Boehringer Ingelheim announces commitment to progressing science with the Bouquet Studies

Boehringer IngelheimData announced at the American College of Obstetricians and Gynaecologists (ACOG) annual clinical meeting suggest that 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.[1] 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.[2,3]

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.[2]

According to renowned sexual health expert, Dr Sheryl Kingsberg: "While sex is an everyday topic of conversation within the media and society as a whole, women's sexual problems are rarely discussed. A decrease in sexual desire has a real and measurable distressing affect on women. The condition impacts almost every aspect of their lives and can become a constant worry". Dr Kingsberg continued: "Both patients and doctors alike can be uncomfortable discussing a woman’s sexual history but we must encourage women to seek professional advice if they feel distressed because their levels of sexual desire have decreased. We are pleased we can now support our colleagues in the diagnosis of this condition as Boehringer Ingelheim has developed a questionnaire, which allows physicians to reliably identify the many women who are suffering from this distressing condition."

Neurotransmitters in the brain and sex hormones both play a role in normal sexual function.3 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.

Boehringer Ingelheim is committed to progressing science and contributing to research in this area of unmet medical need through the Bouquet study programme, which consists of seven phase III studies. This programme investigates flibanserin*, a non-hormonal compound as a potential oral daily treatment for pre-menopausal women suffering from 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. "Boehringer Ingelheim is setting a great example with its commitment to researching new potential treatment options such as flibanserin. I am hopeful that their commitment will lead to a real breakthrough for this rarely-discussed medical condition."

The results of the Bouquet Studies will be available in late 2008/09. They will represent an important advance in the understanding of this distressing condition and may offer hope for the many millions of women and their partners affected by HSDD.

About the Bouquet Studies
The Boehringer Ingelheim 'Bouquet Study' programme is a group of phase III clinical trials investigating flibanserin* as a potential treatment for women with Hypoactive Sexual Desire Disorder (HSDD), a condition characterized as suffering from decreased sexual desire. Together, 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.

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 trials are expected to be completed in 2008/09.

Endpoints for the trials are based on guidance received from the 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'. These trials will provide a greater understanding of flibanserin's* potential as a possible oral daily treatment option for woman suffering from decreased sexual desire.

About Flibanserin*
Flibanserin* is an investigational non-hormonal compound being studied as a potential oral daily treatment for pre-menopausal women suffering from Hypoactive Sexual Desire Disorder (HSDD). The compound works on the central nervous system and acts as a 5-HT1A serotonin receptor agonist and 5-HT2A serotonin receptor antagonist. Research is ongoing to provide additional insight into flibanserin's* specific mechanism of action.

* This compound is an investigational agent. Its safety and efficacy have not yet been fully established.

About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 135 affiliates in 47 countries and 39,800 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

In 2007, Boehringer Ingelheim posted net sales of 10.9 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development.

References:
[1] Shifren J. Treatment-Seeking Behavior of U.S. Women with Hypoactive Sexual Desire Disorder (HSDD). Poster presented at The American College of Obstetricians and Gynecologists 56th Annual Clinical Meeting in New Orleans on 5 May 2008.
[2] Sexual and gender identity disorders. In: American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 4th ed. Washington, DC: American Psychiatric Association; 2000: 493-538
[3] Frank J et al. Diagnosis and Treatment of Female Sexual Dysfunction. Am Fam Physician 2008;77(5): 635-642.

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