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FDA Considering ?Little Pink Pill? for Women

By Paul Napoli

The U.S. Food and Drug Administration (FDA) will consider approval of a drug nicknamed 'Women's Viagra' which is designed to increase sexual desire in women next month, according to an article in The Washington Post.

The German pharmaceutical company of Boehringer Ingelheim first developed the drug called Flibanserin as an antidepressant, but the drug failed. However, their research showed that it had an unexpected effect on women's sex drive and they began studying its effectiveness on women with Hypoactive Sexual Desire Disorder (HSDD). HSDD is a sexual disorder characterized by a deficiency or absence of sexual fantasies and desire for sexual activity. The company says 1 in 10 women report low sexual desire with associated distress, which may be HSDD. A female libido enhancer could translate into a $2 billion market just in the United States.

'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., the U.S. subsidiary. 'We are committed to advancing flibanserin's development to help understand and find a treatment for women affected by this distressing medical condition.'

Boehringer Ingelheim presented the results of a Flibanserin Phase III clinical trial at the 58th Annual Clinical Meeting of the American College of Obstetricians and Gynecologists in San Francisco, finding that 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.

'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.

The manufacturer reports that Flibanserin side effects include somnolence (daytime sleepiness), dizziness, fatigue, anxiety, dry mouth, nausea and insomnia. The majority of these resolved with continued treatment. About 15 percent of women on Flibanserin 100mg dropped out of the study due to the side effects. Long-term side effects are unknown and like many drugs, my only show up after years of use by patients.

Low sexual desire in women can be a result of many reasons, including depression, aging, medical problems, social dysfunction or problems in a relationship. Some critics fear the promotion of HSDD as a disorder is the work of the pharmaceutical companies who seek to capitalize on it.

"Women's desire for sexual emancipation is very worthy," Leonore Tiefer, a clinical associate professor of psychiatry at the New York University School of Medicine told The Washington Post. "I fear that it's being hijacked by a profit-oriented industry that doesn't really try to understand women and their sexuality."

Originally posted at InjuryBoard by Paul Napoli

Full post as published by New York City Personal Injury Lawyer on May 26, 2010 (boomark / email).