1. Angelique Diaz March 15, 2016
HED 220 Professor Philip A. Belcastro
Flibanserin
Our Modern Day Female Viagra
Flibanserin is a drug closely related to the idea of what we know as today's viagra.
Instead, flibanserin is made for our everyday women. Originally the drug was designed and
tested for use as an antidepressant. When concluding its original findings though, flibanserin
found a new purpose. The drug was found and now serves as relief for premenopausal women
suffering with Hypoactive Sexual Desire Disorder (HSDD). Much controversy came about as
flibanserin made its push for approval. Many people wondered how significant the drug's
effectiveness was compared to its placebo, as the numbers were not to far apart in change.
Whether HSDD could even be considered a real disorder also stirred things up. The serious risks
associated with taking flibanserin have also been a key aspect in the drugs long journey to
approval. The drugs biggest push came from a feminist movement led by Even the Score.
Whether or not flibanserin was approved to appease the feminist or for major profit, some
women may now have a way out of such a distressing disorder.
Diagnosing Hypoactive Sexual Desire Disorder is a bit complicated as many factors are
involved. In comparison to some Male Sexual Disorders, it’s not as simple as just getting it up.
In the Diagnostic and Statistical Manual of Mental Disorders, HSDD is defined as “a deficiency
or absence of sexual fantasies and desire for sexual activity. The disturbance must cause marked
distress or interpersonal difficulty.” Critical to a diagnosis is the subjective judgment of the
health care provider. “ The diagnosis must rely on clinical judgment based on the individual's
characteristics, the interpersonal determinants, the life context, and the cultural setting.” Desire

2. to have sex is also a variable on a day to day basis. This is based on stressors occurring, other life
events, and neuroendocrine functions. (Kingsberg 2011)
There are many risk factors associated with developing HSDD. These include being in an
active relationship, emotional or mental health issues, physical health conditions, aging or the
medication you take. A study by Haynes RD in an 2008 publication found that relationship
factors were probably the most important risk factor when it comes to a decrease in sexual
desires. Low sexual desire was reported more often in women in stable, long-term relationships
(20-29 years). In addition, they found that sexual distress was positively associated with
depression and inversely associated with better communication of sexual needs (Kingsberg
2011). Physical health conditions that can influence sexual desire are diabetes, arthritis, heart
disease or hypothyroidism. Medications that can interfere with sexual desire consist of
morphine, codeine, chemotherapy drugs and some psychoactive drugs (Hook 2010).
One would think there would be a drug on the market for this kind of disorder, but there
wasn’t. Quite humorous though is that flinbasersin never intended to be one. Flibanserin was
created by Boehringer Ingelheim, a German Pharmaceutical company. The drug was originally
being created as an antidepressant. After testing, such was found to be a poor treatment for
depression. While the female subjects were being questioned about their trial experience, many
women reported more sexual interest and overall satisfying sexual experiences. This effect was
so prominent for some women that they didn't want to stop testing based on this fact
(“Flibanserin, a Medical,” 2015). The positive effects the women had on their sexual interest
vastly overshadowed any effects on the depression they suffered. With these findings,
Flibanserin started its journey to becoming the first female drug to treat sexual dysfunction.

3. By no means was this journey easy. Flibanserin is commonly known as the thrice failed
drug. In 2009 the Begona trials began. Begonia was a multicenter, randomized double-blind
placebo-controlled trial, which included a 4-week baseline period followed by a 24-week
treatment period and a 10 week post-treatment period (Katz, et al). Company funded evidence n
2010 showed that at best compared with placebo, the drug might offer less than one extra
“satisfying sexual event” a month, and an FDA analysis found neither of the two pivotal studies
“met the agreed-upon criteria for success in establishing the efficacy of flibanserin.” The analysis
also found common side effects included nausea dizziness,fatigue,sleepiness and sedation,
causing almost 15% of women taking the drug to drop our of clinical trials. Furthermore the
trials showed an increased frequency of rare but serious adverse events including depression
mental injury and fainting (Moynihan 2014). We can see why flibanserin didn't work for
depression now. Nonetheless, the FDA rejected the drug and back to drawing board it was.
Boehringer Ingelheim sold flibanserin to Sprout Pharmaceuticals in 2011. Pretty soon
after testing began, with not much change compared to the drugs first trial. A variety of safety
concerns were raised during the 2013 FDA review. These included a risk of hypotension, causing
some women to temporarily lose consciousness, and severe sleepiness or drowsiness among
users of the product. Additionally there was the potential for adverse effects when flibanserin is
taken with alcohol or oral contraceptives. The drug was to be taken at bedtime to minimize the
consequences of sedation-related adverse effects. Still the risk of hypotension-related adverse
events were higher with flibanserin vs placebo. In addition, the trials were limited to generally
healthy women not taking benzodiazepines, sleep aids, narcotics, or a number of other
medicines. As with many trials, they were also of short duration relative to the potential length of

4. time that flibanserin could be indicated. Given these concerns, the FDA once again rejected
flibanserin and recommended additional safety studies (American Medical Association 2015).
By no means did this defeat discourage Sprout Pharmaceuticals from pushing to get
flibanserin approved. A sponsor of flibanserin provided additional safety data. The data included
a study suggesting the absence of next-day driving impairments, a comparison if the products
adverse effect profile with that of other market products, and an analysis confirming the
potentiating effects of alcohol on adverse events. Although the driving study was reassuring,
isolated comparisons of safety across products can be misleading because FDA products reviews
are not fundamentally comparative in nature. Quite interesting though, is the alcohol interaction
study took place in a sample of 25 healthy volunteers, only 2 of whom were women (American
Medical Association 2015).
A major issue for the committee regarded to flibanserin relation to its likelihood of use in
clinical practice. Although there are a few reliable estimates of the prevalence of HSDD, the
product, as with others, is all but certain to be used off-label among a broader population of
women than has been studied. The concerns about off-label use were reinforced by public
speakers at the meeting who expressed their need for flibanserin, while at the same time
reporting conditions that may have excluded them from on-label treatment, such as a cancer
diagnosis or postmenopausal status (American Medical Association 2015).
Many of these women would not fulfill formal diagnostic criteria for HSDD and many of
whom may have conditions or concomitant medication use that increases the risk of adverse
events (American Medical Association 2015). Diagnosing HSDD is already pretty difficult, on
top of the arguable question of whether or not it is a real disorder. Although desire problems are
real and can be debilitating the idea of a common disorder of desire is now discredited. The

5. construct of HSDD has in fact been removed from the latest edition of the Diagnostic and
Statistical Manual of Mental Disorders. It now includes a new construct called sexual
interest/arousal disorder designed to more accurately reflect the complexity of women’s sexual
experience. With much stricter diagnostic criteria prevalence estimates are likely to be a fraction
of the 10% claimed for HSDD. The changes are in part to “reduce the likelihood of
overdiagnosis’ says the American Psychiatric Association (Moynihan 2014). Real disorder or
not, Sprout was not giving up without a fight.
With Sprouts last attempt to get the drug approved, they went a different route. Instead
they used a public relations campaign called Even The Score. The campaign was run by public
relations firm Blue Engine Message and Media. They accused the FDA of sexism by claming
that there were 26 FDA-approved sexual dysfunction drugs for men and zero for women. As a
matter of fact the FDA had approved eight drugs for sexual dysfunction in men and three for
women. With that being said, the FDA has yet to approve a single libido-boosting drug for either
men or women. Yet the group emphasizes it feminist language around rights, choice and sex
equality despite the still questable fact of whether the drug is significantly effective. Seeing as
“libido” can be highly subjective to its relation to other factors such as relationship or age,
Sprout used what they could (Berman, Hirsch 2015).
Sprout “paraded” women before the FDA who stated that they were afraid their
marriages would fail if they didn’t improve their libido. Many spoke of feeling broken,
implicating that flibanserin would be the only solution to their problem. Viagra has been the
leading compared drug throughout this process, but Berman and Hirsch point out is that lubricant
is its counterpart in women, not flibanserin. Flibanserin does absolutely nothing for real sexual
dysfunction, including pain, vaginal dryness, and inability to reach orgasm. Another good point

6. Berman and Hirsch made is that the erectile dysfunction approved for men have been
significantly proven to work. Moreover, flibanserin proved to only increase sexual satisfying
events by less than one event per month; fewer than eight events a year. Could it be that a
campaign built on sexual equality is in fact come to be contradictingly sexist, as its holding
flibanserin to a lower standard or safety and efficacy (Berman, Hirsch 2014)?
Ray Moynihan put Even The Score to the test by interviewing its chairman Susan
Scanlan. Scanlan stressed that she was not a medical expert or statistician, adding, “I am an
ignoramus when it comes to chemical issues.” She said that when deciding whether to get
involved with Even the Score, she had relied heavily on advice from others, mainly an
organisation called the American Sexual Health Association (ASHA). Also informing Scanlans
decisions to support the campaign were meetings with patients with sexual dysfunction. To no
surprise ASHA and Sprout were the ones who arranged these meetings. In virtually every case,
the advice that has convinced a long time feminist to lend her credibility to this campaign was
from sources with financial ties to drug companies, or from people paid by Sprout. Sprout
representatives also met several times with the National Women's Health Network but failed to
persuade its members to support the drug. On the other hand, the network joined several other
health organisations, writing a strongly worded letter to the FDA supporting their evidence based
evaluation and rejection of flibanserin. “The problem with flibanserin”said the letter “is not
gender bias at the FDA but the drug itself.” The letter continued to say “the concept of Even the
Score resonates in the heart of every woman who has ever felt things aren’t quite fair. That sense
of injustice is real, but it is misused so badly by this campaign (Moynihan 2015).”
Despite the negative controversy and what seemed like a disastrous journey, flibanserin
was approved by the FDA on August 18, 2015. Addyi, which contained 100 mg of flibanserin,

7. was deemed a once-daily, non-hormonal pill for the treatment of acquired, generalized
hypoactive sexual desire disorder in premenopausal women. Sprout Pharmaceutical Chief
Executive Officer Cindy Whitehead quotes, “with our availability nationwide today, we are
proud of our affordable and innovative programs to offer Addyi for as little as $20 per
prescription.” Sprout will offer two avenues of affordable access for women, including the Addyi
Affordable Access Card for pharmacies and the Addyi Direct program with doorstep delivery.
Addyi is available through certified health care prescribers and pharmacies enrolled in the Addyi
Risk Evaluation and Mitigation Strategy program (Sprout Pharmaceuticals, 2015).
Flibanserin may very well be the first drug approved through a public relations campaign.
Soon after being rejected as an antidepressant testing began, instead, as a treatment for HSDD.
Twice after, the drug was again rejected by the FDA due to lack of efficacy and pretty steep
health risk. Sprout then deterred from the science of the drug and used a feminist campaign Even
the Score to put pressure on the FDA. Essentially flibanserin became the poster child for sexual
dysfunction medication and its absence in the female community. A quite scandalous and long
journey eventually did end up it the drug's approval. Prescription name Addyi is now available to
women suffering HSDD.
Bibliography
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