BackFemale sex-drive pill wins FDA approval in first for US women
Sprout Pharmaceuticals will sell flibanserin under the name Addyi for women who haven't yet gone through menopause and suffer from low libido
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A pill to treat low sexual desire in women won approval from the Food and Drug Administration (FDA), becoming the first such treatment cleared for sale in the US.
Sprout Pharmaceuticals Inc. will sell the drug, flibanserin, under the name Addyi for women who haven’t yet gone through menopause and suffer from low libido, according to a statement from the regulatory agency. The FDA put restrictions on who can prescribe the drug to address serious side effects such as fainting.
The FDA had previously rejected the drug in 2013 for its modest effect, and then faced a backlash from some doctors and researchers who claimed the agency was being sexist. Drugs to treat male sexual dysfunction have become ubiquitous since Pfizer Inc.’s Viagra was approved in 1998. Viagra generated $1.69 billion in sales last year.
“This is a transformational moment, hopefully across all of women’s healthcare, certainly in women’s sexual health," Cindy Whitehead, chief executive officer of Sprout, said in a phone interview. “Our breaking through, I hope, opens the door for a variety of treatments to come forward."
Flibanserin is approved for women diagnosed with a condition called hypoactive sexual desire disorder, which is low libido that causes stress. Sprout wants to make the drug available by 17 October. The company will price it similarly to a month’s supply of Viagra, which is about $350 to $400, Whitehead said.
Fainting, sleeplessness
Doctors will have to take a training course to be certified to prescribe Addyi, and patients will need to sign a form saying they understand the risks, which will also be featured prominently on the label.
Still, the FDA acknowledged that the drug industry has struggled to come up with treatments for female sexual dysfunction and said it continues to encourage development in that area.
Before the FDA ruling on Addyi, some women’s health experts had argued that the drug’s associated risks of fainting and extreme sleepiness outweighed any benefit. Studies found the risks are exacerbated by alcohol and birth-control medicine.
Addyi targets neurotransmitters such as dopamine and norepinephrine that the brain uses to transmit information and can affect mood. Antidepressant drugs use similar mechanisms.
Satisfying events
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, Whitehead said.
Addyi’s label will advise women to stop taking the pill if they don’t respond after eight weeks, Whitehead said.
In June, FDA advisers recommended in an 18-6 vote that the FDA approve the drug. While advisers said the pill’s effect isn’t as strong as they’d like, they said they voted in favour to get the first female sexual desire drug on the market and boost awareness to get better treatments on pharmacy shelves in the future.
About 2 million women are currently seeking treatment for the disorder and more are expected to come forward once Addyi is on the market, said Carl Spana, CEO of Palatin Technologies Inc., which is developing its own female sex-drive treatment.
Palatin is in the final stages of testing its drug bremelanotide for use as needed, like Viagra, while Addyi is taken every night before bed. Palatin estimates the market for low female sexual desire treatments could total $1.3 billion a year, based on the 2 million women known to be affected.
Palatin could bring bremelanotide to market in early 2018, Spana said. The company has had talks with larger drugmakers, which he declined to name, that would likely license bremelanotide for sale. Bloomberg
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