2009-11-16

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 demonstratethat flibanserin 100mg taken once daily at bedtime significantlyincreased the number of Satisfying Sexual Events (SSEs) and sexualdesire while significantly decreasing the distress associated withHypoactive Sexual Desire Disorder (HSDD).[1] Flibanserin is aninvestigational compound that is being developed by BoehringerIngelheim for the treatment of pre-menopausal women with HSDD.

To view the Multimedia News Release, please click:http://multivu.prnewswire.com/mnr/prne/boehringeringelheim/39236

HSDD is a medical condition characterised by a decrease in sexualdesire associated with marked distress and/or interpersonaldifficulties.[2] Women with HSDD often feel a loss of intimacy andcloseness that they used to enjoy. The condition can negativelyimpact a woman's life and her relationship with herpartner.[2],[3],[4],[5]

The complete flibanserin pivotal trial programme was presentedtoday at the 12th Congress of the European Society for SexualMedicine in Lyon, France. It included an analysis of three pivotalPhase III North American trials (DAISY(R), VIOLET(R) and DAHLIA(R))and the pivotal Phase III European data (ORCHID(R)). In additionresults from a pooled analysis of two pivotal Phase III NorthAmerican trials (DAISY(R) and VIOLET(R)) and a pooled analysis of theNorth American and European data (DAISY(R), VIOLET(R) and ORCHID(R))were presented, assessing the safety and efficacy of flibanserin100mg in pre-menopausal women suffering with HSDD.

"Despite studies demonstrating that HSDD is a common form offemale sexual dysfunction, there is currently no approvedprescription treatment for pre-menopausal women suffering from thecondition" said Professor Rossella Nappi, director of theGynaecological Endocrinology & Menopause Unit at the MaugeriFoundation, University of Pavia, Italy, and primary investigator ofthe European pivotal trial. "Flibanserin is a novel, non-hormonalcompound, that has been investigated as a treatment forpre-menopausal women with HSDD. Based on the clinical trial resultspresented at ESSM it has the potential to help many women sufferingfrom their lack of sexual desire."

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

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

Other key secondary endpoints showed flibanserin significantlyimproved sexual functioning (as measured by the FSFI total score),distress related to sexual dysfunction (as measured by the FemaleSexual Distress Scale-Revised, FSDS-R, score) and distress related tolow 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 womentaking flibanserin 100mg had statistically significant improvementsin their level of sexual desire, as measured by the eDiary. Thesefindings were supported by a trend towards an increase in the FSFIdesire domain. In addition there was a statistically significantimprovement in the level of distress associated with sexualdysfunction (as measured by the FSDS-R total score) as well asdistress related to low sexual desire (FSDS-R Item 13) which is thesecond key parameter for the diagnosis of HSDD. A numerical increasein the number of SSEs compared to placebo supports the efficacy offlibanserin in pre-menopausal women suffering with HSDD.

North American and European Phase III Trial Results - PooledAnalysis (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) andVIOLET(R)) reinforces the efficacy of 100mg flibanserin for thetreatment of pre-menopausal women with HSDD. Results show astatistically significant improvement versus placebo in the number ofSSEs, as well as a statistically significant increase in the level ofsexual desire, recorded via the eDiary and the FSFI desire domainscores. Distress associated with sexual dysfunction and specificallylow 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 tomoderate, emerged during the first 14 days of treatment and resolvedwith continued treatment. The most common adverse events (AEs)reported by more women on flibanserin than on placebo includeddizziness, nausea, fatigue, somnolence and insomnia. The findings areconsistent across the North American and European trials with about14% and 16% of women on flibanserin 100mg and 8% and 5% of women onplacebo discontinuing treatment due to AEs in the respective trials.

"Findings from the pivotal Phase III trials show that flibanserin100mg is effective and well-tolerated for the treatment of HypoactiveSexual Desire Disorder in pre-menopausal women," said Elaine Jolly,Medical Director, Shirley E. Greenberg Women's Health Centre of theOttawa Hospital and Professor of Obstetrics and Gynecology,University of Ottawa, and one of the Canadian physiciansparticipating in the Phase III trials. "Flibanserin acts as anagonist at the serotonin 5-HT1A receptor and as an antagonist at the5-HT2A receptor with preferential affinity to selective brain areas.It is believed to act on neurotransmitters within the brain that arethought to play a role in sexual response. By modulating theseneurotransmitter systems, flibanserin may help to restore a balancebetween inhibitory and excitatory factors leading to a healthy sexualresponse."

Notes to Editors:

This release is from Boehringer Ingelheim Corporate Headquartersin Germany. Please be aware that there may be national differencesbetween countries regarding specific medical information, includinglicensed uses. Please take account of this when referring to theinformation provided in this document. This press release is notintended for distribution within the U.S.A.

Please be advised that further background information on thesubject of this press release can be accessed via the BoehringerIngelheim 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 flibanserin100 mg qhs as a potential treatment for Hypoactive Sexual DesireDisorder in pre-menopausal women. Abstract accepted to the EuropeanSociety of Sexual Medicine Congress, November 2009.

[2] Sexual and gender identity disorders. In: AmericanPsychiatric Association. Diagnostic and Statistical Manual of MentalDisorders. 4th ed. Washington, DC: American Psychiatric Association;2000:493-538

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

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

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

[6] Jolly E, Clayton AH, Thorp J, et al. Efficacy of flibanserin100mg qhs as a potential treatment for Hypoactive Sexual DesireDisorder in North American pre-menopausal women. Abstract accepted tothe European Society of Sexual Medicine Congress, November 2009.

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

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

ots Originaltext: Boehringer Ingelheim GmbHIm 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

Boehringer Ingelheim GmbH

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

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