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Switch to Forum Live View FDA Approves Flibanserin — So-Called ‘Female Viagra’
2 years ago  ::  Aug 17, 2015 - 10:31AM #1
Merope
Posts: 14,591

The FDA is expected to decide early this week — possibly as early as tomorrow — whether to approve the world's first drug designed to boost a woman's sexual desire.  The drug is designed to help pre-menopausal women with Hypoactive Sexual Desire Disorder (HSDD).


While drugs like Viagra target blood flow, flibanserin targets the brain.  Thus flibanserin's regulatory path has been a rocky one, in part because the science of desire is little understood, and in part because there is disagreement on what constitutes "normal" sexual desire.  Once a host of other common factors for flagging desire are ruled out — medical conditions, sex-hormone depletion, relationship troubles, some antidepressants, cultural or religious messages, poor body image — questions remain.


Is it mismatched libido with a partner with a higher sex drive, as some contend?  Is monogamy just boring?  Or is it biology?  And the biggest question: how will the availability of flibanserin change the nature of sex, relationships, and intimacy?  And, uh, were any of these questions asked during the Viagra approval process?


www.washingtonpost.com/news/to-your-heal...

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2 years ago  ::  Aug 17, 2015 - 12:54PM #2
MMarcoe
Posts: 20,907

Targeting the brain is probably a better idea overall, because we all know the brain is the most important sex organ.


That goes for men. Folks love to think that sexual arousal is a simple matter of a working penis for men, but it's not. We're also affected by emotions, context, relationship issues, and all the other things women are affected by.


If this new drug can either affect those factors for the better or else circumvent them entirely, then maybe it's worth trying. It might even unintentionally enhance intimacy.

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2 years ago  ::  Aug 20, 2015 - 10:51PM #3
Merope
Posts: 14,591

The FDA approved flibanserin on Tuesday.  It is the first-ever prescription drug treatment for low sexual libido in women.  The highly controversial drug is brand-named Addyi and is produced by Sprout Pharmaceuticals.  It will be on the market this October, according Sprout's CEO.


Advocates of the drug say the approval is a triumph for many researchers—and patients—who have argued that a pervasive gender bias has prevented the approval of treatments for low sexual desire in women, while men continue to have a growing number of options.


But the FDA has rejected flibanserin twice before.  After a hearing in June, an FDA panel voted 18-6 in favor of putting flibanserin on the market but emphasized that the drug manufacturer would be required to include certain safety warnings when the drug is marketed in the US. Experts who oppose the drug’s approval say studies demonstrated it isn’t safe for long-term use.


Flibanserin, which has been evaluated in a total of 68 trials and on more than 10,000 women, has been associated with a number of side effects, including nausea, dizziness, and sleepiness. Moreover, an evaluation of the drug’s interaction with alcohol showed that flibanserin could cause hypotension and dizziness in some patients who drink, which Sprout's CEO says will be made clear when the drug is sold to consumers.   


In addition to efficacy trials, Sprout also conducted a number of “challenge studies,” which are a closer evaluation of specific negative side effects reported in earlier studies.  The company examined the drug’s potential to cause sleepiness by conducting a next-day driving impairment study, which produced unremarkable results.  


www.newsweek.com/flibanserin-female-viag...

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2 years ago  ::  Aug 20, 2015 - 10:57PM #4
Merope
Posts: 14,591

Other critics argue that the drug isn’t effective enough.  Clinical trials show that flibanserin only increased the frequency of satisfying sexual events by 2 or 3 per month.  But Sprout’s CEO says that finding is statistically significant.  More importantly, she says, a large number of patients reported the drug reduced levels of distress associated with hypoactive sexual desire disorder (HSDD), a condition that is included in the Diagnostic and Statistical Manual of Mental Disorders 5.  HSDD is defined as a persistent or recurrent disinterest in sexual fantasies or desire for sexual activity that also puts a strain on a woman’s life and interpersonal relationships; the condition is unrelated to other factors such as medical issues, substance abuse or psychiatric illness.


study published in the Archives of Internal Medicine in 2008 found 26.7% - 52.4% of premenopausal women experienced low sexual desire at some point in their lifetimes.  According to Sprout’s CEO, the average age of a patient diagnosed with HSDD is 36, and most struggle with the condition for 4 to 5 years before receiving a diagnosis.  June’s panel hearing included testimonials from more than 30 people, many of whom were women who offered first-person accounts on coping with HSDD.


Sprout’s CEO notes that the reason some women lose desire is now supported by science.  Brain scans of women with normal sexual response show a lighting up of the prefrontal cortex during arousal, followed by a “quieting” once the event takes place.  Brain scans of women with HSDD don’t demonstrate the same process, she says.


Sprout’s CEO says approval of the drug will hopefully also mark a shift in the way the medical community understands sexual desire.  


www.newsweek.com/flibanserin-female-viag...

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2 years ago  ::  Aug 20, 2015 - 11:01PM #5
Merope
Posts: 14,591

Flibanserin is not the female equivalent of Viagra, despite the way it has been positioned by many.  Viagra, initially developed as a cardiovascular drug, increases blood flow to the penis, but does not cause sexual arousal.  Flibanserin, on the other hand, is a nonhormonal drug that works by targeting the neurotransmitters dopamine and noradrenaline, while lowering levels of serotonin—all of which are part of the central nervous system’s sexual response.  It was originally developed as an antidepressant.  However, in early trials, researchers discovered that while the drug didn’t effectively alleviate symptoms of depression, it did have a positive impact on libido in some women.  Some researchers wonder if flibanserin could be useful to men as well, but this has yet to be studied.


According to Sprout's CEO, conversations with insurance companies have been promising.  Most providers tell the company they are willing to offer coverage for flibanserin that is on par with Viagra, Cialis, and other erectile dysfunction drugs.  Most insurance companies will fill a monthly prescription for at least half a dozen erectile dysfunction pills—if not more.  Whitehead said depending on what insurance plan a person has, she can expect to pay anywhere between $30 to $75 a month for the medication, which needs to be taken every day in order to be effective.


Dr. Kenneth Paul Rosenberg, associate clinical professor at Cornell Weill Medical College, says he will be glad to have flibanserin in his arsenal of potential treatments for the patients he sees at his private practice in New York.  But in his clinical experience, Rosenberg has found talk therapy can provide the same or an even better outcome than what has been reported in studies on flibanserin.


He stresses that it will be important for health care providers to conduct a thorough evaluation before prescribing the drug to a patient.  “Medicines are great but you really want to make sure they give them at the right time and the right reason and judiciously,” he says.  “I think time will tell how efficacious it is, what the side effect profile is, and how the cost compares to benefits.  But the general principle of having a prosexual drug for women is long overdue.”


www.newsweek.com/flibanserin-female-viag...

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2 years ago  ::  Aug 21, 2015 - 6:53PM #6
rideronthastorm
Posts: 9,223

Its something I surely dont need.

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2 years ago  ::  Aug 29, 2015 - 2:04PM #7
Merope
Posts: 14,591

This thread was moved from the Hot Topics Zone.

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