Flibanserin pills to arouse sexual desire in females by Boehringer Ingelheim is coming

Unlike Viagra, flibanserin works on the brain to rekindle sexual appetite in women

Flibanserin, a pill arouse sexual desire in women by Boehringer Ingelheim GmbH, is currently underway.

Flibanserin, whose phase 3 data will be presented this week at a meeting on sexual disorders in Lyon, is being watched as female Viagra with the potential to revolutionize the treatment of the rather complex medical condition of decreased sexual libido in women.

Flibanserin, however, addresses sexual desire problem in women by working in the libido boosting mechanics of the brain, unlike Viagra which helps driving more bloodlow to men’s penile area leading to erection.

Flibanserin is non-hormonal oral daily treatment for pre-menopausal women suffering from Hypoactive Sexual Desire Disorder (HSDD).

Flibanserin works on the central nervous system and acts as a 5-HT1A serotonin receptor agonist and 5-HT2A serotonin receptor antagonist.

Boehringer Ingelheim is investigating flibanserin as a potential treatment for women with Hypoactive Sexual Desire Disorder (HSDD), a condition characterized as suffering from decreased sexual desire.

Boehringer Ingelheim is currently conducting several large Phase III clinical trials evaluating flibanserin in over 5,000 women at 360 locations in the USA, Canada and Europe.

The trials – The Bouquet Studies – are expected to be completed in 2008/09. They will provide a greater understanding of flibanserin’s potential to treat HSDD in pre-menopausal women.

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.

Endpoints for flibanserin trials are based on guidance received from US FDA and include measuring increases in the level of sexual desire, decreases in distress related to low desire, as well as the number of `satisfying sexual events`.

Up to one in ten women are suffering from a condition called hypoactive sexual desire disorder (HSDD) with only a third of these seeking advice or help from their healthcare professional, data from American College of Obstetricians and Gynaecologists (ACOG) annual clinical meeting suggest.

HSDD is a highly prevalent, yet under-diagnosed, medical condition that can have a serious, detrimental effect on women’s quality of life, causing significant psychological distress and negatively impacting their relationships with their partners.

HSDD is a type of female sexual dysfunction, defined in the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) of the American Psychiatric Association, as diminished feelings of sexual interest or desire, absent sexual thoughts or fantasies and lack of responsive desire that causes marked distress or interpersonal difficulties and is not caused by a medical condition or drug.

Neurotransmitters in the brain and sex hormones both play a role in normal sexual function. The brain is central to sexual response and while hormonal treatments may be of benefit to some women who suffer from HSDD, for example those women who have had a surgical menopause through ovarectomy (removal of the ovaries), this is by no means the complete answer for the many millions of women experiencing HSDD.

“Flibanserin is currently being researched for its potential to help the many women suffering from HSDD. In my everyday practice I have seen many women with this condition for whom this may mean hope as they search for help”, said lead study investigator Dr Evan Goldfischer.

If approved, flibanserin could become one of those very few drugs currently available to treat declining sexual libido in women in the US market.

The market for medicines to rekindle female libido could be bigger than the $2 billion a year in U.S. sales.

The only female sexual dysfunction therapy approved in the U.S. is Eros-CTD, from NuGyn, Inc., a suction pump that fits over the clitoris.

Intrinsa, a testosterone patch from Noven Pharmaceuticals Inc. licensed by Procter & Gamble, is sold in Europe for women whose uteruses have been removed.

Intrinsa approval is put on hold in US in 2004 on concerns of safety.

Procter & Gamble’s patch,  LibiGel, a testosterone gel from BioSante and bremelanotide, an injected therapy from Palatin Technologies are othe other potential therapies for dicreased female libido currenly under development.

Headquartered in Ingelheim, Germany, Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies.