First female libido drug approved in US could be on its way to Australia

By Julia Medew and Health Editor

The company behind the world’s first drug approved to treat low sexual desire in women is hoping to bring the “pink pill” to Australia.

Sprout Pharmaceuticals – the company that on Wednesday won approval to sell its female libido drug “Addyi” in the US – wants to start working with international drug regulators to market the product globally.

The first drug approved in the US to treat low sex drive in women could be coming to Australia. Credit: Yuri Arcurs

“The company is committed to working closely with other regulatory bodies outside the US in the future to bring to market a safe and effective treatment for the many women around the world affected by distressing low sexual desire,” a spokeswoman said.

FIVE THINGS YOU SHOULD KNOW ABOUT THE NEW FEMALE SEX DRUG

• It is a once-a-day pill that will cost about $400 a month.
• It can only be prescribed to pre-menopausal women.
• Up to 50 percent of women in clinical trials experienced one extra “satisfying sexual event” a month, regardless of whether that produces an orgasm.
• It is a failed anti-depressant that targets neurotransmitters in the brain that can affect mood.
• It makes some people dizzy and faint, particularly if they’re drinking alcohol or taking contraceptive medicines.

She could not say, however, when the company would apply to register the once-a-day pill with Australia’s drug regulator, the Therapeutic Goods Administration. TGA registration is a necessary step for Australian doctors to prescribe the drug.

From October, 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 US drug regulatory agency.

Flibanserin, a failed anti-depressant that will cost about $400 a month, led to a median of 0.5 to one extra “satisfying sexual event” a month for women in clinical studies. That event could be anything from genital stimulation by a partner to masturbation, oral sex or intercourse, irrespective of whether it led to an orgasm.

The Food and Drug Administration 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 health care, certainly in women’s sexual health,” Cindy Whitehead, chief executive officer of Sprout, said. “Our breaking through, I hope, opens the door for a variety of treatments to come forward.”

Flibanserin has now been approved for women diagnosed with a controversial condition called hypoactive sexual desire disorder, which is low libido that causes stress. Some commentators believe the condition has been partly created by drug companies seeking to cash in on what could be normal behaviour.

Before the FDA ruling on flibanserin, some women’s health experts had also argued that the drug’s associated risks of fainting and extreme sleepiness outweighed any benefit. Studies found the risks are exacerbated by alcohol and contraception medicines.

Unlike Viagra, which increases blood flow to the penis to help create an erection, flibanserin targets neurotransmitters such as dopamine and norepinephrine that the brain uses to transmit information and can affect mood. Antidepressant drugs use similar mechanisms.

In clinical trials, women who took flibanserin 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, Ms Whitehead said.

Addyi’s label will advise women to stop taking the pill if they don’t respond after eight weeks, Ms 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 favor to get the first female sexual desire drug on the market and boost awareness to get better treatments on pharmacy shelves in the future.

Amanda Parrish, a 52-year-old woman who participated in a clinical trial of the drug for eight months, said her sex drive started to improve after about two weeks.

“It brought me back to where I was. Before long, I was the one suggesting we skip dessert and go back home to bed,” she wrote in Time magazine this year.

Ms Parrish said the quality of her sex life with her husband Ben also improved during the trial.

“I was taught that for sex, men need a place, and women need a reason. But what I found was that Ben responded differently to me when he knew I wanted him,” she wrote.