Women who have tried flibanserin in the past, through clinical trials, say its “Pink Viagra” nickname is inaccurate. (Photo: iStock)
Since the U.S. Food and Drug Administration approved flibanserin, a.k.a. “Addyi,” last week (after two previous rejections of the drug), a firestorm of controversy has followed. How effective is the drug, really? How substantial are the side effects? And did the pressure to find the first treatment for female sexual dysfunction ultimately force the FDA’s hand?
Evaluation of flibanserin in clinical trials revealed somewhere between 8 to 13 percent of women said their sexual desire was “much improved,” according to The Journal of the American Medical Association. Critics have noted this is a small percentage in exchange for hefty side effects; Addyi will come with a big warning label from the FDA, saying to avoid alcohol while taking the drug and to only take it at bedtime.
The FDA put female sexual dysfunction — a term that includes the Hypoactive Sexual Desire Disorder (HSDD) that flibanserin treats — on its list of 20 unmet medical needs back in 2011. And, of course, you’ve likely heard the numbers: Men have 24 drugs to treat sexual dysfunction, and women have zero — or now, one, starting Oct. 17 when Addyi is likely to be available at pharmacies.
Addyi-manufacturer Sprout Pharmaceuticals focused its FDA-approval campaign on this very issue of imbalance, supporting 24 women’s groups in their “Even the Score”campaign to help raise awareness for female sexual dysfunction.
Now that flibanserin has the green light, we asked three women who took part in clinical trials for the drug how exactly the drug worked for them — on their sex drives, marriages, and overall well-being.
HSDD: The Huge Shift in Sex Drive
Cara Johnston (Editor’s note: name has been changed) met her husband while still in college. After dating for eight years, they married at age 27. During the first decade or so of their relationship, they enjoyed an active sex life, being intimate three to four times a week.
“But then I had my first son at age 30,” Cara, who is now 44 and lives in Annapolis, Maryland, tells Yahoo Health. “Immediately, I felt something in me had changed. Your body turns from sexual to something for your child. I had no desire for my husband, or for anyone else.”
Cara believed the prevailing wisdom that after she’d had time to settle in with the baby, her sex drive would rev back up. By age 33, she’d had another child, and things had not gotten better. She tried herbal supplements, drinking a special juice for three months. She even tried rubbing testosterone on the inside of her thigh to increase libido. Nothing worked.
The dramatic change in the nature of her relationship was stunning. “I was contemplating divorce,”she says. “I thought that I obviously did not feel love for him if this was happening, and he did not feel loved.”
“He had an outside charter fishing business,” Cara continues. “He worked full-time, I worked full-time, and I was happy he wasn’t around to bother me. At this point, we were living separate lives in the same house.”
Amanda Parrish, 52, from Nashville, Tennessee, tells a story that is much the same as Cara’s. “I’ve heard what people say about desire waxing and waning over time,” she tells Yahoo Health. “And I’d experienced with kids, through my dad dying, with my first marriage and divorce. It had come and gone, but it had always come back.”
Up until 2005. Before this time, Amanda’s relationship with her second husband, Ben, was “sexually charged and equally yoked,”as the two made an active effort to remain physically in sync. “We were both divorced before, and we knew how important it was,” she says. “We really wanted to make this work.”
Amanda and her husband Ben. (Photo courtesy of Amanda Parrish)
Three to four years into the marriage, though, something had changed — and that something was Amanda. “I noticed things were different,” she says. “I never initiated, I invented reasons to stay out later at night, I pretended to be asleep. And yet nothing else had changed.”
So, Amanda and her husband made the effort to reconnect. They bought The Five Love Languages by Gary Chapman. “I was terrified he would end [the relationship] or look elsewhere — and the whole time, he was feeling the same way about me,” she says, “until I was at the doctor, and I found a brochure for the clinical trial for flibanserin.”
She brought it into her appointment. The doctor asked her about her symptoms and after running through the criteria with Amanda, there was an official diagnosis: Hypoactive Sexual Desire Disorder (HSDD).
She went home and told Ben. “There was just nothing else,” Amanda says. “I was confident with my self-image, I was in shape, there was no other stressor. So I said, ‘I think I’ve got a solution, but we’ve never talked about it.’ I’m from the Deep South. As women, we don’t talk about sex — and we certainly don’t enjoy it.”
What Is HSDD Like?
Amanda says she’s concerned that few people properly understand the condition. She describes it as her body reacting normally to sexual stimulation, but the brain not responding in kind — not even a little bit. “You couldn’t pay me a million dollars to get up off that couch,” she says.
She described it to her husband like a daily cup of coffee, which he loves. “If you couldn’t smell that coffee or taste that coffee, would you be as inclined to drink it?”
Barbara Gattuso, a nurse based in San Diego, California, relays her sexual experience very similarly. “You’re doing it out of duty,” she tells Yahoo Health. “It’s a job you’re required to do — but your heart isn’t in it.”
It wasn’t always that way for her, though. Barbara describes her marriage as loving, and she was in love and felt the normal sting of sexual desire. “I knew something was wrong, because I had that loving husband and a strong marriage,” she says. “If I didn’t, we wouldn’t still be together. [HSDD] is a shameful thing. You don’t talk about it. Men don’t usually understand — and they take it personally, because there is no answer. You pull into this shell, and you live with it.”
Now in her mid-60s, and having lived 25 years with HSDD, Barbara has “traveled everywhere” over the course of her life, keeping an eye out just in case someone had uncovered a successful treatment for the condition. “I’ve asked doctors, I’ve asked pharmacists, I’ve asked counselors — I didn’t want to take an antidepressant, because I’m not depressed. There’s never been an answer for this condition. Every time, I hear, ‘I’m so sorry.’”
But then, in 2010, Barbara saw an ad for a clinical trial aiming to treat women with low libido. She met with Irwin Goldstein, MD, the director of sexual medicine at Alvarado Hospital in San Diego. She was put in the double-blind trial.
A bottle of Addyi (flibanserin) tablets. (Photo: Associated Press)
“As a nurse, I am very aware of what’s going into my body,” she says. “I take very little medication, most of my pills are vitamins, and so I was aware that flibanserin was first developed as an antidepressant. I was going through a lot at the time. My dad was sick. So I thought, ‘Either this is going to work as a mild antidepressant, or I’m going to be really sexually motivated.’”
After seven months of the double-blind trial, and no change in her sexual desire, Barbara figured she was on the placebo well before Goldstein told her this was the case. “If the placebo effect was going to work on anyone, it would have worked on me,” she says. “I wanted this drug to work badly.”
But it didn’t. When her doctor asked if she’d like to try flibanserin, she said “of course.”
“After one week of taking the real thing, everything changed,” Barbara says.
Flipping the Switch
While many women believe it has to do with fluctuating hormones, either after childbirth or regularly throughout the course of the life cycle, HSDD is actually thought to be the result of a chemical imbalance in the brain. Taken once per day at bedtime, flibanserin works by temporarily lowering the levels of serotonin in the brain.
Drugs don’t work for everyone, and aren’t one-size-fits-all. But Cara, Amanda, and Barbara all saw flibanserin work in weeks to months.
“It was like a light switch flipped back on, like I was in my 30s again,” Barbara says. “I was sexual again. It was like I’d gotten a piece of my life back.”
It took two weeks for Amanda to experience any change. “Suddenly, I was texting my husband, and I felt this flutter of desire — and not in my heart,” she says. “I was back to the woman I was before. Ben said I exuded femininity.”
Cara felt the flip, too, although it took a little longer than the others. “At first, I didn’t notice it,” she says. “It took about a month. But then one week we made love — and then again that week. I hadn’t thought about it. It’d been years. Three months in, I felt like me again. I started to run again. We were having sex regularly, and our marriage was growing stronger.”
Since the FDA approval of flibanserin last week, it’s been referred to as “pink Viagra” or “female Viagra” almost incessantly. Cara hates this characterization. “I wish it were identified as ‘the marriage drug’ or ‘the relationship drug,’” she explains. “It is a drug that allows you to be open and receptive. Over time, it was simply opening me up to the idea of having sex again.”
Indeed, Sprout Pharmaceuticals tells Yahoo Health that Addyi does not work like Viagra, which improves blood flow to the genitals. Addyi alters key chemicals in the brain that can interfere with sexual desire. Sprout says Addyi is really only similar to Viagra in the effect it could have on treating female sexual dysfunction on a widespread level; as with the launch of Viagra, the approval of Addyi could open the floodgates for more research and treatments for women.
Like with most drugs, flibanserin won’t work for every woman with HSDD; as stats from the JAMA evaluation of the clinical trial indicate, it didn’t. The drug also isn’t meant to fix poor relationships with an extra shot of physical chemistry; the medication will not suddenly make a wife want to have sex with her husband, or vice versa, if the marriage isn’t loving — and healthy, apart from issues with sexual dysfunction.
But for these three women, flibanserin simply opened them up to the idea of sex with their supportive partners. “I finally wanted it again,” Cara says of sex with her husband.
And no, the drug “didn’t make me want to jump everyone’s bones,” Amanda insists —she was simply engaging in her marriage again, participating in the romantic and flirty behaviors that keep the flame alive. “And for the first time in five or six years, we were talking about sex,” she says. “It was a relationship savior for us.”
Barbara agrees wholeheartedly. “The effect is not over-the-top,”she says. “It’s not every second of every day.”
Trials After the Trial
Most of the women describe minimal side effects on the drug — although Cara says flibanserin did cause rapid-onset fatigue.
“I think it’s important people know what it does,” she explains. “I took it right before bed, and it did make me very sleepy. It works very quickly. One time, I’d forgotten to take it the night before, and so I took it in the morning. I had to sit down on the couch with my eyes closed for two or three hours. I could not drive to work.”
Amanda and Cara both engaged in minimal to moderate alcohol consumption while on the drug — Amanda says she “drank socially,” while Cara says she had “one glass of wine per night” — and neither saw any effects. However, they both recommend taking the pill as it will be prescribed (no alcohol consumption while taking the pill).
All three women have now been off flibanserin for several years, as the FDA has in the past denied the drug’s approval, which in turn halted clinical trials in their tracks in 2010. Barbara had barely switched from the placebo to flibanserin when her doctor told her the trial was kaput. “Handing those pills over to him was like pulling out my molars,” she says. “So many emotions were raging inside me. I was sad, I was angry. For years, I’d looked for a solution to this. And now, they were taking it away.”
Since then, Barbara has frequently told her story and advocated on behalf of the drug’s miracle effects.
Cara misses flibanserin’s effects, as well. When she was involved in the trial, she says she probably did not give the drug enough credit. “I thought I was just getting my act together,” she says. “But within one month of going off the medication, I was back to the old me.”
Having desire’s switch flipped back off, for all the women and their husbands, was bittersweet — but there was a silver lining, says Cara. “From then on, my husband and I realized there was a chemical imbalance in me,” she explains. “The drop-off in sex wasn’t because I didn’t love him. I did. I still do.”
Cara says she wants women to understand the science behind how the drug works — that it’s not just due to fluctuating hormones, and that it’s not “normal” to have no interest in sex. It could be HSDD, and it could be a very real problem within the brain. “Knowing that keeps me balanced enough,” she says. “And knowing it’s not a problem with our marriage, but this chemical imbalance, has kept us fighting for our marriage.”
All three women were thrilled when the FDA approved Addyi last week. Amanda celebrated with her husband, Ben — and a bottle of champagne. “He’ll be the one to go and pick it up for me at the pharmacy on Oct. 17,” she says with a laugh.
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