Women with hypoactive sexual desire disorder (HSDD) report that flibanserin
increased their sexual desire and reduced associated distress

BURLINGTON, ON, May 19 /CNW/ - 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(1). Flibanserin is an investigational, non-hormonal treatment being developed by Boehringer Ingelheim for pre-menopausal women with HSDD.

More than 1,300 women were included in the pre-specified, pooled Phase III study conducted at 27 Canadian sites, with analysis, presented at The American Congress of Obstetricians and Gynecologists (ACOG) annual clinical meeting. All of the women had HSDD - a medical condition characterized by a decrease in sexual desire associated with marked distress and/or interpersonal difficulties(2).

"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 Gynecology 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(3). This was reflected in a significant increase in the number of Satisfying Sexual Events (SSEs).

"Low sexual desire can be very distressing, particularly for premenopausal women," says Dr. William A. Fisher, Distinguished University Professor, Department of Psychology and Department of Obstetrics and Gynecology at the University of Western Ontario. "HSDD can influence women's self-esteem, their relationships, and their overall sense of wellbeing. These clinical trials are significant: they show positive effects in treating this distressing condition."

Significantly more women reported clinically meaningful improvements with flibanserin(1)

Study participants in the two large North American trials 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 (flibanserin=659, placebo=679):

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

Of 1,219 participants questioned (flibanserin=593, placebo=626):

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

Flibanserin was shown to increase sexual desire and reduce associated distress(4)

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

* see notes to the editors for an explanation of study measures

Notes to Editors:

    
    About the studies
    -----------------
    

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

    
    1.  Patient perspectives on flibanserin treatment(1)

        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).
        -   evaluate whether they experienced a meaningful benefit from study
            medication at study end using the single-question Patient Benefit
            Evaluation - "Overall, do you believe that you have experienced a
            meaningful benefit from the study medication?"

    2.  Analysis of women who completed treatment to study end(4)

        The second analysis specifically evaluated those women who completed
        24 weeks' treatment (n=971, 70.5%). Co-primary endpoints
        were change from baseline to study end in the number of satisfying
        sexual events (SSE) and sexual desire score measured using a daily
        electronic diary (eDiary).

        -   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.
        -   The eDiary measures levels of desire on a daily basis, with the
            help of a proprietary electronic device. Levels of desire to
            choose from were "no" "low" "moderate" or "strong" desire.

        Secondary endpoints included change in Female Sexual Function Index
        (FSFI) desire domain, FSFI total, Female Sexual Distress Scale-
        Revised (FSDS-R) Item 13 and FSDS-R total scores.

        -   The FSFI is a 19-item questionnaire which provides an additional
            measurement of changes over a longer recall period. The tool,
            which has a specific desire domain, assesses both the intensity
            and the frequency of desire over a 4-week period.
        -   The FSDS-R is a 13-item questionnaire designed to assess and
            quantify the change in personal distress associated with female
            sexual dysfunction. Question 13 specifically assesses distress
            due to low sexual desire. The total score ranges from 0-52, with
            higher scores indicating more sexual distress.
    

The majority of these tools have been independently developed. All measures have undergone rigorous testing to ensure they are valid and reliable.

    
    About flibanserin
    -----------------
    

Boehringer Ingelheim is investigating flibanserin as a novel, non-hormonal treatment for premenopausal women with HSDD. Flibanserin 100mg, taken once daily orally has shown to be effective and well-tolerated in phase III clinical trials in these women suffering from HSDD(3).

How does flibanserin work?

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(5).

    
    About 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(2). 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.

    
    Boehringer Ingelheim
    --------------------
    

The Boehringer Ingelheim group is one of the world's 15 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 142 affiliates in 50 countries and 41,500 employees.

Founded in 1885, the family-owned company is committed to researching and developing novel products of high therapeutic value for human and veterinary medicine. In 2009, Boehringer Ingelheim posted net sales of 12.7 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development.

The Canadian headquarters of Boehringer Ingelheim was established in 1972 and the Research and Development Centre located in Laval, Québec, Canada since 1988. Boehringer Ingelheim (Canada) Ltd. is home to more than 700 employees including 160 scientists across the country.

For more information please visit www.boehringer-ingelheim.ca.

    
    References
    ----------

    1.  Jolly E, Thorp JM, Clayton AH, et al. Patients' perspective of
        efficacy of flibanserin in pre-menopausal women with HSDD. Oral
        presentation at the 58th Annual Clinical Meeting of the American
        Congress of Obstetricians and Gynaecologists (ACOG), May 2010.
    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.  Jolly E, Clayton AH, Thorp J, et al. Efficacy of flibanserin 100 mg
        qhs as a potential treatment for Hypoactive Sexual Desire Disorder in
        pre-menopausal women. Oral presentation at the European Society of
        Sexual Medicine Congress, November 2009.
    4.  Thorp JM, Clayton AH, Jolly E, et al. Efficacy of flibanserin in
        premonopausal women with HSDD who completed 24 weeks' treatment. Oral
        presentation at the 58th Annual Clinical Meeting of the American
        College of Obstetricians and Gynaecologists (ACOG), May 2010.
    5.  Allers K, Dremencov E, Ceci A, et al. Acute and repeated flibanserin
        administration in female rats modulates monoamines differentially
        across brain areas: a microdialysis study. J Sexual Med 2010:7
        (5):1757-1767.
    6.  Shifren JL, Monz, B, Russo P, et al. Sexual Problems and Distress in
        United States Women: Prevalence and Correlates. Obstet Gynecol
        2008;112(5): 968-969.
    

For further information: Naziah Lasi-Tejani, Hill & Knowlton, Inc., 160 Bloor Street East, Suite 700, Toronto, Ontario, M4W 3P7, Direct: [phone], Cell: [phone]; Derek O'Toole, Director, Corporate Communications and Corporate Affairs, Boehringer Ingelheim (Canada) Ltd., 5180 South Service Road, Burlington, Ontario, L7L 5H4, Direct: [phone]