A decision whether to approve a drug nicknamed the "female Viagra" is awaited by US regulator Food and Drug Administration (FDA) on Tuesday (August 18), which would be the first pill on the market to raise women's libido.
In June, an advisory panel to the FDA urged regulators to approve the drug, Flibanserin, after previously declining the drug twice in past years.
This time, the experts voted 18-6 in favour of allowing the drug on the market, but with some additional risk-control measures.
While it comes with a set of risks that women should be aware of before taking a pill, Doctors are advised to prescribe it only to patients who need it.
‘The FDA is not required to follow the advice of the panel, but it often does’, a spokesperson for Sprout Pharmaceuticals in North Carolina said.
Marketed towards pre-menopausal women, an FDA spokesperson declined to comment on further proceedings. If approved, Flibanserin would be sold under the name "Addyi", and.
Side effects of Female Viagra
It can have side effects for women to take it, includes nausea, dizziness and sleepiness. Safety concerns include sleepiness, fainting, low blood pressure and the potential for hormonal contraceptives and alcohol use to make side effects worse.
Also, experts raised questions about the increased risk of breast cancer seen in one of two studies on lab animals.
The drug acts on neurotransmitters in the brain and is a non-hormonal agent. It aims to treat a condition known as hypoactive sexual desire disorder (HSDD), or loss of interest in sex, among women who have not entered menopause.
An assistant professor of medical sciences, Rebecca Zucconi, at the Frank H. Netter School of Medicine at Quinnipiac University, said the condition is the most commonly diagnosed sexual dysfunction in women.
"Until now, physicians have been limited to recommending education, counseling, psychotherapy and, in some cases, off-label usage of testosterone and estrogen therapy as treatment options for otherwise healthy women with HSDD," Zucconi said.
"Importantly, the advisory panel gave its approval with specific concerns regarding Flibanserin's safety when combined with certain medications or with alcohol. "If approved by the FDA, Flibanserin will likely be marketed and prescribed with explicit restrictions to this effect."
Earlier, attempts to bring the drug to market failed in 2010 and 2013, given its side effects.
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.
(with agency inputs)
By Sree Teja
