FDA officials finally approved the first-ever
prescription drug intended to treat women suffering from a lack of sexual
desire. That is correct – Women Viagra exists, and will be appearing on the
market late October.
Sprout Pharmaceuticals Inc. will sell the drug,
flibanserin, under the name Addyi for women who have not yet gone through
menopause and suffer from low libido, according to a statement from the
regulatory agency.
However, the FDA put restrictions on who can prescribe
the drug to address serious side effects such as fainting if combined with
certain other drugs or alcohol. Additionally, doctors will not be able to
prescribe it unless they complete an online certification test.
How does it work?
Addyi acts on brain chemicals associated with mood and
appetite, similar to antidepressant drugs. In fact, it was originally studied
as a treatment for depression before being repurposed into a libido drug. It is
not entirely clear why the drug increases sexual desire but researchers point
to its ability to increase dopamine — a brain chemical associated with appetite
— while lowering serotonin — another chemical linked with feelings of
satiation.
Who will take this
drug?
The FDA approved Addyi for premenopausal women with
hypoactive sexual desire disorder, described as a lack of sexual appetite that
causes emotional distress.
Surveys estimate that between 5.5 million to 8.6 million
U.S. women have the condition, or roughly 8 to 14 percent of women ages 20 to
49. Because so many other factors affect sexual appetite, there are a number of
alternate causes, doctors must rule out before diagnosing the condition,
including relationship problems, medical conditions and mood issues caused by
other medications like sleeping aids and painkillers.
The diagnosis is not universally accepted and many
psychologists argue that low sex drive should not be considered a medical
condition.
The rumors are
this decision was controversial, why?
The drug followed a long, contentious path to approval,
including two previous rejections by the FDA. For years, two opposing sides
have argued over the fate of the drug.
On one hand, drugmakers and some medical experts argue
that women need FDA-approved medications to treat sexual disorders, which they
consider serious medical problems. On the other side, consumer-safety advocates
have said the drug's side effects are too risky, and there are those who
question whether low libido is a medical condition.
On top of this debate, Sprout Pharmaceuticals enlisted
outside politicians and women's groups to lobby the FDA to approve the drug.
Does the drug
work?
Experts usually describe Addyi's effect as
"modest." In company studies, women taking flibanserin reported a
slight increase in sexually satisfying events each month. Their answers to
separate questionnaires indicated they experienced a slight increase in desire
and a slight decrease in stress.
While FDA scientists describe these effects as
"small," they were significant enough to meet FDA effectiveness
standards.
In clinical trials, women who took Addyi recorded a
median increase of 0.5 to one more satisfying sexual events each month than
those who got a placebo. Women began the trials experiencing two to three
satisfying sexual events a month. Some women experienced as many as six to
eight more satisfying sexual events each month.
Addyi’s label will advise women to stop taking the pill
if they do not respond after eight weeks.
What are the side
effects?
About 10 percent of patients in Sprout's studies
experienced the most common problems: dizziness, fatigue and nausea. The drug
will also bear a boxed warning that women should not drink alcohol or take
certain types of other medications, including antifungal drugs, because of an
interaction that can cause low blood pressure and fainting.
How much will it
cost?
Sprout says women who have health insurance will pay
between $30 and $75 for a month's supply of Addyi, depending on their coverage
terms.
History of
Research
The search for a pill to treat women's sexual
difficulties has been something of a holy grail for the pharmaceutical
industry. It was pursued, and later abandoned, by Pfizer, Bayer and Procter
& Gamble, among others. All drugs that act on blood flow, hormones and
other biological functions, were proved being ineffective.
Sources and
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