A US advisory panel on Thursday urged regulators to
approve a drug nicknamed the “female Viagra” because it could help increase
women’s sex drive.
If the US Food and Drug Administration gives
flibanserin the go-ahead, it would be the first drug on the market to boost
female libido.
The FDA is not required to follow the advice of the
panel, but it often does.
The experts voted 18-6 in favor of allowing the drug
on the market, but with some additional risk-control measures to make sure
doctors prescribe it only to patients who need it and that women are aware of
the risks.
Flibanserin, which is aimed at pre-menopausal women,
can have significant side effects including nausea, dizziness and sleepiness.
“The treatment effects are numerically small,” said
doctor Christina Chang, speaking to the panelists on behalf of the FDA, asking
the committee to weigh in on the evidence of benefits and risks in women
studied.
Safety concerns include sleepiness, fainting, low
blood pressure and the potential for hormonal contraceptives and alcohol use to
make side effects worse, Chang said.
Experts at the hearing also raised questions about the
possibility for the treatment to be used as a “date-rape drug” and the
increased risk of breast cancer seen in one of two studies on lab animals.
But during the public comment period, women who had
taken the drug said the benefits were considerable.
“I am one of the lucky 11,000 women that was a patient
on the flibanserin clinical trial,” said Amanda Parrish, who said she lost
desire for sex with her husband, and their marriage had suffered.
“What a relationship-saving eight months that was. As
if the light switch had been turned on, so was I.”
– Rejected before –
Two attempts at bringing the drug to market have
already failed in 2010 and 2013, given what experts described as inconclusive
advantages when compared to a placebo.
After it was initially rejected by the FDA,
flibanserin was sold by its developer, the German laboratory Boehringer
Ingelheim, to a US firm called Sprout Pharmaceuticals.
According to documents on the FDA website, women
taking flibanserin reported on average 4.4 sexually satisfying encounters per
month, compared to 3.7 in a placebo group and 2.7 before beginning the study.
The difference between flibanserin and a sugar pill
was deemed statistically insignificant in 2010 after a debate among the
committee members which included seven women and four men.
“What I know is that flibanserin, taken each night
worked for me, and worked for my marriage,” said Parrish.
“For me the effects were not modest, but significant.”
Among the six who voted against the approval, concerns
included negative interactions with alcohol, risks such as fainting and low
blood pressure, the drug’s minimal effectiveness and the lack of long-term data
on safety.
But the majority of the experts said the approval should
provide an option for women who suffer from loss of interest in sex for the
first time, as long as “certain risk management options beyond labeling” are
instituted, such as doctor training and post-marketing studies.
The aphrodisiac properties of flibanserin were
discovered accidentally when it was tested as an anti-depressant, the
drug-maker said.
Viagra’s ability to cause an erection was discovered
after it was tested as a heart medication. Other big drug companies have
already thrown in the towel when it comes to developing a female version,
including Pfizer and Procter and Gamble.
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