Cheer Up Ladies! FDA Approves "Female Viagra" Pill
Female Viagra has arrived. The FDA just announced approval of Flibanserin
(brand name Addyi), the first drug ever approved to help women with a low sex
drive put a little heat between their legs.
The U.S. Food and Drug Administration today approved Addyi (flibanserin) to
treat acquired, generalized hypoactive sexual desire disorder (HSDD) in
premenopausal women. Prior to Addyi�s approval, there were no FDA-approved
treatments for sexual desire disorders in men or women.
�Today�s approval provides women distressed by their low sexual desire with an
approved treatment option,� said Janet Woodcock, M.D., director of the FDA�s
Center for Drug Evaluation and Research (CDER). �The FDA strives to protect and
advance the health of women, and we are committed to supporting the development
of safe and effective treatments for female sexual dysfunction.�
HSDD is characterized by low sexual desire that causes marked distress or
interpersonal difficulty and is not due to a co-existing medical or psychiatric
condition, problems within the relationship, or the effects of a medication or
other drug substance. HSDD is acquired when it develops in a patient who
previously had no problems with sexual desire. HSDD is generalized when it
occurs regardless of the type of sexual activity, the situation or the sexual
partner.
�Because of a potentially serious interaction with alcohol, treatment with Addyi
will only be available through certified health care professionals and certified
pharmacies,� continued Dr. Woodcock. �Patients and prescribers should fully
understand the risks associated with the use of Addyi before considering
treatment.�
Addyi can cause severely low blood pressure (hypotension) and loss of
consciousness (syncope). These risks are increased and more severe when patients
drink alcohol or take Addyi with certain medicines (known as moderate or strong
CYP3A4 inhibitors) that interfere with the breakdown of Addyi in the body.
Because of the alcohol interaction, the use of alcohol is contraindicated while
taking Addyi. Health care professionals must assess the likelihood of the
patient reliably abstaining from alcohol before prescribing Addyi.
Addyi is being approved with a risk evaluation and mitigation strategy (REMS),
which includes elements to assure safe use (ETASU). The FDA is requiring this
REMS because of the increased risk of severe hypotension and syncope due to the
interaction between Addyi and alcohol. The REMS requires that prescribers be
certified with the REMS program by enrolling and completing training. Certified
prescribers must counsel patients using a Patient-Provider Agreement Form about
the increased risk of severe hypotension and syncope and about the importance of
not drinking alcohol during treatment with Addyi. Additionally, pharmacies must
be certified with the REMS program by enrolling and completing training.
Certified pharmacies must only dispense Addyi to patients with a prescription
from a certified prescriber. Additionally, pharmacists must counsel patients
prior to dispensing not to drink alcohol during treatment with Addyi.
Addyi is also being approved with a Boxed Warning to highlight the risks of
severe hypotension and syncope in patients who drink alcohol during treatment
with Addyi, in those who also use moderate or strong CYP3A4 inhibitors, and in
those who have liver impairment. Addyi is contraindicated in these patients. In
addition, the FDA is requiring the company that owns Addyi to conduct three
well-designed studies in women to better understand the known serious risks of
the interaction between Addyi and alcohol.
Addyi is a serotonin 1A receptor agonist and a serotonin 2A receptor antagonist,
but the mechanism by which the drug improves sexual desire and related distress
is not known.
Addyi is taken once daily. It is dosed at bedtime to help decrease the risk of
adverse events occurring due to possible hypotension, syncope and central
nervous system depression (such as sleepiness and sedation). Patients should
discontinue treatment after eight weeks if they do not report an improvement in
sexual desire and associated distress.
The effectiveness of the 100 mg bedtime dose of Addyi was evaluated in three
24-week randomized, double-blind, placebo-controlled trials in about 2,400
premenopausal women with acquired, generalized HSDD. The average age of the
trial participants was 36 years, with an average duration of HSDD of
approximately five years. In these trials, women counted the number of
satisfying sexual events, reported sexual desire over the preceding four weeks
(scored on a range of 1.2 to 6.0) and reported distress related to low sexual
desire (on a range of 0 to 4).
On average, treatment with Addyi increased the number of satisfying sexual
events by 0.5 to one additional event per month over placebo increased the
sexual desire score by 0.3 to 0.4 over placebo, and decreased the distress score
related to sexual desire by 0.3 to 0.4 over placebo. Additional analyses
explored whether the improvements with Addyi were meaningful to patients, taking
into account the effects of treatment seen among those patients who reported
feeling much improved or very much improved overall. Across the three trials,
about 10 percent more Addyi-treated patients than placebo-treated patients
reported meaningful improvements in satisfying sexual events, sexual desire or
distress. Addyi has not been shown to enhance sexual performance.
The 100 mg bedtime dose of Addyi has been administered to about 3,000 generally
healthy premenopausal women with acquired, generalized HSDD in clinical trials,
of whom about 1,700 received treatment for at least six months and 850 received
treatment for at least one year.
The most common adverse reactions associated with the use of Addyi are
dizziness, somnolence (sleepiness), nausea, fatigue, insomnia and dry mouth.
The FDA has recognized for some time the challenges involved in developing
treatments for female sexual dysfunction. The FDA held a public Patient-Focused
Drug Development meeting and scientific workshop on female sexual dysfunction on
October 27 and October 28, 2014, to solicit perspectives directly from patients
about their condition and its impact on daily life, and to discuss the
scientific challenges related to developing drugs to treat these disorders. The
FDA continues to encourage drug development in this area.
Addyi is marketed by Sprout Pharmaceuticals, based in Raleigh, North Carolina.
The FDA, an agency within the U.S. Department of Health and Human Services,
protects the public health by assuring the safety, effectiveness, and security
of human and veterinary drugs, vaccines and other biological products for human
use, and medical devices. The agency also is responsible for the safety and
security of our nation�s food supply, cosmetics, dietary supplements, products
that give off electronic radiation, and for regulating tobacco products.
And can we just say�it's about time. Men have had help for their sexual
dysfunction for decades, but women with low libidos have been left in the cold
to either figure out how to warm ourselves up or be seen as frigid in the
bedroom. We're not saying this pill will be a cure-all, nor are we saying that
you should have sex if you don't want to. But for women who simply want to want
sex, this little pill could be game-changer. (Keep in mind these 5 Common
Libido-Crushers to Avoid.)
"Hypoactive sexual desire disorder (the fancy name for 'not tonight, honey, I
have a headache') affects one in 10 women," says Michael Krychman, M.D., a
sexual medicine gynecologist. He was one the doctors asked to testify at the FDA
hearing that approved the new "wonder drug", but he is not a paid spokesperson
for the drug company that manufactures Addyi. "This is an important solution for
restoring sexual interest in women who feel distressed at the loss of their
desire." (Yikes! There are also these 8 Sex-Related Problems Women Stress Over.)
The drug was rejected twice over the past five years before this final approval.
In those cases, the drug needed more studies and critical questions answered,
which Krychman says Sprout Pharmaceuticals has addressed satisfactorily (a point
that is, of course, up for debate among people who still think the drug is
unsafe).
But know this first: This pill is not Viagra. Because men and women are
different (no surprise there!), a female libido booster has to work on in an
entirely different way. For starters, the male sexual stimulant works by sending
more blood flow to the genitals�the female version affects your mind. Addyi is a
non-hormonal medication that alters key chemicals in the brain to enhance sexual
response, says Krychman. Specifically, it increases dopamine and
norepinephrine�neurotransmitters that are responsible for sexual
excitement�while also decreasing serotonin, the neurotransmitter that is
responsible for sexual satiety or inhibition. (Learn more about The 20 Most
Important Hormones for Your Health.)
If those chemicals sound familiar, it's because they're the ones targeted by
most antidepressants�fitting, since the drug was first created as a mood
stabilizer before scientists recognized its other potent benefits. And similar
to antidepressants, Addyi takes several weeks before you start to feel your
engine revving and up to eight weeks of daily usage before you hit full speed.
It then needs to be taken on a continuous basis, not just when you want to have
sex.
The drug is aimed at pre-menopausal women suffering from low sexual desire but,
at the risk of sounding like one of those annoying drug commercials, it's not
for everyone. For starters, Flibanserin isn't the miracle drug Viagra is. While
80 percent of men who take the little blue pill report a happier ending, only
eight to 13 percent of women who took the little pink pill saw improvement over
taking a placebo, according to a study published recently in JAMA.
Krychman says you'll need to be cleared by a doc first to ensure you're in good
health. You should talk to your doctor if you're already on any medications,
particularly an antidepressant. Most importantly, though, is to consider what
your low libido stems from. (Find out What's Killing Your Sex Drive.) While the
pill may help women in many different situations, Krychman cautions that it
shouldn't be used as a band-aid for controllable causes of low libido like
fatigue, stress, dysfunctional partners, or relationship concerns.
Instead, you should work on those issues first or in conjunction with a medical
approach, he says. Thankfully, there are plenty of non-medicinal ways to up your
desire in the bedroom (and the bathroom and the kitchen...). Never underestimate
the power of a healthy diet and exercise to get all your body functions in peak
form, Krychman says. You can always try herbal supplements as well (Krychman
recommends Stronvivo). Some of our favorite 'script-free methods are these 6
Ways to Lift Your Libido.
But the best thing you can do for your sexual relationship, he says, is work on
your romantic relationship. "We need to prioritize sex with our partner and
rekindle the romance," he explains. He advises going on a digital fast in the
evening and spending more time together uninterrupted.
The rapid post-licensure acquisition of Addyi�s manufacturer, Sprout
Pharmaceuticals, by the Canadian company Valeant for $1 billion implies that
Addyi is some sort of wonder drug � or, at least, that its hype is more about
profit than helping women. And the evidence bears that out a bit. The drug
failed to gain FDA approval twice because of questions about its effectiveness
and how many women it can actually help, especially given some major side
effects.
One of those side effects is a tremendous drawback that some women may not take
as seriously as they need to: you cannot drink alcohol while taking Addyi � and
it�s designed to be taken daily on a regular basis, not just when you want to
want sex. That means total abstinence from alcohol.
Female sexual dysfunction is really prevalent across populations. Mostly
peri-menopausal and post-menopausal women but also women in their 20s and 30s as
well. The best study, she said, is a 1999 study in JAMA that found 43% of women
and 31% of men complained of some form of sexual dysfunction. It is very
distressful for women, and the FDA has approved the drug specifically for �a
lack of sexual desire that causes distress to the woman or in her relationship.�
There are a lot of patients who never have sex, and they�re okay with that. The
only time it�s a problem is if it�s a problem for the woman or her partner. By
definition, it�s a condition that�s causing distress.
What exactly does flibanserin (Addyi) do.That�s what�s really interesting about
this. People are hyping this as the female Viagra, but it�s really different
from Viagra in a couple of important ways. Number one, Viagra works almost 100%
of time for men. But only 1 in 10 women is going to benefit from flibanserin, so
it�s much less effective than Viagra.
Number two, Viagra works by increasing blood flow to the penis, whereas
flibanserin works on neurotransmitters in the brain, almost like
antidepressants. [Flibanserin is actually a failed antidepressant whose
mechanism on mice was to act on serotonin in a way different than other
antidepressants and to increase dopamine.]
Number three, with Viagra, men just take it when they want to have sex. Women
have to take flibanserin every day, and it takes about four weeks to begin to
see an effect. Peak effects aren�t seen until eight weeks.
Consumers and health care professionals are encouraged to report adverse
reactions from the use of Addyi to the FDA�s MedWatch Adverse Event Reporting
program at www.fda.gov/MedWatch or by calling 1-800-FDA-1088.
The 100 mg bedtime dose of Addyi has been administered to about 3,000 generally
healthy premenopausal women with acquired, generalized HSDD in clinical trials,
of whom about 1,700 received treatment for at least six months and 850 received
treatment for at least one year.