Washington: US regulator Food and Drug Administration (FDA) on Tuesday approved a drug nicknamed the “female Viagra”, which would be the first pill on the market to raise women’s sex drive.
However, safety restrictions on the daily pill – called Addyi – mean it will probably never achieve the blockbuster sales of men’s impotence drugs like Viagra, which have generated billions of dollars.
The new drug’s label will carry a bold warning that combining it with alcohol can cause dangerously low blood pressure and fainting. Those problems can also occur if the drug is taken alongside certain common medications, including drugs used to treat yeast infections.
The Food and Drug Administration approval on Tuesday, marked an unusual turnaround for the agency. The FDA previously rejected the drug twice due to lacklustre benefits and worrisome side effects.
In June, an advisory panel to the FDA urged regulators to approve the drug, Flibanserin, after previously voting against it 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 to make sure doctors prescribe it only to patients who need it while ensuring that women are aware of the risks.
The FDA is not required to follow the advice of the panel, but it often does.
It can have significant side effects including 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. Experts also raised questions about the increased risk of breast cancer seen in one of two studies on lab animals.
Most commonly diagnosed disorder
The drug is a non-hormonal agent that acts on neurotransmitters in the brain, and aims to treat a condition known as hypoactive sexual desire disorder (HSDD), or loss of interest in sex, among women who have not yet entered menopause.
Rebecca Zucconi, an assistant professor of medical sciences 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.”
Two attempts at bringing the drug to the market failed in 2010 and 2013, given that experts described as inconclusive advantages when compared to a placebo. 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.
