In June, North Carolina-based Sprout Pharmaceuticals relaunched Addyi, sometimes called the “female Viagra,” with a new lower price and an online prescription process.
The company’s CEO, Cindy Eckert, had been responsible for shepherding the drug through its approval process but sold it in 2015 to a competitor she subsequently sued. Eckert is once again in charge and is increasing marketing, lowering the price, unveiling a new website, and expanding into other markets such as Canada. Sprout cut the price from $800 per month to $400, which should mean that women with insurance that covers the drug will only pay $25 for a monthly supply. The company will also ensure that women without insurance don’t have to pay more than $99 per month for the drug.
But questions about whether the drug works and the disorder it’s supposed to treat continue to follow the little pink pill.
Addyi (pronounced “add-ee”) is the brand name for flibanserin, a drug that was originally developed as an antidepressant. It is taken daily at bedtime and works on brain chemistry; the drug decreases levels of serotonin to allow higher levels of dopamine and norepinephrine, chemicals that influence motivation and desire. Despite popular notion that compares Addyi to Viagra, it’s quite different from the erectile dysfunction drug, which increases erection (not desire) by boosting blood flow to the penis.
Addyi was already controversial when it was approved by the Food and Drug Administration (FDA) in 2015 as a cure for women with hypoactive sexual desire disorder (HSDD), a condition in which women have a low sex drive for more than three months and experience stress as a result. Some experts argue that HSDD doesn’t really exist and that the company is retrofitting a diagnosis to fit the drug. They say that sexual desire is a complicated mix of relationship factors, life stress, and societal pressure to want sex—and not necessarily something that needs a medical diagnosis or treatment.
Leonore Tiefer, a sex therapist and former co-director of the Sex and Gender Clinic at Montefiore Medical Center in the Bronx, led the fight against the drug getting FDA approval and recently told Bloomberg Businessweek: “It’s the story of disease mongering. The creation of a condition that’s really not a condition.”
Sheryl A. Kingsberg, chief of the Department of Behavioral Medicine at University Hospitals Cleveland Medical Center, disagrees. Kingsberg was involved in Addyi’s initial approval because her center ran one of the clinical trials.
She told Rewire.News that HSDD is not new but was identified by renowned sex researcher Dr. Helen Singer Kaplan decades ago and has been an accepted diagnosis since the 1980s (it was originally called “inhibited sexual desire”). Various studies estimate that anywhere between 5 and 14 percent of women have HSDD.
Kingsberg likens the debate over HSDD and Addyi to when Prozac and other common antidepressants called selective serotonin reuptake inhibitors (SSRIs) first became available. “This is very similar to discussion on depression we were having 30 years ago. People were told, ‘It’s all in your head. Get over it.’ But then when SSRIs became ubiquitous, that’s when everyone started to realize there is a biological component to this that could be treated.”
Addyi critics have yet another complaint: They aren’t convinced it works.
Ian Kerner, a sex therapist and author based in New York City, told Rewire.News in an email, “In my experience, I haven’t seen much success with Addyi. Desire is complex and determined by so many factors from a biopsychosocial perspective that it’s incredibly difficult to treat medically.”
Reports on Addyi’s efficacy are mixed at best. As Rewire.News reported during the FDA decision-making process, results from studies of Addyi found that women on the medication reported higher levels of desire and lower levels of stress than women taking the placebo. However, this only translated to between 0.5 and one additional sexually satisfying event per month than for women taking a placebo.
For her part, Kingsberg thinks that focusing on the frequency of sex misses the point. She says that women with HSDD are having sex despite the fact that they have low desire. She explained, “Women don’t want to increase the number of sexual events they’re having. They want to want to have sex. That’s what a desire medication should do, improve your appetite.”
Like many drugs, Addyi has side effects, which can include dizziness, nausea, and intense sleepiness. But one study found additional potentially dangerous side effects—including a drop in blood pressure—when Addyi was mixed with alcohol. The FDA approval came with a warning that the drug should not be taken with alcohol, and prescribers and pharmacists have to complete training on how to screen for alcohol use and pass a test on the material before they can dispense the medication. Eckert also plans to go back to the FDA with new research to try to get the alcohol prohibition eased.
In the three years since it got FDA approval, sales of Addyi have been consistently low. Critics of the drug say this is proof that it’s an unnecessary medicalization of female desire. Eckert, however, believes that Addyi’s problems were not with the drug but with the pharmaceutical company that was supposed to bring it to market.
Just two days after FDA approval, Eckert and Bob Whitehead, her ex-husband and business partner, sold Sprout to Valeant, a larger pharmaceutical company that makes drugs for anxiety, gastrointestinal disorders, diabetes, and other medical issues. Though Valeant promised to leave the Sprout team largely in place, Eckert and her co-workers were quickly let go. Around the same time, the Securities and Exchange Commission began investigating Valeant over its accounting methods and the CEO was ultimately forced to resign.
Eckert believes that Addyi got lost in the shuffle. She told Fortune: “The notion that it was launched is a false notion. It was theoretically in the supply chain, but for a woman to have gotten this drug in the last two years was like winning the Powerball.”
She and some of her original investors sued Valeant in 2016, claiming that it had made Addyi too expensive and failed to properly market it. As part of a deal struck at the end of last year, Valeant agreed to give Addyi back to Sprout along with a $25 million loan to help the smaller company with initial operating expenses. In exchange, Sprout dropped the lawsuit and will give Valeant a 6 percent royalty on global sales of the drug moving forward.
Most importantly, Sprout Pharmaceuticals will market the drug far more aggressively than Valeant did, starting with a website that links women to telemedicine providers who can diagnose their HSDD and provide a prescription without ever having met in person.
Kingsberg believes that once more clinicians are educated and the drug is more available to women, sales will improve and the debate over this drug may die down.
“Why not let women and their health care professional make the decision as to whether they need the drug? Give women autonomy. Women are smart. If it doesn’t work, they’re not going to take it.”