Referred to as “female Viagra” or “pink Viagra,” Sprout Pharmaceuticals’ flibanserin (aka Addyi) will treat women who suffer from hypoactive sexual desire disorder. (Photo: iStock)
There are currently 26 drugs out there to treat forms of sexual dysfunction in men, and that does not include the additional 15 generic medications on the market. Women, on the other hand, have never even had one drug to tackle such issues — until now.
The U.S. Food and Drug Administration on Tuesday evening approved the first drug aimed at increasing sexual desire in women. Referred to as “female Viagra”or “pink Viagra,” Sprout Pharmaceuticals’ flibanserin (aka Addyi) has the potential to affect millions of women who suffer from hypoactive sexual desire disorder (HSDD).
Yahoo Global News Anchor Katie Couric investigates the science behind the pink pill. (Video: Yahoo News)
Flibanserin will be a groundbreaking first step in treatment of female sexual dysfunction. Here’s what you should know about this first drug of its kind and the long road to FDA approval.
1. The pink pill has been approved — but with stringent safety measures
The drug’s label will bear a boxed warning — the most serious type — alerting doctors and patients to the risks of dangerously low blood pressure and fainting, especially when the pill is combined with alcohol. The same problems can occur when taking the drug with other commonly prescribed medications, including antifungals used to treat yeast infections.
“Patients and prescribers should fully understand the risks associated with the use of Addyi before considering treatment,” said Dr. Janet Woodco*ck, director of the FDA’s drug center, in a statement.
Under an FDA-imposed safety plan, doctors will only be able to prescribe Addyi after completing an online certification process that requires counseling patients about Addyi’s risks. Pharmacists will also need certification and will be required to remind patients not to drink alcohol while taking the drug.
These safety measures mean that flibanserin will most likely never achieve the sales of Viagra, which has generated billions of dollars since the late 1990s — and some critics say the side effects of the drug outweigh the benefits.
2. Women have been complaining about lacking desire for years.
Lisa Dabney, MD, director of the Division of Urogynecology in the Department of Obstetrics and Gynecology at Mount Sinai Roosevelt, says she often has patients come into her clinic to discuss this very issue. “There’s definitely a demand for this drug,”she tells Yahoo Health. “I see women in their 30s, 40s and 50s who have been lamenting that there’s nothing to help with a lack of desire.”
(Photo: Sprout Pharmaceuticals)
In 2011, the FDA put female sexual dysfunction (an umbrella term that would include HSDD) on a list of 20 unmet medical needs where no safe and effective treatment was currently available. With the support of Sprout Pharmaceuticals, 24 women’s groups started the “Even the Score” campaign to raise awareness for the cause, announcing this past spring that 11 members of Congress have gone on record to support flibanserin.
3. It’s been a long road to find a drug for waning sexual desire in women.
Sexual desire and dysfunction is a complicated issue, especially in women. Questions abound: How much desire is normal? How do we measure efficacy of drugs? What mechanisms should we target? “It’s all very complicated,” says Dabney, who says the FDA constantly has to “balance efficacy levels against the potential of side effects.”
If a drug is really beneficial and potentially life-saving, the agency will usually greenlight with more potential issues that may arise as a result of the medication. “But generally, if the potential benefits are lower or not as widespread, the FDA won’t tolerate significant side effects.” So, in weighing safety versus efficacy, the FDA hasn’t been impressed with any drug targeting libido issues in women thus far.
Researchers have been burning the midnight oil trying to decode the mystery of female sexual dysfunction for some time. Yet, in 2004, Pfizer suspended clinical trials of Viagra in women. Like in men, the drug increased blood flowing to the genital region — but unlike in men, this did not seem to affect desire.
4. With that in mind, “pink Viagra” is not Viagra.
In recent years, researchers have focused on increasing desire by looking at the female brain. This is how Sprout’s flibanserin works. “The drug works by modulating neurochemicals in the brain,” Dabney says. “Specifically, it temporarily lowers serotonin, which is thought to have some effect in increasing libido.”
Specifically, in trials, flibanserin has targeted HSDD in premenopausal women. In February, Sprout submitted documents saying that 46 to 60 percent of women responded to the drug in clinical trials. In June, an FDA advisory committee reviewed the drug and voted 18-6 in favor of approval.
5. If you’re interested, ask your doctor about it.
Dabney notes that the recommended dose is a 100-milligram pill once per day at bedtime.
“A couple of the major side effects include fatigue and dizziness,” she explains. “This is why it’s advised you take the medication at night, to mitigate the effects of the fatigue.”
When might the pill be available? Now that flibanserin is approved, Dabney says providers, once they go through the proper protocols, will have the OK to prescribe it, so you can ask your doc now about whether or not the drug might help you with desire.
- with additional reporting by The Associated Press
Read This Next: Is Pink Viagra a ‘Sham Drug’? Top Experts Think So
