Flibanserin Demonstrates Efficacy and Tolerability in Pivotal Phase III Trials in Pre-Menopausal Women With Hypoactive Sexual Desire Disorder (HSDD)

Ingelheim, Germany, November 16 (ots/PRNewswire) -

- Results Support Flibanserin as a Potential Treatment for HSDD,
an Under-Recognised Women's Sexual Health Condition

- For Medical Media, Outside the US Only

Data from pooled, pivotal Phase III clinical trials demonstrate
that flibanserin 100mg taken once daily at bedtime significantly
increased the number of Satisfying Sexual Events (SSEs) and sexual
desire while significantly decreasing the distress associated with
Hypoactive Sexual Desire Disorder (HSDD).[1] Flibanserin is an
investigational compound that is being developed by Boehringer
Ingelheim for the treatment of pre-menopausal women with HSDD.

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HSDD is a medical condition characterised by a decrease in sexual
desire associated with marked distress and/or interpersonal
difficulties.[2] Women with HSDD often feel a loss of intimacy and
closeness that they used to enjoy. The condition can negatively
impact a woman's life and her relationship with her
partner.[2],[3],[4],[5]

The complete flibanserin pivotal trial programme was presented
today at the 12th Congress of the European Society for Sexual
Medicine in Lyon, France. It included an analysis of three pivotal
Phase III North American trials (DAISY(R), VIOLET(R) and DAHLIA(R))
and the pivotal Phase III European data (ORCHID(R)). In addition
results from a pooled analysis of two pivotal Phase III North
American trials (DAISY(R) and VIOLET(R)) and a pooled analysis of the
North American and European data (DAISY(R), VIOLET(R) and ORCHID(R))
were presented, assessing the safety and efficacy of flibanserin
100mg in pre-menopausal women suffering with HSDD.

"Despite studies demonstrating that HSDD is a common form of
female sexual dysfunction, there is currently no approved
prescription treatment for pre-menopausal women suffering from the
condition" said Professor Rossella Nappi, director of the
Gynaecological Endocrinology & 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."

Pooled North American Phase III Trial Results (DAISY(R) and
VIOLET(R))[6]

The pre-specified pooled analysis of 1,378 pre-menopausal women
with HSDD shows a statistically significant increase in the frequency
of SSEs per month in women taking flibanserin 100mg (from 2.8 at
baseline to 4.5), versus placebo (2.7 at baseline increasing to 3.7)
over the 24-week study period. Flibanserin also demonstrated
statistically significant improvements in sexual desire versus
placebo as measured by an electronic diary (the eDiary For HSDD
Trials(c)). This finding was further supported by data from the
desire domain of the Female Sexual Function Index (FSFI) as an
independent secondary measure.

Other key secondary endpoints showed flibanserin significantly
improved sexual functioning (as measured by the FSFI total score),
distress related to sexual dysfunction (as measured by the Female
Sexual Distress Scale-Revised, FSDS-R, score) and distress related to
low sexual desire (FSDS-R Item 13 score) versus placebo.

European Phase III Trial Results (ORCHID(R))[7]

The analysis of 634 pre-menopausal women with HSDD showed women
taking flibanserin 100mg had statistically significant improvements
in their level of sexual desire, as measured by the eDiary. These
findings were supported by a trend towards an increase in the FSFI
desire domain. In addition there was a statistically significant
improvement in the level of distress associated with sexual
dysfunction (as measured by the FSDS-R total score) as well as
distress related to low sexual desire (FSDS-R Item 13) which is the
second key parameter for the diagnosis of HSDD. A numerical increase
in the number of SSEs compared to placebo supports the efficacy of
flibanserin in pre-menopausal women suffering with HSDD.

North American and European Phase III Trial Results - Pooled
Analysis (DAISY(R), VIOLET(R) and ORCHID(R))[1]

A pooled analysis of pivotal data including the European study
(ORCHID(R)) and the American Phase III trials (DAISY(R) and
VIOLET(R)) reinforces the efficacy of 100mg flibanserin for the
treatment of pre-menopausal women with HSDD. Results show a
statistically significant improvement versus placebo in the number of
SSEs, as well as a statistically significant increase in the level of
sexual desire, recorded via the eDiary and the FSFI desire domain
scores. Distress associated with sexual dysfunction and specifically
low sexual desire was significantly reduced with flibanserin 100mg
(as measured by FSDS-R score and FSDS-R Item 13 score).

Safety Analysis[8]

Most adverse drug reactions with flibanserin 100mg were mild to
moderate, emerged during the first 14 days of treatment and resolved
with continued treatment. The most common adverse events (AEs)
reported by more women on flibanserin than on placebo included
dizziness, nausea, fatigue, somnolence and insomnia. The findings are
consistent across the North American and European trials with about
14% and 16% of women on flibanserin 100mg and 8% and 5% of women on
placebo discontinuing treatment due to AEs in the respective trials.

"Findings from the pivotal Phase III trials show that flibanserin
100mg is effective and well-tolerated for the treatment of Hypoactive
Sexual Desire Disorder in pre-menopausal women," said Elaine Jolly,
Medical Director, Shirley E. Greenberg Women's Health Centre of the
Ottawa Hospital and Professor of Obstetrics and Gynecology,
University of Ottawa, and one of the Canadian physicians
participating in the Phase III trials. "Flibanserin acts as an
agonist at the serotonin 5-HT1A receptor and as an antagonist at the
5-HT2A receptor with preferential affinity to selective brain areas.
It is believed to act on neurotransmitters within the brain that are
thought to play a role in sexual response. By modulating these
neurotransmitter systems, flibanserin may help to restore a balance
between inhibitory and excitatory factors leading to a healthy sexual
response."

Notes to Editors:

This release is from Boehringer Ingelheim Corporate Headquarters
in Germany. Please be aware that there may be national differences
between countries regarding specific medical information, including
licensed uses. Please take account of this when referring to the
information provided in this document. This press release is not
intended for distribution within the U.S.A.

Please be advised that further background information on the
subject of this press release can be accessed via the Boehringer
Ingelheim Corporate website following this link:

http://www.boehringer-ingelheim.com/corporate/news/press_releases
/detail.asp?ID=7095

[1] 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. Abstract accepted to the European
Society of Sexual Medicine Congress, November 2009.

[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] Dennerstein L, Koochaki P, Barton I, et al. Hypoactive Sexual
Desire Disorder in menopausal women: a survey of Western European
women. J Sex Med. 2006;3:212-222

[4] Dennerstein L, Hayes R, Sand M, et al. Attitudes toward and
frequency of partner interactions among women reporting decreased
sexual desire. J Sex Med. 2009;6:1668-1673

[5] Basson R. Women's sexual dysfunction revised and expanded
definitions. CMAJ. 2005;172:1327-1333

[6] Jolly E, Clayton AH, Thorp J, et al. Efficacy of flibanserin
100mg qhs as a potential treatment for Hypoactive Sexual Desire
Disorder in North American pre-menopausal women. Abstract accepted to
the European Society of Sexual Medicine Congress, November 2009.

[7] Nappi R, Dean J, van Lunsen H, et al. Efficacy of flibanserin
as a potential treatment for Hypoactive Sexual Desire Disorder in
European pre-menopausal women: Results from the ORCHID trial.
Abstract accepted to the European Society of Sexual Medicine
Congress, November 2009.

[8] Jolly E, Clayton AH, Thorp J, et al. Safety and tolerability
of flibanserin in pre-menopausal women with Hypoactive Sexual Desire
Disorder. Abstract accepted to the European Society of Sexual
Medicine Congress, November 2009.

ots Originaltext: Boehringer Ingelheim GmbH
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Contacts: Dr. Heike Specht, Corporate Division Communications,
Boehringer Ingelheim GmbH, 55216 Ingelheim/Germany, Mobile:
+49(151)15-02-29-30, Fax: +49(6132)77-6601,
spechthe@boehringer-ingelheim.com; Judith von Gordon, Corporate
Division Communications, Boehringer Ingelheim GmbH, 55216
Ingelheim/Germany, Mobile: +49(178)2905056,
Judith.vonGordon@boehringer-ingelheim.com