 5-HT2A antagonist. The term refers to the fact that flibanserin mainly targets these two types of serotonin receptors, the 5-HT1A receptor as an agonist and the 5-HT2A receptor as an antagonist.

Preclinical evidence shows that flibanserin targets these receptors preferentially in selective brain areas. An intricate interplay between stimulatory neurotransmitter systems (dopamine and norepinephrine) and inhibitory systems (serotonin, 5-HT) is part of the natural sexual response.

By modulating these neurotransmitter systems in selective brain areas, flibanserin may correct an imbalance in these systems, which leads to a healthy sexual response.

Boehringer Ingelheim’s is running  a group of phase III clinical trials called `Bouquet Study` programme.

The Bouquet Studies comprise seven trials including ROSE, DAHLIA, VIOLET, DAISY, ORCHID, SUNFLOWER and MAGNOLIA and are being conducted by Boehringer Ingelheim in North America and Europe involving over 5,000 pre-menopausal women.

The Bouquet Studies aim to demonstrate the efficacy and safety of flibanserin to support regulatory approval of flibanserin to treat this common and distressing condition.

What is hypoactive sexual desire disorder?

HSDD is a form of Female Sexual Dysfunction (FSD). As defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV), HSDD is the persistent lack (or absence) of sexual fantasies or desire for any form of sexual activity marked by distress or interpersonal difficulty and not better accounted for by another disorder (except another sexual dysfunction), direct physiological effects of a substance (including medications) or a general medical condition.

Generalised, acquired HSDD is not limited to certain types of stimulation, situations or partners, and develops only after a period of normal functioning.

Low sexual desire with associated distress is the most commonly reported female sexual complaint.

In prevalence studies 6 approximately 1 in 10 women reported low sexual desire with associated distress, which may be HSDD.

Sexual desire disorders are generally under-diagnosed and there are currently no pharmacological treatments available for pre-menopausal women with HSDD. HSDD has been recognised as a medical condition for over 30 years.

Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally with 142 affiliates in 50 countries.

In 2009, Boehringer Ingelheim posted net sales of 12.7 billion euro while spending 21% of net sales in its largest business segment Prescription Medicines on research and development.