Boehringer Ingelheim announces Phase III data of flibanserin in pre-menopausal women with HSDD

Ridgefield, CT,17 nov 2009- Data from pivotal Phase III clinical trials demonstrate that flibanserin 100mg increased the number of satisfying sexual events (SSE) and sexual desire (the co-primary endpoints) while decreasing the distress associated with Hypoactive Sexual Desire Disorder (HSDD). Flibanserin is an investigational compound being developed by Boehringer Ingelheim for the treatment of HSDD in pre-menopausal women. HSDD is a decrease or lack of sexual desire that causes distress for the patient, may put a strain on relationships with partners, and is not due to the effects of a substance, including medications, or another medical condition.

The findings, presented at the 12th Congress of the European Society for Sexual Medicine in Lyon, France, include data from a pre-specified pooled analysis of two pivotal North American trials (DAISY® and VIOLET®) assessing flibanserin 100mg in pre-menopausal women suffering from HSDD.

"HSDD is a complex condition that can cause distress and negatively impact a woman's self-esteem," said Anita Clayton, MD, one of the lead study authors and professor of psychiatry and neurobehavioral sciences, University of Virginia. "With this data, we are making exciting progress in women's sexual health research, as flibanserin is the first in a class of drugs being studied for this condition in pre-menopausal women. This is an important milestone for an under-recognized condition for which there is no FDA-approved treatment."

North American Phase III Trial Results

In the pooled analysis of 1,378 pre-menopausal women with HSDD, the frequency of SSE increased significantly in women taking flibanserin 100mg (increasing from 2.8 at baseline to 4.5 at study end) versus placebo (2.7 at baseline increasing to 3.7 at study end) over the 24-week study period. Flibanserin also demonstrated statistically significant improvements in sexual desire versus placebo as measured by a daily electronic diary (eDiary) and the Female Sexual Function Index (FSFI) desire domain.

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 (the score on FSDS-R question 13) versus placebo, which were secondary endpoints.

The most commonly reported adverse events (AEs) with flibanserin 100mg were mild to moderate and emerged during the first 14 days of treatment. These AEs reported by more women on flibanserin than on placebo included somnolence (daytime sleepiness), dizziness, fatigue, anxiety, dry mouth, nausea and insomnia. The majority of these AEs resolved with continued treatment. About 15 percent of women on flibanserin 100mg and seven percent of women on placebo discontinued treatment due to AEs.

"Sexual desire disorders can affect women of all ages, at any stage of life," said Peter Piliero, MD, executive director, Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "Boehringer Ingelheim is pleased to present this data, which provides valuable scientific knowledge about HSDD."

About the North American Phase III Trial

The North American Phase III clinical trial studied flibanserin at 25, 50 and 100mg doses. The pre-specified pooled analysis included data from two 24-week randomized, placebo-controlled North American trials. The analysis involved women with generalized, acquired HSDD who were treated with flibanserin 100mg or placebo. Flibanserin 100mg increased the number of SSE and sexual desire and decreased distress associated with HSDD. The women in the study were in stable, communicative, monogamous, heterosexual relationships with a sexually-functional partner for at least one year and were required to use a reliable form of contraception. About 40 percent of women were on some form of hormonal contraception.

In the North American pivotal trials, the co-primary endpoints were changes from a four-week baseline period to week 21 to 24 in sexual desire score and in the number of SSE, as recorded daily by patients using an electronic diary (eDiary For HSDD Trials). Both are patient reported outcome measures. SSE measures the number of sexual events (defined as sexual intercourse, oral sex, masturbation or genital stimulation by the partner), and whether each event was satisfying for the woman (i.e. gratifying, fulfilling, satisfactory and/or successful).

The FSFI and FSDS-R desire scores - independently developed and validated tools - were included as secondary endpoints to provide additional measurement of changes in desire over a four-week recall period. The FSFI is a 19-item self-administered questionnaire composed of six domains (desire, arousal, lubrication, orgasm, satisfaction, and pain). The FSDS-R is a 13-item self-administered questionnaire. The total score ranges from zero to 52, with the higher scores indicating more sexual distress. Additionally, Boehringer Ingelheim designed the eDiary For HSDD Trials to measure levels of desire on a daily basis.

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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-TR), HSDD is the persistent lack (or absence) of sexual fantasies or desire for any form of sexual activity causing marked 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 or psychiatric condition. Generalized, acquired HSDD is not limited to certain types of stimulation, situations or partners, and develops only after a period of normal functioning. Sexual Desire Disorders are generally under-diagnosed.