After three tries, the FDA Advisory Panel recommends
approval of Flibanserin, also called “female Viagra” or “the little pink pill”. Flibanserin has been recommended for approval
for the treatment of Female Sexual Interest/Arousal Disorder (FSIAD). This disorder is diagnosed in the absence of
another cause and includes a persistent absence or deficiency in sexual
fantasies and desire that causes distress or interpersonal difficulties.
Initially, Flibanserin was studied in 2006 as an
antidepressant. It acts to decrease
serotonin and increase norepinephrine and dopamine in the brain. This is quite different to how Viagra works
by altering the blood flow to the penis during sexual arousal. Flibanserin was not effective as an
antidepressant, but had an unexpected side effect on sexual desire in women
only in the study.
Additional studies designed to calculate the degree of
effect on sexual desire, decrease in distress, and the number of satisfying
sexual events per month showed statistically significant improvement in desire
and an increase of 1 additional sexually satisfying event per month.
The primary side effects include dizziness, fatigue,
sleepiness, and fainting episodes. The
studies on this medication have only included healthy premenopausal women in a very
selected environment. The FDA was
concerned that the risks outweighed the small amount of benefit and denied the
applications for approval on two earlier occasions.
Concerns remain about the use of Flibanserin in combination
with other drugs and a study in mice that showed a possible increase of breast
cancer. The longest study to date was
only 18 months, not long enough to conclusively find any breast cancer risk in
a relatively young age group of women.
On June 4, 2015, the FDA Advisory Panel recommended the drug
for approval. They also strongly
recommended training for physicians and pharmacists on prescribing of the
medication. Black box warnings were also
recommended concerning the use of alcohol and other medications in combination with
the drug.
The FDA generally follows the Advisory Panel recommendations,
however not always. It is possible that
the FDA will override the recommendations and deny approval for a third time. A decision is expected in the next few
months.
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