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Boehringer Ingelheim's sexual desire drug for women hits the spot
 
 
  19 May 2010
pharmatimes.com
 
Boehringer Ingelheim has posted interesting late-stage data for its female sexual dysfunctional drug flibanserin which suggests that the treatment increases satisfaction.
 
Data from two Phase III trials run in North America were presented at the American College of Obstetricians and Gynaecologists annual meeting in San Francisco. They demonstrate that a higher proportion of pre-menopausal women with hypoactive sexual desire disorder receiving flibanserin 100mg "reported both an improvement in their condition and a meaningful benefit from their treatment, compared to placebo".
 
The analysis included 1,378 pre-menopausal women with HSDD who were evaluated about "bothersome decreased sexual desire" using a seven-point scale from 1 (very much improved) through 4 (no change) to 7 (very much worse). After 24 weeks, 48.3% of women receiving flibanserin and 30.3% on placebo reported feeling very much improved, much improved or minimally improved . In addition, more women on the Boehringer drug reported experiencing a meaningful benefit from the study medication (40.5% versus 25.2%).
 
Study investigator John Thorp of the University of North Carolina Medical School said the data "offer a unique perspective on the effects of flibanserin from the patient's point of view". Not only did the women feel an improvement "in their symptoms of low desire and associated distress when taking flibanserin, but they also reported that this change had a meaningful benefit to them".
 
These latest findings add to data from other pivotal trials which have shown that flibanserin demonstrated statistically significant improved measures of sexual desire, overall sexual functioning, distress associated with the condition and the number of satisfying sexual events, compared with placebo.
 
Flibanserin, an oral treatment that was originally developed as an antidepressant, affects levels of serotonin and other chemicals in the brain but how it affects sex drive remains unclear. In mid-June, an advisory panel of the US Food and Drug Administration will vote on whether to recommend approval.
 
Given the nature of HSDD, it is unsurprising that flibanserin is being referred to in some media circles as 'female Viagra'. However, Paula Hall, a sexual and relationship psychotherapist from the UK, said that although HSDD affects thousands of women, "it is often misunderstood or overlooked". She added that 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."
 

press announcement
 
Boehringer Ingelheim Announces New Data on Flibanserin in Pre-Menopausal Women with Hypoactive Sexual Desire Disorder
 
- New analyses from pivotal Phase III flibanserin trials presented today -
 
Ridgefield, CT, May 18, 2010 -Data from pivotal Phase III clinical trials demonstrate that a higher proportion of pre-menopausal women with Hypoactive Sexual Desire Disorder (HSDD) receiving flibanserin 100mg reported both an improvement in their condition and a meaningful benefit from their treatment, compared to placebo. Flibanserin is an investigational compound being developed by Boehringer Ingelheim Pharmaceuticals, Inc. for the treatment of HSDD in pre-menopausal women. HSDD is a persistent or recurrent 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 58th Annual Clinical Meeting of the American College of Obstetricians and Gynecologists in San Francisco, 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.
 
"These new data offer a unique perspective on the effects of flibanserin 100 mg from the patient's point of view. Not only did pre-menopausal women with HSDD report feeling an improvement in their symptoms of low desire and associated distress when taking flibanserin, but they also reported that this change had a meaningful benefit to them," said John Thorp, MD, study investigator, Professor of Obstetrics and Gynecology, University of North Carolina Medical School.
 
These findings add to data from the primary and secondary endpoint analysis of flibanserin pivotal trials. According to the pre-specified pooled analysis of women who completed 24 weeks of treatment, flibanserin 100mg showed statistically significant improved measures of sexual desire, overall sexual functioning, distress associated with low sexual desire, and the number of satisfying sexual events (SSE), compared with placebo.
 
"HSDD is an under-recognized and often misunderstood condition that can take a toll on women," said Peter Piliero, MD, executive director, Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "We are committed to advancing flibanserin's development to help understand and find a treatment for women affected by this distressing medical condition."
 
North American Phase III Trial Results
 
Patient Perspective Analysis

 
The pooled analysis included 1,378 pre-menopausal women with HSDD treated with either flibanserin 100 mg or placebo for 24 weeks. The women evaluated their overall improvement in "bothersome decreased sexual desire" using the Patient's Global Impression of Improvement (PGI-I), which is a 7-point scale from 1 (very much improved) through 4 (no change) to 7 (very much worse). By 24 weeks, 48.3 percent of women receiving flibanserin and 30.3 percent of women receiving placebo reported feeling very much improved, much improved or minimally improved (p<0.0001).
 
In addition, more women in the flibanserin group versus placebo reported experiencing a meaningful benefit from the study medication (40.5 percent versus 25.2 percent, respectively; p<0.0001), using a single-question Patient Benefit Evaluation (Overall, do you believe that you have experienced a meaningful benefit from the study medication?).
 
Analysis of Completers
 
The pooled analysis included 971 (flibanserin 100 mg qhs: 450; placebo: 521) pre-menopausal women who completed the 24-week trials. In that analysis, flibanserin 100mg significantly increased the frequency of SSE versus placebo (increase of 2.1 events vs. 0.9 events, respectively; p<0.0001) over the 24-week study period. The analysis also found that, compared with placebo, flibanserin 100 mg showed statically significant improved measures of sexual desire using an electronic daily diary or eDiary (primary endpoint) and on the Female Sexual Function Index (FSFI) desire domain (secondary endpoint). Compared with placebo, flibanserin also showed statistically significant improved sexual functioning (as measured by the FSFI total score), and distress related to low sexual desire (based on the Female Sexual Distress Scale-Revised, FSDS-R, total score), which were secondary endpoints.
 
The FSFI and FSDS-R desire scores are independently developed and validated tools that 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.
 
Pivotal Trials Safety Data
 
The most commonly reported adverse events (AEs) with flibanserin 100mg in the pivotal North American trials 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.
 
About Flibanserin
 
Flibanserin is an investigational compound being developed by Boehringer Ingelheim for the treatment of HSDD in pre-menopausal women. Pooled data from pivotal phase III trials demonstrated that flibanserin 100mg increased the number of satisfying sexual events (SSE) and sexual desire while decreasing the distress associated with HSDD. 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.
 
About Hypoactive Sexual Desire Disorder
 
Low sexual desire is the most commonly reported female sexual complaint. Approximately one in 10 women report low sexual desire with associated distress, which may be HSDD. HSDD is a form of female sexual dysfunction (FSD) and has been recognized as a medical condition for more than 30 years. As defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR), HSDD is the persistent or recurrent 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. There is an unmet need for women as there is no FDA-approved treatment for HSDD. It can affect women of all ages and at any stage of life.
 

media announcement from Boerhinger Ingelheim
 
When it Comes to Sparking a Woman's Sexual Desire, Most Men - and Even Women - May Not Know Where to Start
 
- Actress Lisa Rinna kicks off campaign highlighting connection between brain, body and sexual desire -
 
Washington, D.C., May 12, 2010 -When it comes to sex, more than half of men and women don't recognize the brain as an important female sexual organ, according to a new survey.*
 
"The root of a woman's desire is complex, but it is thought to start with her brain. The brain is the center for thoughts and emotions, but it is also home to a complex system of nerves, hormones and other chemicals that can affect sexual desire," said Laura Berman, LCSW, Ph.D., and sex and relationship expert.
 
Interestingly, the survey revealed that women and men's feelings about sex and sexual desire are more alike than people may think, as they both agree that sexual health is important for a woman's overall health and well being. Yet, while most women surveyed would be concerned if they experienced, and most men would be concerned if their partner experienced, a decrease in sexual desire, less than half of both women and men have ever discussed these issues with their partner.
 
Today, the Society for Women's Health Research (SWHR), along with actress and TV personality Lisa Rinna, launched "Sex Brain Body: Make the Connection," a new educational campaign about female sexual health, particularly about the role the brain is thought to play in female sexual desire.
 
"As a woman, wife and mother, I know that women's sexual desire can fluctuate. For some women that's normal, but for others it may be something more," Rinna said. "Everyone is entitled to a healthy sex life. That's why I'm encouraging women to learn more about their sexual health and the brain's potential role in desire, so they can talk more openly about it with a partner and health care provider. By visiting www.SexBrainBody.com, I want to empower women to learn more about their sexual health and better understand sexual desire."
 
Experts believe that chemicals in the brain may play a role in sexual response, impacting a woman's sexual desire. Women and men surveyed believe that desire is important for a healthy sex life, and that a decline in a woman's desire would be distressing to the woman. Yet, few people realize that a lack of sexual desire accompanied by distress might be something more than stress from a demanding career or family commitments. It may be a medical condition known as Hypoactive Sexual Desire Disorder, or HSDD.
 
By visiting www.SexBrainBody.com, women can learn more about HSDD, as well as find helpful tips for starting what may be an uncomfortable conversation with their partners or health care providers about their sexual health and any issues they may be experiencing.
 
"For 20 years, SWHR has provided resources and knowledge to empower women to take control of their health. We are proud to be supporting this campaign to help women understand their sexual health and give them the confidence to discuss their needs," said Phyllis E. Greenberger, M.S.W., President and CEO of SWHR in Washington, D.C.
 
Survey Findings
 
The "Sex Brain Body: Make the Connection" survey included 1,300 women ages 30 to 55 years and 1,129 men ages 30 to 65 years. The survey was designed to explore the attitudes and behaviors of women regarding their sexual health, as well as men's perception of a woman's sexual health.
 
Highlights of the survey include the following:
 
* Nearly 75 percent of women report experiencing a lack of sexual desire at least occasionally, with 20 percent reporting a lack of desire frequently
 
* Both women and men believe a woman's lack of desire for sex would cause distress in a relationship (78 percent women, 63 percent men); more than half of women and men say that a lack of desire would have a negative impact on their relationship
 
* Most women (roughly 60 percent) say they would discuss low sexual desire with their health care provider, yet only 14 percent have actually done so
 
* More women would rather discuss other health topics such as allergies, skin care, hair loss and weight issues with their health care provider than talk about their sexual health
 
* Women are seven times more familiar with erectile dysfunction (66 percent) than Hypoactive Sexual Desire Disorder (HSDD) (9 percent)
 
About "Sex Brain Body: Make the Connection"
 
"Sex Brain Body: Make the Connection" is an educational campaign meant to help women recognize the potential links between the brain, the body and sexual desire, so they can better understand and address their own sexual health. The campaign is sponsored by the Society for Women's Health Research and content was developed with the support of a sponsorship from Boehringer Ingelheim Pharmaceuticals, Inc. To learn more about the sex-brain-body connection, visit www.SexBrainBody.com.
 
Low sexual desire is the most commonly reported female sexual complaint. Approximately one in 10 women reported low sexual desire with associated distress, which may be HSDD. HSDD is a form of female sexual dysfunction (FSD) and has been recognized as a medical condition for more than 30 years. As defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR), HSDD is the persistent or recurrent 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. There has been an unmet need for women as there is no FDA-approved treatment for HSDD. It can affect women of all ages and at any stage of life.
 
*About the Survey
 
A demographically representative national internet sample of 1,300 women between the ages of 30 and 55 and 1,129 men 30-65 were invited via email to participate in a 10-minute self-administered online survey. Women meeting any of the following criteria were eliminated from participating: had a full hysterectomy, currently take hormone replacement therapy, are post-menopausal and have already gone through menopause. The surveys were administered between February 8 and March 18, 2010. Data for these studies are tested for statistical difference at a confidence level of 95 percent. Data are weighted to reflect accurate representation of population.
 
About Society for Women's Health Research
 
The Society for Women's Health Research (SWHR), a national non-profit organization based in Washington, D.C., is widely recognized as the thought leader in research on sex differences and is dedicated to improving women's health through advocacy, education, and research. SWHR was founded in 1990 by a group of physicians, medical researchers and health advocates who wanted to bring attention to the myriad of diseases and conditions that affect women uniquely. Women's health, until then, had been defined primarily as reproductive health. Women were not routinely included in most major medical research studies and scientists rarely considered biological sex as a variable in their research.
 
 
 
 
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