Sex may sell, but so far the so-called “female Viagra” pill hasn’t.
Sales are lackluster and criticism robust for Addyi, the “little pink pill” designed to boost women’s sexual desires. Why is that?
For starters, experts say women’s sexual pleasure doesn’t get much respect as a legitimate medical concern. According to the International Society for Sexual Medicine, about 10 percent of women across all age groups are affected by hypoactive sexual desire disorder (HSDD), a form of sexual dysfunction characterized by little to no desire for sexual activity.
So when Sprout Pharmaceuticals announced the release of Addyi (flibanserin) to treat HSDD, the implications and anticipation were huge.
“There’s always been a big hope that there will be a pharmaceutical option for women who are struggling with sexual dysfunction, and specifically with low libido, and there was great interest in this as the potential [solution],” Dr. Jonathan Schaffir, an OB-GYN at The Ohio State University Wexner Medical Center, told Healthline.
But it didn’t take long after Addyi hit the market in October for critics to question the highly anticipated “little pink pill.” A Bloomberg Business article underscored the drug’s initially low sales and doubted its worth, especially in light of concerns about its safety and efficacy.
Addyi continues to face scrutiny for falling short of market expectations. But some women’s health experts argue that it works as intended. It just isn’t the panacea that it was built up to be.
It’s Not Viagra
Don’t call Addyi the “female Viagra” in front of Dr. James Simon. The reproductive endocrinologist who was involved with early clinical trials for flibanserin has grown weary of the comparison between a medication that targets the central nervous system and one that bolsters blood flow to the penis.
“That comparison is highly detrimental and unfair” for many reasons, Simon told Healthline. The two drugs use completely different mechanisms to influence completely different body systems to address entirely different kinds of dysfunction. In other words, pitting Addyi against Viagra amounts to “apples and oranges,” according to Simon.
“It’s about unrealistic expectations based on Viagra that don’t really apply to women, to women’s sexual health, or to central nervous system drugs,” he said.
The biological differences between men and women dictate how treatments for sexual dysfunction work; meaning an Addyi versus Viagra matchup was never a fair fight.
Treatment of sexual dysfunction in women tends to focus more heavily on emotional factors that could be contributing to the issue, which is why antidepressants are often suggested as a treatment option. In fact, Addyi was first created as an antidepressant and redeveloped to specifically target HSDD.
“The emphasis is that female sexual function is complicated, and I would argue, more complicated, than in men,” said Schaffir, who was involved in early flibanserin trials before the drug was picked up by Sprout. “Erectile dysfunction is not only very common in men, but it’s a very measurable issue that people know right away if it’s working.”
“In women, the most common dysfunctions tend to be around desire and arousal, which tend not to be as measureable,” Schaffir said.
He added that the media couldn’t resist shorthand comparisons that were ultimately misleading and damaging to Addyi’s prospects.
“People played it up a lot in terms of in the media … being called the ‘female Viagra’ and the ‘little pink pill,’ and implying that it would be good for all kinds of sexual dysfunction,” Schaffir said. “I think people really want a story that says there’s a helpful new medication, but maybe it’s been a little overblown and those stories have to be tempered with … realism.”
Fear and Loathing at the FDA
One of the biggest controversies surrounding flibanserin has been its pathway to obtaining FDA approval. Addyi endured a bumpy road, having been rejected by the FDA twice before.
Getting the green light hinged on several provisions aimed at boosting patient protection in the Addyi Risk Evaluation and Mitigation Strategy (REMS). The strategy outlines training which physicians and pharmacists must undergo to properly prescribe and dispense Addyi, which has further unnerved some detractors of the drug.
However, this additional certification is not unusual, Abby Yancey, PharmD, associate professor of pharmacy practice at St. Louis College of Pharmacy.
“There are currently more than 40 medications which the Food and Drug Administration requires additional certification,” Yancey told Healthline, “[which] include everything from treatments of rare genetic disorders to cancer and schizophrenia.”
Consumers may also be turned off by Addyi’s black box warning, the most severe label the FDA puts on packaging for drugs that carry serious risk. Side effects such as dizziness, nausea, fainting, and fatigue were reported in clinical trials. The drug also can’t be taken with alcohol, which can exacerbate these symptoms.
A black box warning isn’t to be taken lightly, but it’s also a label that Simon believes could inspire unfounded fears. Even Cialis — a commonly used erectile dysfunction medication — has a black box warning, he added.
While the FDA’s “approach to safety … is a very conservative one,” Simon said, “they’re trying to protect the public.”
Flibanserin isn’t for everyone. Specifically, it’s for premenopausal women suffering from HSDD whose condition isn’t due to other mental or medical health issues, relationship problems, or other drug use.
“This medication can be beneficial to a very specific group of women,” Yancey said, “[but] most women do not fall into that group.”
Furthermore, women in that group are unlikely to experience a particularly robust change in their sex lives. Addyi won’t increase sexual performance, nor will it improve other factors that may be contributing to sexual dysfunction. Most important to note is that Addyi’s benefits are moderate. In clinical trials, Addyi was found to work slightly better than a placebo, leading some skeptics to question whether it was really worth the risk and effort.
To Simon, even a slight increase in satisfying sexual experiences is meaningful.
“There’s a misconception that the small increase on Addyi above and beyond the baseline plus the placebo effect is a small effect,” he said.
He commends the drug’s ability to bring women closer to the number of satisfying sexual experiences per month that are normal for their age.
“It takes women from being distressed and not wanting to have sex to what is described as normal and not being distressed,” Simon said. “If the drug is capable of returning someone to the normal range and the patient says her distress about being abnormal sexually is gone or nearly gone, what more do we want?”
JoAnn Pinkerton, professor of obstetrics and gynecology at the University of Virginia Health System, says she talks about Addyi every day but hasn’t written many prescriptions for it yet. According to Pinkerton, Addyi’s modest benefits required daily intake and provisions such as abstaining from alcohol may be unappealing to some consumers.
“It’s hard for women to take an expensive medication on a daily basis to see if it’s going to work,” she told Healthline. A monthly Addyi prescription costs about $780 without insurance.
Yancey also noted that a patient who already struggles to consistently take medication is unlikely to continue with Addyi unless she really believes there will be a payoff.
“Data by the CDC and others show about half of all patients have difficulty taking their medication as prescribed, even for critical medication to control diabetes, cholesterol, and blood pressure,” she said. “A patient may not even get to the point where she would see a benefit.”
Addyi is just one possible tool in the arsenal for combating low sexual desire in women. Pinkerton takes a top-down approach to counseling patients about sexual dysfunction.
“Trying to tease out where that’s coming from is the first step,” she said.
Pinkerton views Addyi as an option for women with sexual dysfunction, but counseling women who are dealing with sexual dysfunction involves more than just suggesting a pill. Pinkerton considers her patients’ life stressors, relationship troubles, and other factors that could be contributing to an unsatisfying sex life.
“I think it’s a great option,” she said. “I don’t have any hesitation to prescribe it.”
Despite the concerns, there is optimism among healthcare experts like Pinkerton who find Addyi to be an innovative treatment for HSDD and are pleased to see more attention being invested toward women’s sexual health. For example, Schaffir sees Addyi as a model for future sexual dysfunction medication.
Pinkerton is also excited about the dialogue that Addyi may inspire. She predicts that Addyi will help women become better informed about HSDD and encourage them to engage in more discussions with their providers about finding the best treatment for sexual dysfunction.
“We now have an FDA-approved treatment for low sexual desire, which is amazing, and we have to find its place and when and how to prescribe it,” she said.
Skepticism of Addyi could shift as more information becomes available.
“Everyone needs to share in the responsibility to use drugs properly, to portray them properly to the media and to patients and to be honest about the fact that there is no perfect drug,” Simon said.