FILE - In this Friday, Sept. 27, 2013, file photo, a tablet of flibanserin sits on a brochure for Sprout Pharmaceuticals in the company's Raleigh, N.C., headquarters. Sprout Pharmaceuticals, the makers of the twice-rejected pill intended to boost libido in women, will make a third attempt this week at convincing regulators to approve the drug as the first prescription treatment for low sexual desire in women. A panel of FDA experts will discuss the drug at a public meeting Thursday, June 4, 2015 before voting on whether to recommend its approval.(AP Photo/Allen G. Breed, File)
'Female Viagra' gets FDA approval
02:16 - Source: CNN AP

Story highlights

Flibanserin, which some call "female Viagra," is for treatment of hypoactive sexual desire disorder

Women who drink alcohol should not take it

It only works for women with low sex drive; a study suggests about a third of women suffer from this

CNN  — 

A little pink pill made Amanda Parrish feel the physical excitement she felt when she was first dating the man who is now her husband. The romance was hot and heavy.

The Nashville woman was a part of the clinical trial to test “female Viagra,” known by its scientific name flibanserin or Addyi. It’s a drug created to treat women with a low sex drive. After two failed attempts, Sprout Pharmaceuticals finally got approval from the U.S. Food and Drug Administration on Tuesday.

About one-third of women struggle with low sex drive or what doctors call sexual dysfunction, according to a 2002 study. It’s the most common sexual complaint among women. Parrish was one of them.

“It wasn’t that once we started things weren’t good,” Parrish said, describing her sex life with her husband Ben. “It was that I lost my drive to initiate [sex] and be an active participant [in sex] and I found myself more of an obligatory participant.”

“Addyi really gave me back what I had in wanting my husband,” Parrish, 52, said. “It literally is like a light switch for me, turning that back on, which made our intimate times more special.”

Women’s libido ‘extremely complicated’

While Addyi is being referred to as “female Viagra,” it works quite differently.

Men can pop a blue pill before initiating sex and it takes care of an actual physical problem. It gives a man an erection and it allows him to keep it up during sex. The pill does not juice up his emotional appetite for intimacy. Women will have to take Addyi every night.

That’s because it doesn’t work on a physical problem, Addyi targets the chemicals in the brain that impact sexual response. Drugs that target these chemicals fall into the antidepressant category. Doctors who initially developed the drug had originally been testing it as an antidepressant.

Many antidepressants suppress libido, so the researchers asked about sex. Men reported no significant changes. Many of the women in the trials did report an increase in libido.

“From the neck down my body responds just fine, but from the head up, well for years people have been telling women it’s all in our head and I guess it turns out for some women it really is,” Parrish said.

That is what science has shown in the past. Researchers have experimented with giving women testosterone like they do with men to see if there is an increased physical desire, but they haven’t had much success. While sex can be a strictly hormonal urge for men, and more testosterone does help a man maintain his erection, for women it appears testosterone plays a more modest role, according to a 2014 study published in the Journal of Clinical Endocrinology and Metabolism.

Essentially, it takes a lot more to turn women on.

“Women’s interest in sex is extremely complicated,” said Dr. John Randolph, an author of that study. He spoke about it when the study came out last year.

His research looked at data from more than 3,000 women studied over a decade. It showed a correlation between women’s desire for sex and their emotions. Women who reported that they had fewer sad moods and that their relationship left them emotionally satisfied, gave them an increased interest in sex with their partner.

“Mood and an overall sense of health and well-being is key for women,” Randolph said at the time.

Parrish would likely agree. She describes it as “a biological physical problem, but I guess for some women it starts in our brain. So (Addyi) is able to restore that chemical balance back to where it was,” Parrish said.

Side effects, particularly with alcohol

The drug is not problem-free. It comes with some potential side effects that concern the FDA enough to require the drugmaker to put a warning on the box highlighting the risks.

Women who drink alcohol and take the pill could experience severe low blood pressure and because of that drop in blood pressure they could lose consciousness – meaning doctors should advise women not to drink alcohol when taking the pill. The other side effects include dizziness, nausea, fatigue, insomnia and dry mouth. Women who drink alcohol are particularly at risk for complications.

Parrish says she is a social drinker, but didn’t feel any negative effects from the drug.

The manufacturers recommend taking it at night so woman won’t feel the potential adverse reactions such as low blood pressure and sleepiness that can happen when the central nervous system is suppressed.

Addyi also won’t help women who doctors label as having a normal appetite for sex, according to Dr. Anita Clayton. Clayton works as a consultant with Sprout Pharmaceuticals and is interim chair of the department of psychiatry and neurobehavioral sciences at the University of Virginia School of Medicine in Charlottesville. “It doesn’t make you have hypersexual interest,” Clayton said.

Pink pill versus blue pill

“It certainly won’t at all be the panacea that Viagra is at all,” Dr. Laura Berman said. Berman worked on the drug trial and is an assistant professor of clinical obstetrics and gynecology at Northwestern University Feinberg School of Medicine. “It’s not going to have the same impact for the proportion of women as Viagra does on men.”

In clinical trials, women taking the drug experienced a 37% increase in sexual desire, according to Sprout.

“It doesn’t treat all sexual dysfunction, it won’t help all women with sexual problems, but it will have a role in therapy. Just like with any medication, adult women in conjunction with their physicians can make an informed decision about whether this is an appropriate therapy for them,” said Dr. Holly Thacker, an obstetrician gynecologist at the Cleveland Clinic.

Berman said there is also a popular misconception that people will abuse this drug like they may abuse antidepressants, meaning that they would rather pop a pill than work on their emotional issues.

If a relationship has deeper-seeded issues that lead to a lack of desire, this pill won’t fix all of that. That’s why it will merely be a tool to help with the larger problems of sexual desire. And that’s why women will be carefully vetted before doctors write them a prescription. “That’s why there is a screening process and I know the company takes it seriously,” Berman said.

Addyi will cost about the same per month as a one month supply of Viagra for men, Sprout said.

Parrish, who does qualify for the drug, told CNN she cannot wait for it to be on the market in October. It has been awhile since she’s experienced the benefit of this drug when she was a part of this trial.

“I don’t think I can adequately describe my feelings,” Parrish said. “I’m elated and excited. It’s been a long, long, long five years since I was on (Addyi).”